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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014