The Effect of Roux-en-Y Gastric Bypass on Mitochondrial Function in Type 2 Diabetes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Hvidovre University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Anna Kirstine Bojsen-Moeller, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01468116
First received: November 7, 2011
Last updated: NA
Last verified: November 2011
History: No changes posted
  Purpose

Roux-en-Y gastric bypass (RYGB) surgery induces resolution of type 2 diabetes, often within days after surgery and before significant weight loss. The aim of this study is to investigate whether changes in mitochondrial function contributes to the early improvement of type 2 diabetes after RYGB.


Condition
Type 2 Diabetes
Obesity

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Biospecimen Retention:   Samples Without DNA

serum, plasma


Estimated Enrollment: 30
Study Start Date: March 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
RYGB patients with type 2 diabetes
Morbidly obese patients with type 2 diabetes undergoing gastric bypass surgery
RYGB patients without type 2 diabetes
Morbidly obese patients with normal glucose tolerance undergoing gastric bypass surgery
Cholecystectomy patients without type 2 diabetes
Patients with normal glucose tolerance undergoing laparoscopically cholecystectomy

Detailed Description:

Mitochondrial dysfunction has been linked to development of insulin resistance in the muscle and hence to the pathogenesis of type 2 diabetes. Mitochondrial function can be studied non-invasively by 31 Phosphor Magnetic Resonance spectroscopy (31PMRS). In this study we will investigate changes in mitochondrial function using the combination of 31 PMRS and Near Infra-Red Spectroscopy (NIRS) after gastric bypass.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects are recruited from the outpatient clinic of endocrinology and the gastrosurgical clinic at Hvidovre University Hospital

Criteria

Inclusion Criteria:

  • Patients eligible for gastric bypass surgery or cholecystectomy
  • Verified type 2 diabetes or normal glucose tolerance by OGTT

Exclusion Criteria:

  • Patients unable to fit the dimensions of the MRI-scanner
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01468116

Contacts
Contact: Kirstine Nyvold Bojsen-Møller, MD +4538626371 kirstine.bojsen-moeller@hvh.regionh.dk
Contact: Sten Madsbad, professor, MD +4538622291 sten.madsbad@hvh.regionh.dk

Locations
Denmark
Hvidovre University Hospital Recruiting
Copenhagen, Hvidovre, Denmark, DK-2650
Contact: Kirstine Nyvold Bojsen-Møller, MD    +4538626371    kirstine.bojsen-moeller@hvh.regionh.dk   
Principal Investigator: Kirstine Nyvold Bojsen-Møller, MD         
Sponsors and Collaborators
Hvidovre University Hospital
University of Copenhagen
  More Information

No publications provided

Responsible Party: Anna Kirstine Bojsen-Moeller, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01468116     History of Changes
Other Study ID Numbers: MITBypass
Study First Received: November 7, 2011
Last Updated: November 7, 2011
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Hvidovre University Hospital:
Type 2 diabetes
Gastric bypass surgery
Obesity
Mitochondrial function

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014