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
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: 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 July 22, 2014