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Importance of Meal Fat Content and Gall Bladder Emptying for Postprandial GLP-1 Secretion in Type 2 Diabetes Patients
This study has been completed.
Sponsor:
University Hospital, Gentofte, Copenhagen
Information provided by (Responsible Party):
David P. Sonne, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT01374594
First received: June 14, 2011
Last updated: January 22, 2013
Last verified: January 2013
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Purpose
PURPOSE
The goal of the present project is to unravel the importance of bile acid-induced GLP-1 secretion (via the G protein-coupled receptor TGR5) in human physiology.
In the present study the investigators examine the GLP-1 secretion in healthy subjects and in Type 2 Diabetes Mellitus (T2DM) patients. The investigators hypothesize that patients with T2DM of relatively long duration will be characterized by reduced gall bladder emptying, and, consequently, reduced intestinal TGR5 activation; resulting in attenuated postprandial GLP-1 responses (primary endpoint).
| Condition |
|---|
| Diabetes |
| Study Type: | Observational |
Further study details as provided by David P. Sonne, University Hospital, Gentofte, Copenhagen:
Primary Outcome Measures:
- GLP-1 secretion [ Time Frame: Postprandial ]
Biospecimen Description:
blood samples
| Enrollment: | 30 |
| Study Start Date: | June 2011 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Healthy adults |
| Type 2 diabetes |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Healthy subjects and type 2 diabetes patients (T2DM)
Criteria
Inclusion Criteria: (Healthy)
- HbA1 < 6 %
- Normal haemoglobin levels
- Informed content
Inclusion Criteria: (T2DM)
- T2DM > 5 years
- Normal haemoglobin levels
- Informed content
Exclusion Criteria: (T2DM)
- Treatment with insulin, DPP-IV inhibitor or GLP-1 analogues
- Obesity (BMI > 30)
- Age > 70 years
- Gastrointestinal disease
- Nephropathy
- Liver disease
- Medication which cannot be on hold for 12h
- Gastrointestinal surgery
Exclusion Criteria: (Healthy)
- 1st degree relatives with diabetes
- Obesity (BMI > 30)
- Age > 70 years
- Gastrointestinal disease
- Nephropathy
- Liver disease
- Medication which cannot be on hold for 12h
- Gastrointestinal surgery
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01374594
Please refer to this study by its ClinicalTrials.gov identifier: NCT01374594
Locations
| Denmark | |
| Gentofte University Hospital | |
| Hellerup, Denmark, 2900 | |
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | David P. Sonne, MD, University Hospital, Gentofte, Copenhagen |
| ClinicalTrials.gov Identifier: | NCT01374594 History of Changes |
| Other Study ID Numbers: |
GAL-INK II |
| Study First Received: | June 14, 2011 |
| Last Updated: | January 22, 2013 |
ClinicalTrials.gov processed this record on June 28, 2017