GENETIC SUSCEPTIBILITY FACTOR AS A PREDICTOR OF TYPE 2 DIABETES REMISSION AND WEIGHT LOSS AFTER BARIATRIC SURGERY

NCT ID: NCT02405949

Last Updated: 2015-04-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2015-03-31

Brief Summary

Obesity is directly related to an increased risk of diabetes mellitus, hypertension, dyslipidemia, cardiovascular disease, and overall mortality. Weight loss is effective in decreasing these risks and to reduce disease severity. Bariatric surgery is an effective therapy for sustained weight loss and type 2 diabetes (T2D) remission in most of the morbidly obese patients. But there is also a significant number of individuals with an inappropriate response to bariatric surgery. Two recent retrospective studies assessed the role of genetic load as a predictor of this response, but the results are still unelucidated. The aim of this study is to assess whether a selection of genetic variants may allow us to identify individuals who will have a satisfactory response after bariatric surgery in terms of weight loss and T2D remission.

Detailed Description

A retrospective case-control study of 100 women who underwent bariatric surgery (Roux-en-Y laparoscopic gastric bypass): 50 pacients who were diabetic before surgery: 15 cases with less than 40% of the excess weight loss (EWL) and 35 cases with more than 75% EWL, matched with 50 non diabetic controles: 15 patients with less than 40%EWL and 35 with more than 75%EWL after one year. All individuals were analyzed with a genetic score from Nutri inCode. The predictive ability was analyzed by discrimination (area under the ROC curve), sensitivity and specificity and a score was calculated.

Conditions

Case-control Study

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

T2D 40%EWL

15 pacients who had type 2 diabetes before bariatric surgery and presented with less than 40% of the excess weight loss after 12 month from surgery.

Genetic test

Intervention Type: GENETIC

Analysis of the main genetic variants associated with obesity are evaluated, mainly those related to the regulation of appetite, energy expenditure, adipogenesis, diabetes, inflammation of adipose tissue and others .

nonT2D40%EWL

15 pacients without type 2 diabetes before bariatric surgery and presented with less than 40% of the excess weight loss after 12 month from surgery.

Genetic test

Intervention Type: GENETIC

Analysis of the main genetic variants associated with obesity are evaluated, mainly those related to the regulation of appetite, energy expenditure, adipogenesis, diabetes, inflammation of adipose tissue and others .

T2D75%EWL

35 pacients who had type 2 diabetes befor bariatric surgery and presented with more than 75% of the excess weight loss after 12 month from surgery.

Genetic test

Intervention Type: GENETIC

Analysis of the main genetic variants associated with obesity are evaluated, mainly those related to the regulation of appetite, energy expenditure, adipogenesis, diabetes, inflammation of adipose tissue and others .

nonT2D75%EWL

35 pacients without type 2 diabetes befor bariatric surgery and who presented with more than 75% of the excess weight loss after 12 month from surgery.

Genetic test

Intervention Type: GENETIC

Analysis of the main genetic variants associated with obesity are evaluated, mainly those related to the regulation of appetite, energy expenditure, adipogenesis, diabetes, inflammation of adipose tissue and others .

Interventions

Genetic test

Analysis of the main genetic variants associated with obesity are evaluated, mainly those related to the regulation of appetite, energy expenditure, adipogenesis, diabetes, inflammation of adipose tissue and others .

Intervention Type: GENETIC

Eligibility Criteria

Inclusion Criteria

• women who underwent a gastric bypass with a minimum of 1 year follow-up,
• aged between 18 and 60 years,
• stable weight in the previous 6 months,
• have signed the informed consent.

Exclusion Criteria

• male,
• with mobility problems that constrain a marked inactivity,
• with pathology that limits the practice of within normal limits (chronic obstructive pulmonary cardiac cerebral vascular-disease, illness, accident sequel, etc ),
• undergoing different surgical techniques to gastric bypass,
• with severe psychiatric disorders or eating disorder.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Universitario Vall d´Hebron

Barcelona, , Spain

Countries

Spain

Other Identifiers

PR(AG) 86/2013

Identifier Type: -

Identifier Source: org_study_id