Importance of Meal Fat Content and Gall Bladder Emptying for Postprandial GLP-1 Secretion in Type 2 Diabetes Patients
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ClinicalTrials.gov Identifier: NCT01374594 |
Recruitment Status
:
Completed
First Posted
: June 16, 2011
Last Update Posted
: January 23, 2013
|
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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 or disease |
---|
Diabetes |
Study Type : | Observational |
Actual Enrollment : | 30 participants |
Study Start Date : | June 2011 |
Actual Primary Completion Date : | June 2012 |
Actual Study Completion Date : | November 2012 |

Group/Cohort |
---|
Healthy adults |
Type 2 diabetes |
- GLP-1 secretion [ Time Frame: Postprandial ]
Biospecimen Description:

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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 |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01374594
Denmark | |
Gentofte University Hospital | |
Hellerup, Denmark, 2900 |
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 |
First Posted: | June 16, 2011 Key Record Dates |
Last Update Posted: | January 23, 2013 |
Last Verified: | January 2013 |