Importance of Meal Fat Content and Gall Bladder Emptying for Postprandial GLP-1 Secretion in Type 2 Diabetes Patients

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).

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gentofte University Hospital

Hellerup, 2900, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

GLP-1 secretion

Time frame: Postprandial

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Jun 16, 2011
Registry last updated: Jan 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed