Condition category
Nutritional, Metabolic, Endocrine
Date applied
16/01/2015
Date assigned
17/02/2015
Last edited
02/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Sponsor information

Organisation

University of Copenhagen

Sponsor details

Blegdamsvej 3
Copenhagen
2200 N
Denmark
+45 35322626
ku@ku.dk

Sponsor type

University/education

Website

www.ku.dk

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

Publication citations

Additional files

Editorial Notes

02/03/2016: Internal review.