NCT01468116

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

November 9, 2011

Status Verified

November 1, 2011

Enrollment Period

2.3 years

First QC Date

November 7, 2011

Last Update Submit

November 7, 2011

Conditions

Type 2 DiabetesObesity

Keywords

Type 2 diabetesGastric bypass surgeryObesityMitochondrial function

Study Arms (3)

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects are recruited from the outpatient clinic of endocrinology and the gastrosurgical clinic at Hvidovre University Hospital

You may qualify if:

  • Patients eligible for gastric bypass surgery or cholecystectomy
  • Verified type 2 diabetes or normal glucose tolerance by OGTT

You may not qualify if:

  • Patients unable to fit the dimensions of the MRI-scanner

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre University Hospital

Copenhagen, Hvidovre, DK-2650, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, plasma

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Obesity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Kirstine Nyvold Bojsen-Møller, MD

CONTACT

+4538626371kirstine.bojsen-moeller@hvh.regionh.dk

Sten Madsbad, professor, MD

CONTACT

+4538622291sten.madsbad@hvh.regionh.dk

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 7, 2011

First Posted

November 9, 2011

Study Start

March 1, 2011

Primary Completion

June 1, 2013

Study Completion

December 1, 2013

Last Updated

November 9, 2011

Record last verified: 2011-11

Locations

DK(1)