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

Not Applicable

Completed

• Conditions: Type 2 Diabetes

• Registration Number: NCT01579981
• Lead Sponsor: Hvidovre University Hospital

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

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

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-16
• Study First Submitted QC: 2012-04-17
• Study First Posted: 2012-04-18
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-09
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Beta cell glucose sensitivity	1 week and 3 months after RYGB	change in prehepatic insulin secretionrate relative to glucose increments

Secondary Outcome Measures

Name	Time	Method
Glucose tolerance	1 week and 3 months after RYGB	change in AUC glucose
Ad libitum food intake	3 months after surgery	Change in amount of calories ingested

Trial Locations

Locations (1)

Dept. of Endocrinology, Hvidovre Hospital; 🇩🇰 Hvidovre, Denmark