Importance of Meal Fat Content and Gall Bladder Emptying... | NCT01374594

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

NCT01374594

Sponsor

University Hospital, Gentofte, Copenhagen

Status

Completed

Last Update Posted

Jan 23, 2013Estimated

Enrollment

30Actual

Phase

Not provided

Conditions

Diabetes

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Jun 2012Actual

Completion Date

Nov 2012Actual

First Submitted Date

Jun 14, 2011

First Submission Date that Met QC Criteria

Jun 15, 2011

First Posted Date

Jun 16, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 22, 2013

Last Update Posted Date

Jan 23, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

David P. Sonne, MD, University Hospital, Gentofte, CopenhagenPrincipal Investigator

Lead Sponsor

University Hospital, Gentofte, CopenhagenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

Retention

Not provided

Description

Enrollment

30Actual

Measure	Description	Time Frame
GLP-1 secretion		Postprandial

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Healthy subjects and type 2 diabetes patients (T2DM)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gentofte University Hospital		Hellerup		2900	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27270475	Derived	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.
25908158	Derived	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.

Label	Type	Description	Intervention Names
Healthy adults
Type 2 diabetes

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases