The Effect of Roux-en-Y Gastric Bypass on Mitochondrial Function in Type 2 Diabetes
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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 |
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 |
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| Contact: Kirstine Nyvold Bojsen-Møller, MD | +4538626371 | kirstine.bojsen-moeller@hvh.regionh.dk |
| Contact: Sten Madsbad, professor, MD | +4538622291 | sten.madsbad@hvh.regionh.dk |
| 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 | |
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 June 17, 2013