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

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ClinicalTrials.gov Identifier: NCT01579981
Recruitment Status : Completed
First Posted : April 18, 2012
Last Update Posted : February 10, 2017
Sponsor:
Information provided by (Responsible Party):
Nils Bruun Jørgensen, 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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Procedure: Roux-en-Y Gastric Bypass Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: Single (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
Study Start Date : April 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Glucagon
U.S. FDA Resources


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.


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

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



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: April 18, 2012    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017

Keywords provided by Nils Bruun Jørgensen, 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