Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Prof Flemming Dela
ORCID ID
http://orcid.org/0000-0001-9970-9535
Contact details
Blegdamsvej 3
Panum bldn.12
4
12
Copenhagen
2200
Denmark
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effect of gastric bypass surgery on mitochondrial function and insulin secretion and action in patients with type 2 diabetes
Acronym
GASMITO
Study hypothesis
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
Ethics Committee of Copenhagen, Denmark (Protocol: H-C-2009-050)
Study design
Observational study
Primary study design
Observational
Secondary study design
Longitudinal study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Drug names
Primary outcome measures
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 trial start date
01/12/2009
Overall trial end date
31/12/2016
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
42
Participant exclusion criteria
1. Endocrine diseases
2. Dysregulated hypertension
3. Hypertension requiring polypharmacy
Recruitment start date
01/12/2009
Recruitment end date
01/07/2014
Locations
Countries of recruitment
Denmark
Trial participating centre
Xlab, Center for Healthy Aging
Department of Biomedical Sciences
University of Copenhagen
Blegdamsvej 3
Panum bldn.12, 4, 12
Copenhagen
2200
Denmark
Funders
Funder type
Research organisation
Funder name
Innovation Fund Denmark
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Nordea Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration.
Intention to publish date
31/12/2017
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary