Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2026-03-05 @ 6:45 PM
Study NCT ID:
NCT00501657
Status:
COMPLETED
Last Update Posted:
2015-10-29
First Post:
2007-07-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Sitagliptin on Gastric Emptying in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018589', 'term': 'Gastroparesis'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'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': 'D000068900', 'term': 'Sitagliptin Phosphate'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-27', 'studyFirstSubmitDate': '2007-07-13', 'studyFirstSubmitQcDate': '2007-07-13', 'lastUpdatePostDateStruct': {'date': '2015-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastric emptying rate', 'timeFrame': '4 hours per study'}], 'secondaryOutcomes': [{'measure': 'Intragastric distribution, gastrointestinal hormone release (GLP-1, GIP), glycemia, insulinemia, appetite', 'timeFrame': '4 hours per study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['gastric emptying', 'glycemia', 'appetite', 'incretin hormones'], 'conditions': ['Gastroparesis', 'Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '22738299', 'type': 'DERIVED', 'citation': 'Stevens JE, Horowitz M, Deacon CF, Nauck M, Rayner CK, Jones KL. The effects of sitagliptin on gastric emptying in healthy humans - a randomised, controlled study. Aliment Pharmacol Ther. 2012 Aug;36(4):379-90. doi: 10.1111/j.1365-2036.2012.05198.x. Epub 2012 Jun 28.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/22738299', 'label': 'Pubmed abstract'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effects of the drug, sitagliptin, on the rate at which the stomach empties, and the release of gut hormones and blood glucose concentrations, after a mashed potato meal in healthy subjects. Sitagliptin has been shown to reduce the blood glucose (sugar) response to a meal and this may potentially be due to slowing of stomach emptying. This is particularly relevant to people who have diabetes, in whom normalization of elevated blood glucose levels is important to maintain health.', 'detailedDescription': 'The purpose of this study is to evaluate the effect of sitagliptin on gastric emptying, intragastric meal distribution, postprandial glycemia and insulinemia in healthy subjects. Glucagon-like peptide-1 (GLP-1) inhibits gastric emptying, thereby slowing the delivery of nutrients, and their absorption, across the small intestine. The rate of entry of carbohydrate into the small intestine is especially important in patients with diabetes mellitus. Sitagliptin is an orally administered inhibitor of dipeptidyl-peptidase-IV (DPP-IV), the enzyme responsible for the degradation of GLP-1. It is hypothesized that sitagliptin will increase the GLP-1 response to, and thereby slow gastric emptying and diminish the glycemic response to, a carbohydrate-containing meal.\n\nFifteen healthy subjects (male and female) will be studied. Each subject will be studied on two occasions following treatment for 2 days with sitagliptin (100mg once daily) or matching placebo in a randomized, double blind, crossover design. Measurements of gastric emptying, intragastric meal distribution, blood glucose concentrations, gut hormones and appetite will be measured for 4 hours following ingestion of a mashed potato meal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female (females must be using an appropriate contraceptive method)\n* 18 - 45 years\n* Body mass index (BMI) 19 - 25 kg/m2.\n\nExclusion criteria:\n\n* Subjects with gastrointestinal disease, history of gastrointestinal surgery and/or significant gastrointestinal symptoms\n* Subjects taking medication known to influence gastrointestinal function\n* Alcohol intake \\> 20 g per day\n* Smoking \\> 10 cigarettes per day\n* Pregnant and/or lactating females\n* Calculated creatinine clearance \\< 60 ml/min\n* Exposure to ionising radiation for research purposes in the previous 12 months.'}, 'identificationModule': {'nctId': 'NCT00501657', 'briefTitle': 'Effects of Sitagliptin on Gastric Emptying in Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Royal Adelaide Hospital'}, 'officialTitle': 'Effects of Sitagliptin on Gastric Emptying in Healthy Subjects', 'orgStudyIdInfo': {'id': '061025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sitagliptin (100mg)', 'description': 'Active drug (sitagliptin)', 'interventionNames': ['Drug: Sitagliptin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (sugar pill)', 'description': 'Inactive drug (placebo)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Sitagliptin', 'type': 'DRUG', 'otherNames': ['MK-0431-075', 'Januvia'], 'description': '100mg mane for 2 days', 'armGroupLabels': ['Sitagliptin (100mg)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '100mg mane for 2 days', 'armGroupLabels': ['Placebo (sugar pill)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Discipline of Medicine, Royal Adelaide Hospital', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}], 'overallOfficials': [{'name': 'Karen L Jones, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Adelaide, Royal Adelaide Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Adelaide Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Karen Jones', 'investigatorAffiliation': 'Royal Adelaide Hospital'}}}}