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

NCT ID: NCT01468116

Last Updated: 2011-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Type 2 Diabetes Obesity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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RYGB patients with type 2 diabetes

Morbidly obese patients with type 2 diabetes undergoing gastric bypass surgery

No interventions assigned to this group

RYGB patients without type 2 diabetes

Morbidly obese patients with normal glucose tolerance undergoing gastric bypass surgery

No interventions assigned to this group

Cholecystectomy patients without type 2 diabetes

Patients with normal glucose tolerance undergoing laparoscopically cholecystectomy

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Copenhagen

OTHER

Sponsor Role collaborator

Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Anna Kirstine Bojsen-Moeller

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hvidovre University Hospital

Copenhagen, Hvidovre, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Kirstine Nyvold Bojsen-Møller, MD

Role: CONTACT

[email protected]
+4538626371

Sten Madsbad, professor, MD

Role: CONTACT

[email protected]
+4538622291

Facility Contacts

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Kirstine Nyvold Bojsen-Møller, MD

Role: primary

[email protected]
+4538626371

Other Identifiers

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MITBypass

Identifier Type: -

Identifier Source: org_study_id