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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nils Bruun Jørgensen, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01579981
First received: April 16, 2012
Last updated: February 9, 2017
Last verified: February 2017
  Purpose
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

Condition Intervention
Type 2 Diabetes
Procedure: Roux-en-Y Gastric Bypass

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Participant
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Beta cell glucose sensitivity [ Time Frame: 1 week and 3 months after RYGB ]
    change in prehepatic insulin secretionrate relative to glucose increments


Secondary Outcome Measures:
  • Glucose tolerance [ Time Frame: 1 week and 3 months after RYGB ]
    change in AUC glucose

  • Ad libitum food intake [ Time Frame: 3 months after surgery ]
    Change in amount of calories ingested


Enrollment: 9
Study Start Date: April 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Roux-en-Y Gastric Bypass
    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.
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
  Eligibility

Ages Eligible for Study:   25 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01579981

Locations
Denmark
Dept. of Endocrinology, Hvidovre Hospital
Hvidovre, Denmark, DK-2650
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
Study Chair: Sten Madsbad, MD, DMSc Dept. of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark
Principal Investigator: Nils B Jørgensen, MD Dept. of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nils Bruun Jørgensen, Klinisk Assistent, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01579981     History of Changes
Other Study ID Numbers: H-A-2008-080-31742 
Study First Received: April 16, 2012
Last Updated: February 9, 2017

Keywords provided by Hvidovre University Hospital:
RYGB
Bariatric Surgery
Glucagon-like-peptide 1

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glucagon
Glucagon-Like Peptide 1
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins

ClinicalTrials.gov processed this record on February 24, 2017