ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01468116
Recruitment Status : Unknown
Verified November 2011 by Anna Kirstine Bojsen-Moeller, Hvidovre University Hospital.
Recruitment status was:  Recruiting
First Posted : November 9, 2011
Last Update Posted : November 9, 2011
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Anna Kirstine Bojsen-Moeller, Hvidovre University Hospital

Brief Summary:
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 or disease
Type 2 Diabetes Obesity

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.

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case Control
Time Perspective: Prospective
Study Start Date : March 2011
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
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



Biospecimen Retention:   Samples Without DNA
serum, plasma


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Anna Kirstine Bojsen-Moeller, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01468116     History of Changes
Other Study ID Numbers: MITBypass
First Posted: November 9, 2011    Key Record Dates
Last Update Posted: November 9, 2011
Last Verified: November 2011

Keywords provided by Anna Kirstine Bojsen-Moeller, Hvidovre University Hospital:
Type 2 diabetes
Gastric bypass surgery
Obesity
Mitochondrial function

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases