The Role of Metformin and Colesevelam in Human GLP-1 Secretion
Overview[ - collapse ][ - ]
| Purpose | Our primary hypothesis is that bile acid sequestrant colesevelam and the antidiabetic drug metformin potentiates the secretion of the gut hormone glucagon-like peptide 1 (GLP-1). |
|---|---|
| Condition | Type 2 Diabetes |
| Intervention | Drug: Colesevelam Drug: Metformin Other: Placebo |
| Phase | Phase 4 |
| Sponsor | University Hospital, Gentofte, Copenhagen |
| Responsible Party | University Hospital, Gentofte, Copenhagen |
| ClinicalTrials.gov Identifier | NCT02050074 |
| First Received | January 28, 2014 |
| Last Updated | January 29, 2014 |
| Last verified | January 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | January 28, 2014 |
|---|---|
| Last Updated Date | January 29, 2014 |
| Start Date | January 2014 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | Change in the gut hormone glucagon-like peptide 1 (GLP-1) [Time Frame: 0-240 min] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | The Role of Metformin and Colesevelam in Human GLP-1 Secretion |
|---|---|
| Official Title | The Role of Metformin and Colesevelam in Human GLP-1 Secretion |
| Brief Summary | Our primary hypothesis is that bile acid sequestrant colesevelam and the antidiabetic drug metformin potentiates the secretion of the gut hormone glucagon-like peptide 1 (GLP-1). |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science |
| Condition | Type 2 Diabetes |
| Intervention | Drug: Colesevelam Drug: Metformin Other: Placebo |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 12 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | December 2014 |
| Eligibility Criteria | Inclusion Criteria: - Normal hemoglobin - BMI > 23kg/m2 - HbA1c <9 % - Informed concent Exclusion Criteria: - Liver disease ( aspartate aminotransferase/alanine aminotransferase >2 × reference value) - Chronic intestinal disease - History of liver and / or gallbladder disease - Nephropathy (se-creatinine >110 µM and / or albuminuria) - Insulin or GLP-1-based antidiabetic treatment - History of cholecystectomy or surgical resection of bowel segment - BMI <23kg/m2 or BMI >35 kg/m2 - Pregnancy |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Denmark |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT02050074 |
|---|---|
| Other Study ID Numbers | H-1-2013-010 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | University Hospital, Gentofte, Copenhagen |
| Study Sponsor | University Hospital, Gentofte, Copenhagen |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Verification Date | January 2014 |
Locations[ + expand ][ + ]
| Diabetes Research Division, Department of Medicine, Gentofte Hospital | Hellerup, Copenhagen, Denmark, 2900 Contact: Morten Hansen, Dr. | +45 3977 2691 | morten.hansen.02@regionh.dkPrincipal Investigator: Morten Hansen, Dr. Recruiting |
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