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

This study is currently recruiting participants.

Verified April 2012 by Hvidovre University Hospital

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

History of Changes

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:

MedlinePlus related topics: Diabetes Diabetes Type 2

U.S. FDA Resources

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 May 19, 2013

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