Importance of Meal Fat Content and Gall Bladder Emptying for Postprandial GLP-1 Secretion in Type 2 Diabetes Patients
1 other identifier
observational
30
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 14, 2011
CompletedFirst Posted
Study publicly available on registry
June 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedJanuary 23, 2013
January 1, 2013
1 year
June 14, 2011
January 22, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
GLP-1 secretion
Postprandial
Study Arms (2)
Healthy adults
Type 2 diabetes
Eligibility Criteria
Healthy subjects and type 2 diabetes patients (T2DM)
You may qualify if:
- HbA1 \< 6 %
- Normal haemoglobin levels
- Informed content
- T2DM \> 5 years
- Normal haemoglobin levels
- Informed content
You may not qualify if:
- 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
- st degree relatives with diabetes
- Obesity (BMI \> 30)
- Age \> 70 years
- Gastrointestinal disease
- Nephropathy
- Liver disease
- Medication which cannot be on hold for 12h
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gentofte University Hospital
Hellerup, 2900, Denmark
Related Publications (2)
Sonne DP, van Nierop FS, Kulik W, Soeters MR, Vilsboll T, Knop FK. Postprandial Plasma Concentrations of Individual Bile Acids and FGF-19 in Patients With Type 2 Diabetes. J Clin Endocrinol Metab. 2016 Aug;101(8):3002-9. doi: 10.1210/jc.2016-1607. Epub 2016 Jun 7.
PMID: 27270475DERIVEDSonne DP, Vilsboll T, Knop FK. Pancreatic Amylase and Lipase Plasma Concentrations Are Unaffected by Increments in Endogenous GLP-1 Levels Following Liquid Meal Tests. Diabetes Care. 2015 May;38(5):e71-2. doi: 10.2337/dc14-2751. No abstract available.
PMID: 25908158DERIVED
Biospecimen
blood samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
June 14, 2011
First Posted
June 16, 2011
Study Start
June 1, 2011
Primary Completion
June 1, 2012
Study Completion
November 1, 2012
Last Updated
January 23, 2013
Record last verified: 2013-01