Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-31 @ 2:08 AM
Study NCT ID:
NCT01207934
Status:
COMPLETED
Last Update Posted:
2015-07-09
First Post:
2010-09-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Recombinant Human Leptin Therapy Effects on Insulin Action
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020738', 'term': 'Leptin'}], 'ancestors': [{'id': 'D054392', 'term': 'Adipokines'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sklein@wustl.edu', 'phone': '3143628708', 'title': 'Samuel Klein, MD', 'organization': 'Washington University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'saline placebo for fourteen days', 'otherNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Low-dose Leptin', 'description': '30mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days', 'otherNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'High-dose Leptin', 'description': '80mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days', 'otherNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Baseline Glucose Disposal - a Measure of the Body's Ability to Process Sugars.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '14 days on placebo (saline)'}, {'id': 'OG001', 'title': 'Low Dose Leptin', 'description': '30mg leptin daily for fourteen days'}, {'id': 'OG002', 'title': 'High Dose Leptin', 'description': '80mg leptin daily for fourteen days'}], 'classes': [{'categories': [{'measurements': [{'value': '14.3', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '18.4', 'spread': '3.6', 'groupId': 'OG001'}, {'value': '16.7', 'spread': '2.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'pre-treatment glucose disposal. In general, a high glucose disposal rate is a marker of healthy metabolic function. Glucose disposal is measured by tracking the amount of tagged glucose in the bloodstream over time. It is adjusted to subject body weight.', 'unitOfMeasure': 'mmol/kg body weight/minute', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2011-06'}, {'type': 'SECONDARY', 'title': 'Baseline Plasma Leptin Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '14 days on placebo (saline)'}, {'id': 'OG001', 'title': 'Low Dose Leptin', 'description': '30mg leptin daily for fourteen days'}, {'id': 'OG002', 'title': 'High Dose Leptin', 'description': '80mg leptin daily for fourteen days'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'spread': '7', 'groupId': 'OG000'}, {'value': '24', 'spread': '8', 'groupId': 'OG001'}, {'value': '35', 'spread': '10', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'Leptin is an endogenous hormone. Here we measure the pre-treatment concentration of naturally-occurring leptin in the blood.', 'unitOfMeasure': 'Micrograms/Liter', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2011-06'}, {'type': 'PRIMARY', 'title': 'Post-treatment Glucose Disposal. I.e. Glucose Disposal After Treatment With Leptin or Placebo.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '14 days on placebo (saline)'}, {'id': 'OG001', 'title': 'Low Dose Leptin', 'description': '30mg leptin daily for fourteen days'}, {'id': 'OG002', 'title': 'High Dose Leptin', 'description': '80mg leptin daily for fourteen days'}], 'classes': [{'categories': [{'measurements': [{'value': '17.5', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '20.7', 'spread': '3.0', 'groupId': 'OG001'}, {'value': '19.1', 'spread': '3.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'ANOVA for reapeated measures was used to compare the three groups.', 'groupDescription': 'The null hypothesis was that there would be no change in glucose disposal between the three groups (placebo, low dose leptin, and high dose leptin). Power calculations were done showing that 6 subjects in each arm was enough to detect a 35% between group difference in glucose disposal at the 0.05 level with 80% power.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'fourteen days', 'description': "This is a measure of the body's ability to metabolize sugar after treatment with either leptin or a placebo. We compare the effect of leptin therapy on insulin-mediated stimulation of glucose disposal with that of placebo. In general, a high glucose disposal rate is a marker of healthy metabolic function. Glucose disposal is measured by tracking the amount of tagged glucose in the bloodstream over time. It is adjusted to subject body weight.", 'unitOfMeasure': 'mmol/kg body weight/minute', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2011-05'}, {'type': 'SECONDARY', 'title': 'Post-treatment Plasma Leptin Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '14 days on placebo (saline)'}, {'id': 'OG001', 'title': 'Low Dose Leptin', 'description': '30mg leptin daily for fourteen days'}, {'id': 'OG002', 'title': 'High Dose Leptin', 'description': '80mg leptin daily for fourteen days'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'spread': '5', 'groupId': 'OG000'}, {'value': '76', 'spread': '19', 'groupId': 'OG001'}, {'value': '5024', 'spread': '500', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'a priori threshold for significance was set at p = 0.05.', 'groupDescription': 'The null hypothesis is that treatment would not effect plasma leptin levels.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'T-tests compared pre and post-treatment values.', 'testedNonInferiority': False}, {'pValue': '<0.01', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'a priori threshold for significance was p = 0.05.', 'groupDescription': 'null hypothesis was that plasma leptin levels would be equal after treatment in the placebo and high-dose leptin groups.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'fourteen days', 'description': 'plasma leptin levels after fourteen days ingestion of either leptin or placebo.', 'unitOfMeasure': 'Micrograms/Liter', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2011-06'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'saline placebo for fourteen days'}, {'id': 'FG001', 'title': 'Low-dose Leptin', 'description': '30mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days'}, {'id': 'FG002', 'title': 'High-dose Leptin', 'description': '80mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited from August 1998 to August 1999. All subjects were recruited via the Volunteer for Health system at Washington University School of Medicine.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'saline placebo for fourteen days'}, {'id': 'BG001', 'title': 'Low-dose Leptin', 'description': '30mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days'}, {'id': 'BG002', 'title': 'High-dose Leptin', 'description': '80mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60', 'spread': '1.2', 'groupId': 'BG000'}, {'value': '53', 'spread': '2.9', 'groupId': 'BG001'}, {'value': '54', 'spread': '1.6', 'groupId': 'BG002'}, {'value': '56', 'spread': '1.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2000-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-11', 'studyFirstSubmitDate': '2010-09-21', 'resultsFirstSubmitDate': '2011-06-06', 'studyFirstSubmitQcDate': '2010-09-22', 'lastUpdatePostDateStruct': {'date': '2015-07-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-07-13', 'studyFirstPostDateStruct': {'date': '2010-09-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2000-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Baseline Glucose Disposal - a Measure of the Body's Ability to Process Sugars.", 'timeFrame': 'baseline', 'description': 'pre-treatment glucose disposal. In general, a high glucose disposal rate is a marker of healthy metabolic function. Glucose disposal is measured by tracking the amount of tagged glucose in the bloodstream over time. It is adjusted to subject body weight.'}, {'measure': 'Post-treatment Glucose Disposal. I.e. Glucose Disposal After Treatment With Leptin or Placebo.', 'timeFrame': 'fourteen days', 'description': "This is a measure of the body's ability to metabolize sugar after treatment with either leptin or a placebo. We compare the effect of leptin therapy on insulin-mediated stimulation of glucose disposal with that of placebo. In general, a high glucose disposal rate is a marker of healthy metabolic function. Glucose disposal is measured by tracking the amount of tagged glucose in the bloodstream over time. It is adjusted to subject body weight."}], 'secondaryOutcomes': [{'measure': 'Baseline Plasma Leptin Concentrations', 'timeFrame': 'baseline', 'description': 'Leptin is an endogenous hormone. Here we measure the pre-treatment concentration of naturally-occurring leptin in the blood.'}, {'measure': 'Post-treatment Plasma Leptin Levels', 'timeFrame': 'fourteen days', 'description': 'plasma leptin levels after fourteen days ingestion of either leptin or placebo.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['diabetes', 'obesity'], 'conditions': ['Type Two Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '21411512', 'type': 'DERIVED', 'citation': 'Mittendorfer B, Horowitz JF, DePaoli AM, McCamish MA, Patterson BW, Klein S. Recombinant human leptin treatment does not improve insulin action in obese subjects with type 2 diabetes. Diabetes. 2011 May;60(5):1474-7. doi: 10.2337/db10-1302. Epub 2011 Mar 16.'}]}, 'descriptionModule': {'briefSummary': 'Leptin therapy improves insulin sensitivity in people with leptin-deficiency but it is not known whether it improves insulin action in persons who are not leptin deficient. The purpose of the present study was to determine whether leptin therapy has effects on insulin action in obese subjects with type 2 diabetes mellitus (T2DM). A randomized, placebo controlled trial was conducted in obese subjects with newly-diagnosed T2DM. Subjects were randomized to treatment with placebo, low-dose, or high-dose leptin. Insulin sensitivity was measured.', 'detailedDescription': 'Leptin therapy improves insulin sensitivity in people with leptin-deficiency but it is not known whether it improves insulin action in persons who are not leptin deficient. The purpose of the present study was to determine whether leptin therapy has weight loss-independent effects on insulin action in obese subjects with type 2 diabetes mellitus (T2DM). A randomized, placebo controlled trial was conducted in obese subjects with newly-diagnosed T2DM. Subjects were randomized to treatment with placebo (saline), low-dose (30 mg/d), or high-dose (80 mg/d) recombinant methionyl human (r-met hu) leptin for 14 days. Multi-organ insulin sensitivity before and after treatment was evaluated by using the hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotopically labelled tracer infusions to measure glucose, glycerol and fatty acid kinetics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed with type 2 diabetes for less than ten years\n* Body mass index 25 - 40\n* hemoglobin A1C 7.5% - 12.0%\n* fasting blood glucose between 90 and 240mg/dL\n\nExclusion Criteria:\n\n* smoking\n* pregnancy\n* diabetes medications\n* regular exercise (more than 3 hours per week)\n* uncontrolled hypertension: systolic blood pressure greater than 160 or diastolic blood pressure greater than 95'}, 'identificationModule': {'nctId': 'NCT01207934', 'acronym': 'Leptin', 'briefTitle': 'Recombinant Human Leptin Therapy Effects on Insulin Action', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Recombinant Human Leptin Therapy Effects on Insulin Action', 'orgStudyIdInfo': {'id': '98-0643'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'saline placebo for fourteen days', 'interventionNames': ['Dietary Supplement: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'low-dose leptin', 'description': '30mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days', 'interventionNames': ['Drug: low-dose leptin']}, {'type': 'EXPERIMENTAL', 'label': 'high-dose leptin', 'description': '80mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days', 'interventionNames': ['Drug: high-dose leptin']}], 'interventions': [{'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'saline placebo', 'armGroupLabels': ['placebo']}, {'name': 'low-dose leptin', 'type': 'DRUG', 'description': '30mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days', 'armGroupLabels': ['low-dose leptin']}, {'name': 'high-dose leptin', 'type': 'DRUG', 'description': '80mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days', 'armGroupLabels': ['high-dose leptin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Amgen', 'class': 'INDUSTRY'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}