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The Importance of GLP-1 in Post RYGB Improvement in Glycaemic Control Type 2 Diabetic Subjects

Primary Purpose

Type 2 Diabetes

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Roux-en-Y Gastric Bypass

About this trial

This is an interventional basic science trial for Type 2 Diabetes focused on measuring RYGB, Bariatric Surgery, Glucagon-like-peptide 1

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Fasting glucose > 7.0 mM, 2h glucose after OGTT > 11.0 mM. BMI > 35. HbA1c < 8.5%. Fasting C-peptide > 700 pM. Elegible for RYGB.

Exclusion Criteria:

Dysregulated hypothyroidism, hyperthyroidism, anaemia.

Sites / Locations

Dept. of Endocrinology, Hvidovre Hospital

Outcomes

Primary Outcome Measures

Beta cell glucose sensitivity

change in prehepatic insulin secretionrate relative to glucose increments

Secondary Outcome Measures

Glucose tolerance

change in AUC glucose

Ad libitum food intake

Change in amount of calories ingested

Full Information

NCT ID

NCT01579981

First Posted

April 16, 2012

Last Updated

February 9, 2017

Sponsor

Hvidovre University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01579981

Brief Title

The Importance of GLP-1 in Post RYGB Improvement in Glycaemic Control Type 2 Diabetic Subjects

Official Title

The Exaggerated Glucagon-like Peptide-1 Response is Important for the Improved β-cell Function and Glucose Tolerance After Roux-en-Y Gastric Bypass in Patients With Type 2 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

April 2012 (undefined)

Primary Completion Date

November 2012 (Actual)

Study Completion Date

November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hvidovre University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

After Roux-en-Y gastric bypass (RYGB) meal induced GLP-1 secretion is dramatically increased, while beta-cell function is increased in type 2 diabetic (T2D) subjects. The aim of this study is to establish causality between the two observations. By meal testing 10 T2D subjects with infusion of saline or exendin (9-39), a GLP-1R specific blocker, before and 1 week and 3 months after RYGB we hope to demonstrate the role of GLP-1 in improveing beta-cell function and maintaing glucose tolerance after RYGB in T2D subjects. Furthermore, effects of GLP-1 rec blockade before and after RYGB on ad libitum energy intake is examined

Detailed Description

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes

Keywords

RYGB, Bariatric Surgery, Glucagon-like-peptide 1

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

N/A

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Roux-en-Y Gastric Bypass

Intervention Description

On two separate experimental days before, 1 wk, and 3 months after RYGB, subjects are given a liquid meal test during Exendin 9-39 (900 pmol/min/kg)or saline infusion. The order of the infusions is randomized. At end of study day an ad libitum meal is served.

Primary Outcome Measure Information:

Title

Beta cell glucose sensitivity

Description

change in prehepatic insulin secretionrate relative to glucose increments

Time Frame

1 week and 3 months after RYGB

Secondary Outcome Measure Information:

Title

Glucose tolerance

Description

change in AUC glucose

Time Frame

1 week and 3 months after RYGB

Title

Ad libitum food intake

Description

Change in amount of calories ingested

Time Frame

3 months after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Fasting glucose > 7.0 mM, 2h glucose after OGTT > 11.0 mM. BMI > 35. HbA1c < 8.5%. Fasting C-peptide > 700 pM. Elegible for RYGB. Exclusion Criteria: Dysregulated hypothyroidism, hyperthyroidism, anaemia.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sten Madsbad, MD, DMSc

Organizational Affiliation

Dept. of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Nils B Jørgensen, MD

Organizational Affiliation

Dept. of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dept. of Endocrinology, Hvidovre Hospital

City

Hvidovre

ZIP/Postal Code

DK-2650

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

27306058

Citation

Palleja A, Kashani A, Allin KH, Nielsen T, Zhang C, Li Y, Brach T, Liang S, Feng Q, Jorgensen NB, Bojsen-Moller KN, Dirksen C, Burgdorf KS, Holst JJ, Madsbad S, Wang J, Pedersen O, Hansen T, Arumugam M. Roux-en-Y gastric bypass surgery of morbidly obese patients induces swift and persistent changes of the individual gut microbiota. Genome Med. 2016 Jun 15;8(1):67. doi: 10.1186/s13073-016-0312-1.

Results Reference

derived

PubMed Identifier

25763111

Citation

Lindegaard KK, Jorgensen NB, Just R, Heegaard PM, Madsbad S. Effects of Roux-en-Y gastric bypass on fasting and postprandial inflammation-related parameters in obese subjects with normal glucose tolerance and in obese subjects with type 2 diabetes. Diabetol Metab Syndr. 2015 Feb 24;7:12. doi: 10.1186/s13098-015-0012-9. eCollection 2015.

Results Reference

derived

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The Importance of GLP-1 in Post RYGB Improvement in Glycaemic Control Type 2 Diabetic Subjects

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