Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2026-02-28 @ 9:11 PM
Study NCT ID:
NCT01914133
Status:
COMPLETED
Last Update Posted:
2021-05-28
First Post:
2013-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acarbose and Older Adults With Postprandial Hypotension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013575', 'term': 'Syncope'}], 'ancestors': [{'id': 'D014474', 'term': 'Unconsciousness'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020909', 'term': 'Acarbose'}, {'id': 'D065089', 'term': 'Glycoside Hydrolase Inhibitors'}], 'ancestors': [{'id': 'D014312', 'term': 'Trisaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D007004', 'term': 'Hypoglycemic Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-26', 'studyFirstSubmitDate': '2013-07-22', 'studyFirstSubmitQcDate': '2013-07-30', 'lastUpdatePostDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'ambulatory blood pressure monitoring (Welch-Allyn, Ambulatory Blood Pressure Monitor(ABPM) 6100S) performed for 24 hours', 'timeFrame': '1 day', 'description': 'Starting the day following each meal test, each subject with PPH will take either acarbose 25 mg po tid (prior to each meal) or placebo po tid for one day. During this 24 hour period, each subject will undergo 24 Hr-ABPM (starting at 7 ante meridian (AM) the following day). Each subject will have ambulatory blood pressure monitoring (Welch-Allyn, ABPM 6100S) performed for 24 hours. Each subject will carry a logbook to record time of activity and all meals. Each subject will be given a watch synchronized to the 24-hour blood pressure monitor.'}], 'primaryOutcomes': [{'measure': 'The postprandial cardiovascular response to a standardized meal compared between subjects with and without PPH', 'timeFrame': '2 years', 'description': 'The postprandial cardiovascular response (mesenteric blood flow, adrenergic response, cerebral blood flow) to a standardized meal will be compared between n=30 subjects with PPH and n= 30 subjects without PPH.'}], 'secondaryOutcomes': [{'measure': 'The postprandial glucagon-like peptide-1 (GLP-1) and gastric inhibitory peptide (GIP) response to a standardized meal compared between subjects with and without PPH', 'timeFrame': '2 years', 'description': 'The postprandial GLP-1 and GIP response to a standardized meal compared between subjects with and without PPH'}, {'measure': 'The postprandial cardiovascular response between the Acarbose group and the Placebo group will be compared.', 'timeFrame': '2.5 years', 'description': 'The postprandial cardiovascular response (mesenteric blood flow, adrenergic response, cerebral blood flow) to a standardized meal between the Acarbose group and the Placebo group will be compared.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acarbose', 'PPH (Post Prandial Hypotension)', 'Falls', 'Syncope', 'Elderly'], 'conditions': ['Other Specified Hypotension', 'Syncope']}, 'referencesModule': {'references': [{'pmid': '40719030', 'type': 'DERIVED', 'citation': 'Madden KM, Feldman B, Meneilly GS. The Effects of Acarbose on the Postprandial Hypotensive Response in Older Adults. Can J Aging. 2025 Sep;44(3):370-376. doi: 10.1017/S0714980825100056.'}]}, 'descriptionModule': {'briefSummary': 'The current proposal will determine if blocking carbohydrate intake in the small intestine with Acarbose can be a possible therapy for older adults with (PPH) Post Prandial Hypotension (a drop of blood pressure after eating), which can result in falls.', 'detailedDescription': 'Blocking the absorption of carbohydrates at the brush border of the small intestine with acarbose (an alpha-glucosidase inhibitor) seems a promising possibility as a potential therapeutic agent. Although designed as a second-line diabetes drug, this medication has very little risk of hypoglycemia in older adults. In fact the risk of hypoglycemia is extremely low even in patients concurrently taking concurrent hypoglycemia agents (including insulin), and there is almost no risk of hypoglycemia in subjects not on other diabetes medications. Acarbose suppresses postprandial glycemia by slowing small intestinal digestion and absorption of carbohydrate, and has been shown to slow gastric emptying Acarbose has yet to be examined in a prospective fashion in older adults, despite the prevalence of PPH in this patient population. Preliminary, pilot work done in our laboratory on older adults with PPH has demonstrated that the hypotensive response over 90 minutes to a standardized meal was significantly reduced by the administration of acarbose'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* be 65 years of age or older,\n* be a non-smoker for at least 5 years\n* be referred to the falls clinic at Vancouver General Hospital\n* have a Folstein test of cognition \\> 25/30 to ensure meal log-book compliance\n\nExclusion Criteria:\n\n* no oral or swallowing issues that would prevent a Meal Test\n* subject requiring dialysis due to end-stage renal failure will be excluded\n* subjects with evidence on history, physical or blood work of hepatic disease will be excluded since elevated serum transaminases are a potential adverse effect of acarbose\n* cannot currently be taking an alpha-glucosidase inhibitor\n* cannot have had allergic reactions to alpha-glucosidase inhibitors in the past\n* Due to the fact that acarbose is renally excreted, all subjects must have a Creatine Clearance of greater than 25 ml/min\n* Subjects with a past history of inflammatory bowel disease, intestinal obstruction, ileus and peptic ulcer disease will be excluded\n* Subjects taking carbohydrate-splitting enzymes (such as amylase) will be excluded\n* Subjects with chronic respiratory issues requiring treatment will be excluded'}, 'identificationModule': {'nctId': 'NCT01914133', 'acronym': 'PPH', 'briefTitle': 'Acarbose and Older Adults With Postprandial Hypotension', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Acarbose and Older Adults With Postprandial Hypotension', 'orgStudyIdInfo': {'id': 'H13-01316'}, 'secondaryIdInfos': [{'id': 'G-13-0001812', 'type': 'OTHER_GRANT', 'domain': 'The Heart and Stroke Foundation of Canada (the Foundation)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No Postprandial Hypotension (PPH)', 'description': 'Screening Meal Test performed and subject does not meet criteria for Postprandial Hypotension (PPH).'}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Screening Meal Test performed and subject meets criteria for Postprandial Hypotension (PPH). At second Meal Test subject will receive a placebo and will take a placebo with the first bite of the next 3 meals.', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Acarbose', 'description': 'Screening Meal Test performed and subject meets criteria for Postprandial Hypotension. During the second Meal Test subject will receive Acarbose 50mg and will take Acarbose 25mg with first bite of each of the next 3 meals.', 'interventionNames': ['Drug: Acarbose']}], 'interventions': [{'name': 'Acarbose', 'type': 'DRUG', 'otherNames': ['Glucobay', 'Precose', 'Prandase', 'Alpha-glucosidase inhibitor'], 'description': 'Acarbose 50 mg given during Meal Test and Acarbose 25 mg taken with first bite of the next 3 meals.', 'armGroupLabels': ['Acarbose']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Bayer Material No: 02839265', 'Acarbose Placebo Tablet'], 'description': 'Placebo given prior to meal the standardized meal', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z 1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Vancouver Coastal Health Research Institute, VGH Research Pavilion Room 186', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Kenneth M Madden, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kenneth Madden', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Division Head, VGH Division of Geriatric Medicine', 'investigatorFullName': 'Kenneth Madden', 'investigatorAffiliation': 'University of British Columbia'}}}}