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

GENETIC SUSCEPTIBILITY FACTOR AS A PREDICTOR OF TYPE 2 DIABETES REMISSION AND WEIGHT LOSS AFTER BARIATRIC SURGERY: HOW TO IDENTIFY THE PATIENTS IN WHICH BARIATRIC SURGERY WILL FAIL?

Sponsors

Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Source Hospital Universitari Vall d'Hebron Research Institute
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.

Overall Status Completed
Start Date July 2013
Completion Date March 2015
Primary Completion Date October 2013
Study Type Observational
Primary Outcome
Measure Time Frame
Predictive value of the genetic test in identifying individuals who will have a good response to bariatric surgery, in terms of weight loss. 6 month
Predictive value of the genetic test in identifying individuals who will have a good response to bariatric surgery, in terms of type 2 diabetes remission after the surgery. 6 month
Enrollment 100
Condition
Intervention

Intervention Type: Genetic

Intervention Name: Genetic test

Description: 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 .

Eligibility

Sampling Method: Probability Sample

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.

Gender: Female

Minimum Age: 18 Years

Maximum Age: 60 Years

Healthy Volunteers: No

Location
Facility: Hospital Universitario Vall d´Hebron
Location Countries

Spain

Verification Date

March 2015

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Label: T2D 40%EWL

Description: 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.

Label: nonT2D40%EWL

Description: 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.

Label: T2D75%EWL

Description: 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.

Label: nonT2D75%EWL

Description: 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.

Acronym OBEGEN
Study Design Info

Observational Model: Case-Control

Time Perspective: Retrospective

Source: ClinicalTrials.gov