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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2011 by Hvidovre University Hospital.
Recruitment status was:  Recruiting
University of Copenhagen
Information provided by (Responsible Party):
Anna Kirstine Bojsen-Moeller, Hvidovre University Hospital Identifier:
First received: November 7, 2011
Last updated: NA
Last verified: November 2011
History: No changes posted
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.

Type 2 Diabetes

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

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)
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.

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

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 identifier: NCT01468116

Contact: Kirstine Nyvold Bojsen-Møller, MD +4538626371
Contact: Sten Madsbad, professor, MD +4538622291

Hvidovre University Hospital Recruiting
Copenhagen, Hvidovre, Denmark, DK-2650
Contact: Kirstine Nyvold Bojsen-Møller, MD    +4538626371   
Principal Investigator: Kirstine Nyvold Bojsen-Møller, MD         
Sponsors and Collaborators
Hvidovre University Hospital
University of Copenhagen
  More Information

Responsible Party: Anna Kirstine Bojsen-Moeller, MD, Hvidovre University Hospital Identifier: NCT01468116     History of Changes
Other Study ID Numbers: MITBypass
Study First Received: November 7, 2011
Last Updated: November 7, 2011

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

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases processed this record on March 28, 2017