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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Hvidovre University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Nils Bruun Jørgensen, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01579981
First received: April 16, 2012
Last updated: April 17, 2012
Last verified: April 2012
  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.


Condition Intervention
Type 2 Diabetes
Other: Exendin 9-39 (Bachem, Germany)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Beta cell glucose sensibility in response to a meal [ Time Frame: 3 mo ] [ Designated as safety issue: No ]
    1 week and 3 months after RYGB with and without GLP-1R blockade.

  • Glucose tolerance measured as AUC glucose afer a meal [ Time Frame: 3 mo ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: April 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RYGB
Subjects undergo RYGB.
Other: Exendin 9-39 (Bachem, Germany)
On two separate experimental days before, 1 wk, and 3 mo 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.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01579981

Contacts
Contact: Nils B Jørgensen, MD +45 38623032 nils.bruun.joergensen@hvh.regionh.dk

Locations
Denmark
Dept. of Endocrinology, Hvidovre Hospital Recruiting
Hvidovre, Denmark, DK-2650
Contact: Nils B Jørgensen, MD    +45 38623032    nils.bruun.joergensen@hvh.regionh.dk   
Principal Investigator: Nils B Jørgensen, MD         
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

No publications provided

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: April 17, 2012
Health Authority: Denmark: Datatilsynet
Denmark: Sundhedsstyrelsen

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

ClinicalTrials.gov processed this record on April 16, 2014