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

NCT ID: NCT01374594

Last Updated: 2013-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-11-30

Brief Summary

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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).

Detailed Description

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Conditions

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Diabetes

Study Groups

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Healthy adults

No interventions assigned to this group

Type 2 diabetes

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* HbA1 \< 6 %
* Normal haemoglobin levels
* Informed content


* T2DM \> 5 years
* Normal haemoglobin levels
* Informed content

Exclusion Criteria

* 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


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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David P. Sonne

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gentofte University Hospital

Hellerup, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 27270475 (View on PubMed)

Sonne 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.

Reference Type DERIVED
PMID: 25908158 (View on PubMed)

Other Identifiers

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GAL-INK II

Identifier Type: -

Identifier Source: org_study_id

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