Ignite Creation Date:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2025-12-26 @ 2:42 PM
Study NCT ID:
NCT00276406
Status:
COMPLETED
Last Update Posted:
2012-11-30
First Post:
2006-01-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Use of Pyridostigmine for Constipation in Diabetics
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011729', 'term': 'Pyridostigmine Bromide'}], 'ancestors': [{'id': 'D011726', 'term': 'Pyridinium Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bharucha.adil@mayo.edu', 'phone': '507-284-6439', 'title': 'Adil E. Bharucha, MD', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected for the baseline (9 days) and treatment (7 days) periods. Events occuring in more than one subject are tabulated by treatment arm.', 'eventGroups': [{'id': 'EG000', 'title': 'Pyridostigmine', 'description': 'Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.', 'otherNumAtRisk': 16, 'otherNumAffected': 11, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.', 'otherNumAtRisk': 14, 'otherNumAffected': 5, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Increased salivation and/or sweating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle twitching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal discomfort, nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue, lightheadedness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bluish discoloration of urine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Colonic Geometric Center at 24 Hours (GC24) Measured by Scintigraphy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pyridostigmine', 'description': 'Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.96', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '1.98', 'spread': '0.17', 'groupId': 'OG001'}]}]}, {'title': 'Treatment', 'categories': [{'measurements': [{'value': '2.45', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '1.84', 'spread': '0.16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Analysis was adjusted for BMI and baseline values and incorporated Bonferroni corrections.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline period (days 7-9 ), Treatment period (days 14-17)', 'description': 'The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images of the abdomen are taken hourly for the first 6 hours after the radio-labeled meal, then at 8, 24 and 48 hours. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool. GC24 is the measurement taken at 24 hours after the radio-labeled meal.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Ascending Colon Emptying Half-time (AC t1/2) Measured in Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pyridostigmine', 'description': 'Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '16.73', 'spread': '2.30', 'groupId': 'OG000'}, {'value': '20.59', 'spread': '3.29', 'groupId': 'OG001'}]}]}, {'title': 'Treatment', 'categories': [{'measurements': [{'value': '10.44', 'spread': '1.40', 'groupId': 'OG000'}, {'value': '18.77', 'spread': '3.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline period (days 7-9 ), Treatment period (days 14-17)', 'description': 'Calculated by linear interpolation of values on the AC emptying curve.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Gastric Emptying Half-time (GE t1/2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pyridostigmine', 'description': 'Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '142', 'spread': '19', 'groupId': 'OG000'}, {'value': '141', 'spread': '12', 'groupId': 'OG001'}]}]}, {'title': 'Treatment', 'categories': [{'measurements': [{'value': '122', 'spread': '13', 'groupId': 'OG000'}, {'value': '121', 'spread': '13.42', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline period (9 days), Treatment period (7 days)', 'description': 'The measure of time for 50 percent of a radio-labeled meal to empty from the stomach.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Colonic Filling at 6 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pyridostigmine', 'description': 'Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '37', 'spread': '9', 'groupId': 'OG000'}, {'value': '41', 'spread': '10', 'groupId': 'OG001'}]}]}, {'title': 'Treatment', 'categories': [{'measurements': [{'value': '53', 'spread': '7', 'groupId': 'OG000'}, {'value': '48', 'spread': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline period (9 days), Treatment period (7 days)', 'description': 'The proportion of a radio-labeled meal in the colon at 6 hours (identifiable by radio-labelled tracer to capsule eaten with meal), measured by scintigraphy. This is an indirect measurement of small-bowel transit time.', 'unitOfMeasure': 'percentage of meal', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Colonic Geometric Center at 48 Hours (GC48) as Measured by Scintigraphy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pyridostigmine', 'description': 'Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.92', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '2.97', 'spread': '0.27', 'groupId': 'OG001'}]}]}, {'title': 'Treatment', 'categories': [{'measurements': [{'value': '3.59', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '3.26', 'spread': '0.27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.096', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Analysis was adjusted for BMI and baseline values and incorporated Bonferroni corrections.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline period (days 7-9 ), Treatment period (days 14-17)', 'description': 'The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly for the first 6 hours after the radio-labeled meal, then at 8, 24 and 48 hours. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool. GC48 is the measurement taken at 48 hours after the radio-labeled meal.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Stool Frequency Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pyridostigmine', 'description': 'Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.95', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': 'Treatment', 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Daily during baseline period (9 days), Treatment period (7 days)', 'description': 'During 9 days of the baseline period and during 17 days of the treatment period, subjects used a daily diary to record the number of times per day they had a bowel movement. Only the 7 days of highest treatment dose will be used for comparison purposes.', 'unitOfMeasure': 'Number of bowel movements', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Stool Form/Consistency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pyridostigmine', 'description': 'Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.5', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Treatment', 'categories': [{'measurements': [{'value': '3.4', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Bowel diaries were analyzed by computing the mean scores for the 9-day baseline period and separately for the last 7 days of the treatment period (i.e., when the pyridostigmine dose was stable in each subject.) Individual subject treatment period mean bowel function scores were then compared using a similar ANCOVA model, with the corresponding individual subject baseline mean bowel function score and gender as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Daily during baseline period (9 days), Treatment period (7 days)', 'description': 'During 9 days of the baseline period and during 17 days of the treatment period, subjects used a daily diary to record a description of stool consistency according to the Bristol Stool Form Scale (ranging from 1 (hard lumps) to 7 (watery)). The Bristol Stool Scale is a medical aid designed to classify the form of human feces into seven categories or types. Types 1 and 2 indicate constipation with 3 and 4 being the "ideal stools" especially the latter, as they are the easiest to defecate, and 5-7 tending towards diarrhea.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Stool Ease of Passage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pyridostigmine', 'description': 'Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.5', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': 'Treatment', 'categories': [{'measurements': [{'value': '3.8', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.04', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Bowel diaries were analyzed by computing the mean scores for the 9-day baseline period and separately for the last 7 days of the treatment period (i.e., when the pyridostigmine dose was stable in each subject.) Individual subject treatment period mean bowel function scores were then compared using a similar ANCOVA model, with the corresponding individual subject baseline mean bowel function score and gender as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Daily during baseline period (9 days), Treatment period (7 days)', 'description': 'During 9 days of the baseline period and during 17 days of the treatment period, subjects used a daily diary to record a description of stool ease of passage of stool, according to the Bristol Stool Form Scale (ranging from 1 (manual disimpaction) to 7 (incontinence)). Only the 7 days at highest treatment dose will be used for comparison purposes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sense of Completely Emptying Bowels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pyridostigmine', 'description': 'Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '86', 'spread': '6', 'groupId': 'OG000'}, {'value': '74', 'spread': '8', 'groupId': 'OG001'}]}]}, {'title': 'Treatment', 'categories': [{'measurements': [{'value': '73', 'spread': '8', 'groupId': 'OG000'}, {'value': '66', 'spread': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Daily during baseline period (9 days), Treatment period (7 days)', 'description': 'During 9 days of the baseline period and during 17 days of the treatment period, subjects used a daily diary to record whether or not they felt they had completely emptied their bowels(1= Yes; 0= No). Only the 7 days of highest treatment dose will be used for comparison purposes.', 'unitOfMeasure': 'percentage of bowel movements', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Stool Frequency Per Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pyridostigmine', 'description': 'Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.1', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Treatment', 'categories': [{'measurements': [{'value': '4.0', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Daily during baseline period (9 days), Treatment period (7 days)', 'description': 'During 9 days of the baseline period and during 17 days of the treatment period, subjects used a daily diary to record the number of times per day they had a bowel movement. Complete spontaneous bowel movements per week are reported. Only the 7 days of highest treatment dose will be used for comparison purposes.', 'unitOfMeasure': 'Number complete bowel movements per week', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Heart Rate Before and After Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pyridostigmine', 'description': 'Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '74', 'spread': '3', 'groupId': 'OG000'}, {'value': '76', 'spread': '4', 'groupId': 'OG001'}]}]}, {'title': 'Treatment', 'categories': [{'measurements': [{'value': '66', 'spread': '2', 'groupId': 'OG000'}, {'value': '75', 'spread': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline period (9 days), Treatment period (7 days)', 'description': 'Heart rate is the number of beats per minute, as recording on an Electrocardiogram (ECG).', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'QTc Interval Before and After Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pyridostigmine', 'description': 'Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '428', 'spread': '6', 'groupId': 'OG000'}, {'value': '420', 'spread': '8', 'groupId': 'OG001'}]}]}, {'title': 'Treatment', 'categories': [{'measurements': [{'value': '415', 'spread': '18', 'groupId': 'OG000'}, {'value': '421', 'spread': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline period (9 days), Treatment period (7 days)', 'description': 'The corrected QT interval (QTc) is a measurement of time (seconds) between the Q and T waves of an heart beat as recorded during an Electrocardiogram (ECG).', 'unitOfMeasure': 'Milliseconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pyridostigmine', 'description': 'Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '14 of 16 subjects tolerated 360mg daily, while 2 of 16 tolerated 180mg daily.', 'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited from Mayo Clinic in Rochester, Minnesota and the study was conducted at between May 2006 and October 2010.', 'preAssignmentDetails': '68 patients were assessed for eligibility. 24 were ineligible. 13 were eligible but declined to participate in the study. One patient consented but was withdrawn because of severe hyperglycemia during the baseline period. 30 were enrolled and completed all study procedures.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pyridostigmine', 'description': 'Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.5', 'spread': '11.4', 'groupId': 'BG000'}, {'value': '52.1', 'spread': '11.3', 'groupId': 'BG001'}, {'value': '50.2', 'spread': '11.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '27.9', 'spread': '4.4', 'groupId': 'BG000'}, {'value': '31.6', 'spread': '6.0', 'groupId': 'BG001'}, {'value': '29.7', 'spread': '5.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Body Mass Index (BMI) is a health index for comparing weight to height. BMI is a person's weight in kilograms (kg) divided by his or her height in meters squared. The body mass index is an indication if a person is at a suitable weight for his height on an approximation of body fat. A body mass index of under 20 is considered to be underweight, while a body mass index between 20 to 25 is considered healthy. A body mass index in the range of 25 to 30 is regarded as overweight. A body mass index over 30 is regarded as obese.", 'unitOfMeasure': 'kilograms/meter^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hemoglobin A1c', 'classes': [{'categories': [{'measurements': [{'value': '8.1', 'spread': '1.7', 'groupId': 'BG000'}, {'value': '7.7', 'spread': '1.2', 'groupId': 'BG001'}, {'value': '7.9', 'spread': '0.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Hemoglobin A1c (HgA1c) or glycolated hemoglobin is a laboratory test of blood which provides a measure the average blood glucose (sugar) levels for the prior 3 month period.', 'unitOfMeasure': 'Percentage', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Subjects with diabetic retinopathy', 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Diabetic retinopathy is a condition of the eye caused by diabetes, caused by abnormal blood vessel growth, which invades the retina and can cause reduced vision and blindness.\n\nNote: because not all subjects had retinopathy, the number of subjects with retinopathy in each arm will not match the overall number of subjects enrolled in each arm.', 'unitOfMeasure': 'Participants'}, {'title': 'Geometric Center (GC) of Colonic transit', 'classes': [{'title': 'Geometric Center of Colonic Transit at 24 hr (GC24', 'categories': [{'measurements': [{'value': '1.96', 'spread': '0.71', 'groupId': 'BG000'}, {'value': '1.98', 'spread': '0.62', 'groupId': 'BG001'}, {'value': '1.97', 'spread': '0.66', 'groupId': 'BG002'}]}]}, {'title': 'Geometric Center of Colonic Transit at 48 hr (GC48', 'categories': [{'measurements': [{'value': '2.92', 'spread': '0.89', 'groupId': 'BG000'}, {'value': '2.97', 'spread': '1.00', 'groupId': 'BG001'}, {'value': '2.94', 'spread': '0.93', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The scintigraphic method is used to measure movement of large intestine contents. A radio-labeled isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule taken by mouth with a meal. Abdominal anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-02', 'studyFirstSubmitDate': '2006-01-11', 'resultsFirstSubmitDate': '2012-11-02', 'studyFirstSubmitQcDate': '2006-01-11', 'lastUpdatePostDateStruct': {'date': '2012-11-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-11-02', 'studyFirstPostDateStruct': {'date': '2006-01-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Colonic Geometric Center at 24 Hours (GC24) Measured by Scintigraphy', 'timeFrame': 'Baseline period (days 7-9 ), Treatment period (days 14-17)', 'description': 'The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images of the abdomen are taken hourly for the first 6 hours after the radio-labeled meal, then at 8, 24 and 48 hours. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool. GC24 is the measurement taken at 24 hours after the radio-labeled meal.'}, {'measure': 'Ascending Colon Emptying Half-time (AC t1/2) Measured in Hours', 'timeFrame': 'Baseline period (days 7-9 ), Treatment period (days 14-17)', 'description': 'Calculated by linear interpolation of values on the AC emptying curve.'}], 'secondaryOutcomes': [{'measure': 'Gastric Emptying Half-time (GE t1/2)', 'timeFrame': 'Baseline period (9 days), Treatment period (7 days)', 'description': 'The measure of time for 50 percent of a radio-labeled meal to empty from the stomach.'}, {'measure': 'Colonic Filling at 6 Hours', 'timeFrame': 'Baseline period (9 days), Treatment period (7 days)', 'description': 'The proportion of a radio-labeled meal in the colon at 6 hours (identifiable by radio-labelled tracer to capsule eaten with meal), measured by scintigraphy. This is an indirect measurement of small-bowel transit time.'}, {'measure': 'Colonic Geometric Center at 48 Hours (GC48) as Measured by Scintigraphy', 'timeFrame': 'Baseline period (days 7-9 ), Treatment period (days 14-17)', 'description': 'The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly for the first 6 hours after the radio-labeled meal, then at 8, 24 and 48 hours. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool. GC48 is the measurement taken at 48 hours after the radio-labeled meal.'}, {'measure': 'Stool Frequency Per Day', 'timeFrame': 'Daily during baseline period (9 days), Treatment period (7 days)', 'description': 'During 9 days of the baseline period and during 17 days of the treatment period, subjects used a daily diary to record the number of times per day they had a bowel movement. Only the 7 days of highest treatment dose will be used for comparison purposes.'}, {'measure': 'Stool Form/Consistency', 'timeFrame': 'Daily during baseline period (9 days), Treatment period (7 days)', 'description': 'During 9 days of the baseline period and during 17 days of the treatment period, subjects used a daily diary to record a description of stool consistency according to the Bristol Stool Form Scale (ranging from 1 (hard lumps) to 7 (watery)). The Bristol Stool Scale is a medical aid designed to classify the form of human feces into seven categories or types. Types 1 and 2 indicate constipation with 3 and 4 being the "ideal stools" especially the latter, as they are the easiest to defecate, and 5-7 tending towards diarrhea.'}, {'measure': 'Stool Ease of Passage', 'timeFrame': 'Daily during baseline period (9 days), Treatment period (7 days)', 'description': 'During 9 days of the baseline period and during 17 days of the treatment period, subjects used a daily diary to record a description of stool ease of passage of stool, according to the Bristol Stool Form Scale (ranging from 1 (manual disimpaction) to 7 (incontinence)). Only the 7 days at highest treatment dose will be used for comparison purposes.'}, {'measure': 'Sense of Completely Emptying Bowels', 'timeFrame': 'Daily during baseline period (9 days), Treatment period (7 days)', 'description': 'During 9 days of the baseline period and during 17 days of the treatment period, subjects used a daily diary to record whether or not they felt they had completely emptied their bowels(1= Yes; 0= No). Only the 7 days of highest treatment dose will be used for comparison purposes.'}, {'measure': 'Stool Frequency Per Week', 'timeFrame': 'Daily during baseline period (9 days), Treatment period (7 days)', 'description': 'During 9 days of the baseline period and during 17 days of the treatment period, subjects used a daily diary to record the number of times per day they had a bowel movement. Complete spontaneous bowel movements per week are reported. Only the 7 days of highest treatment dose will be used for comparison purposes.'}, {'measure': 'Heart Rate Before and After Treatment', 'timeFrame': 'Baseline period (9 days), Treatment period (7 days)', 'description': 'Heart rate is the number of beats per minute, as recording on an Electrocardiogram (ECG).'}, {'measure': 'QTc Interval Before and After Treatment', 'timeFrame': 'Baseline period (9 days), Treatment period (7 days)', 'description': 'The corrected QT interval (QTc) is a measurement of time (seconds) between the Q and T waves of an heart beat as recorded during an Electrocardiogram (ECG).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Constipation', 'Diabetes Mellitus', 'Colonic Transit', 'Gastric Emptying']}, 'referencesModule': {'references': [{'pmid': '22677718', 'type': 'RESULT', 'citation': 'Bharucha AE, Low P, Camilleri M, Veil E, Burton D, Kudva Y, Shah P, Gehrking T, Zinsmeister AR. A randomised controlled study of the effect of cholinesterase inhibition on colon function in patients with diabetes mellitus and constipation. Gut. 2013 May;62(5):708-15. doi: 10.1136/gutjnl-2012-302483. Epub 2012 Jun 7.'}]}, 'descriptionModule': {'briefSummary': 'Doctors at Mayo Clinic are doing this study to learn if pyridostigmine, a drug, affects the speed at which food travels through the stomach, intestines and colon, and if pyridostigmine improves constipation symptoms in patients with diabetes. Pyridostigmine has been approved by the Food and Drug Administration (FDA) for routine clinical use, however, its use as proposed in this study is considered investigational.', 'detailedDescription': 'Chronic constipation in diabetes mellitus is associated with colonic motor dysfunction and is managed with laxatives. Cholinesterase inhibitors increase colonic motility. The study evaluated the effects of a cholinesterase inhibitor (pyridostigmine vs. placebo) on gastrointestinal and colonic transit and bowel function in diabetic patients with constipation.\n\nAfter a 9-day baseline period, patients with diabetes mellitus and chronic constipation without defecatory disorder will be randomized to oral placebo or pyridostigmine, starting with 60 mg three times a day, increasing by 60 mg every third day up to the maximum tolerated dose of 120 mg three times a day; this dose will be maintained for 7 days. Gastrointestinal and colonic transit (assessed by scintigraphy) and bowel function will be evaluated at baseline and the final 3 and 7 days of treatment, respectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with diabetes mellitus (Type I or type II), diagnosed by a physician.\n* On medical treatment for diabetes (oral medication or injected insulin) for at least one year\n* Symptomatic constipation at least 25% of the time in the past year (Rome II criteria for functional constipation)\n* 18-70 years of age\n* Colonoscopy negative for obstructive lesions, cancer, or inflammatory bowel disease (IBS) within the last 8 years if 50 years of age or older\n* Able to provide written informed consent before participating in trial\n* Able to communicate adequately with the Investigator and to comply with the requirements for the entire study\n\nExclusion Criteria:\n\n* History of pelvic floor dysfunction (other functional GI disorders, eg IBS, non-ulcer dyspepsia are acceptable); Specifically, patients will be excluded if they have at least 2 of the following 3 criteria:\n\n * History of digital evacuation of the rectum or pressure on the posterior aspect of the vagina or perineum to facilitate defecation\n * Examination findings suggestive of puborectalis spasm or anismus, on assessment by an experienced gastroenterologist with expertise in this field; i.e. high anal sphincter tone at rest, failure of perineal descent by \\>1cm on straining, and tenderness or paradoxical contraction of the puborectalis on digital examination\n * Requirement of \\> 200g to expel a rectal balloon during voluntary straining\n* Abdominal surgery other than appendectomy, cholecystectomy, hysterectomy, tubal ligation, or inguinal hernia repair\n* Suspected or known gastrointestinal or genitourinary obstruction\n* Uncontrolled hypertension (defined as \\> 150/90 at rest)\n* Known cardiac arrhythmia or ECG abnormalities, i.e. cardiac conduction disturbances (2nd or 3rd degree atrioventricular (AV) block, prolonged corrected QT interval (QTc)(\\> 460 msec) or bradycardia (\\< 45 beats/minute))\n* Renal insufficiency with serum creatinine greater than 2 mg/dl based on a reading from the previous 6 months\n* Asthma or chronic obstructive pulmonary disease requiring systemic steroids in the previous 3 years (inhaled steroids acceptable)\n* Current use of narcotics, gut prokinetic drugs (eg metoclopramide, domperidone, tegaserod, senekot), anticholinergic medication (eg. Hyoscyamine, belladonna), antidiarrheals (Imodium, Lomotil), or laxatives other than fiber supplements, docusate, or glycerin suppositories. Patients on any of these restricted medications must cease use at least 48 hours before starting and for the duration of both study phases. No rescue laxatives will be permitted within 7 days of transit testing\n* Patients who have taken any investigational medications within the past 30 days\n* Known intolerance or allergy to eggs\n* Pregnant or breast-feeding females'}, 'identificationModule': {'nctId': 'NCT00276406', 'briefTitle': 'Use of Pyridostigmine for Constipation in Diabetics', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Pyridostigmine in Diabetics With Constipation: Randomized, Placebo-controlled, Double-blind Trial', 'orgStudyIdInfo': {'id': '05-004037'}, 'secondaryIdInfos': [{'id': 'UL1RR024150-01', 'link': 'https://reporter.nih.gov/quickSearch/UL1RR024150-01', 'type': 'NIH'}, {'id': 'P01DK068055', 'link': 'https://reporter.nih.gov/quickSearch/P01DK068055', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pyridostigmine', 'description': 'Oral pyridostigmine, starting with 60 mg capsules three times per day (TID), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg TID (a total of 360 mg per day). This dose was maintained for 7 days.', 'interventionNames': ['Drug: Pyridostigmine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo (sham) capsules, matching the appearance of the active drug comparator and taken TID.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Pyridostigmine', 'type': 'DRUG', 'otherNames': ['Mestinon'], 'description': 'Pyridostigmine will be started at (60mg) tid, increased over 10 days to 120 mg tid, and maintained at that dose for 7 days.', 'armGroupLabels': ['Pyridostigmine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'If subject is randomized to placebo, placebo pills will be started at (60mg) tid, increased over 10 days to 120 mg tid, and maintained at that dose for 7 days.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Adil E. Bharucha, MBBS, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, {'name': 'National Center for Research Resources (NCRR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Professor of Medicine', 'investigatorFullName': 'Adil Bharucha', 'investigatorAffiliation': 'Mayo Clinic'}}}}