Effect of gastric bypass surgery on body weight
| ISRCTN | ISRCTN86578521 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86578521 |
| Secondary identifying numbers | N/A |
- Submission date
- 16/01/2015
- Registration date
- 17/02/2015
- Last edited
- 15/12/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Overweight and obesity are increasing and the use of surgery for the treatment of obesity is also rapidly increasing worldwide. This study aims to look at the effects of both diet-induced and surgically-induced weight loss.
Who can participate?
Adults diagnosed with obesity (BMI over 40 kg/m2 or BMI over 35kg/m2 plus obesity-related problems such as diabetes) and scheduled for surgery.
What does the study involve?
Patients will undergo Roux-en-Y gastric bypass. A number of tests and measurements will be done before and after surgery.
What are the possible benefits and risks of participating?
The benefits are a reduction in body weight (mostly fat tissue); resolution of type 2 diabetes, a disorder in which an organ called the pancreas does not produce enough insulin or the individual’s cells do not react to the insulin, leading to high blood sugar levels; and improvements in insulin sensitivity. Risks were not provided at the time of registration.
Where is the study run from?
Xlab, Center for Healthy Aging (Denmark)
When is the study starting and how long is it expected to run for?
December 2009 to December 2016
Who is funding the study?
Innovation Fund Denmark
Who is the main contact?
Professor Flemming Dela
Contact information
Scientific
Blegdamsvej 3
Panum bldn.12, 4, 12
Copenhagen
2200
Denmark
 ORCID ID |
0000-0001-9970-9535 |
|---|
Study information
| Study design | Observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Effect of gastric bypass surgery on mitochondrial function and insulin secretion and action in patients with type 2 diabetes |
| Study acronym | GASMITO |
| Study objectives | Weight loss induced with diet and surgery will: 1. Improve insulin action and secretion 2. Increase mass-specific adipose tissue mitochondrial respiration 3. Not change skeletal muscle mass-specific mitochondrial respiration 4. Not reduce maximal fat oxidation |
| Ethics approval(s) | Ethics Committee of Copenhagen, Denmark (Protocol: H-C-2009-050) |
| Health condition(s) or problem(s) studied | Insulin resistance |
| Intervention | Obese patients with and without type 2 diabetes will be assessed twice before and twice after Roux-en-Y gastric bypass with: 1. Intravenous glucose tolerance test 2. Oral glucose tolerance test 3. Euglycaemic clamp 4. Indirect calorimetry 5. Maximal oxygen consumption 6. Maximal fat oxidation rate 7. Dual energy X-ray absorptiometry scan 8. Biopsy samples of skeletal muscle and subcutaneous, hepatic and visceral fat |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Insulin action 2. Insulin secretion 3. Maximal oxygen consumption 4. Mitochondrial respiration 5. Fat oxidation during exercise |
| Secondary outcome measures | 1. Body composition 2. Hepatic glucose production and mitochondrial function 3. Lipolysis 4. Incretin hormones |
| Overall study start date | 01/12/2009 |
| Completion date | 31/12/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 42 |
| Key inclusion criteria | Before 31/01/2011 1. Age 18–60 years old 2. Body mass index (BMI) >40 kg/m2 or >35kg/m2 with obesity-related comorbidities (e.g., type 2 diabetes) After 31/01/2011 1. Age 25–60 years old 2. BMI >50 kg/m2 or BMI >35kg/m2 with obesity-related comorbidities |
| Key exclusion criteria | 1. Endocrine diseases 2. Dysregulated hypertension 3. Hypertension requiring polypharmacy |
| Date of first enrolment | 01/12/2009 |
| Date of final enrolment | 01/07/2014 |
Locations
Countries of recruitment
- Denmark
Study participating centre
University of Copenhagen
Blegdamsvej 3
Panum bldn.12, 4, 12
Copenhagen
2200
Denmark
Sponsor information
University/education
Blegdamsvej 3
Copenhagen
2200 N
Denmark
| Phone | +45 35322626 |
|---|---|
| ku@ku.dk | |
| Website | www.ku.dk |
"ROR" |
https://ror.org/035b05819 |
Funders
Funder type
Research organisation
No information available
No information available
Results and Publications
| Intention to publish date | 31/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2015 | Yes | No | |
| Results article | results | 15/07/2015 | Yes | No | |
| Results article | results | 01/10/2015 | Yes | No | |
| Results article | results | 01/06/2016 | Yes | No | |
| Results article | results | 01/07/2016 | Yes | No | |
| Results article | results | 01/08/2016 | Yes | No | |
| Results article | results | 01/12/2016 | Yes | No | |
| Results article | results | 01/11/2017 | Yes | No |
Editorial Notes
15/12/2017: Publication references added.
02/03/2016: Internal review.
