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OpenTrials
Completed

NCT Number: NCT02405949

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

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.

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Key information

Conditions

Case-control Study

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Hospital Universitario Vall d´Hebron

Barcelona, 08035, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Genetic Test

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 .

Primary outcomes

  1. Predictive value of the genetic test in identifying individuals who will have a good response to bariatric surgery, in terms of weight loss.

    Time frame: 6 month

    Predictive value of the genetic test in identifying individuals who will have a good response to bariatric surgery, in terms of weight loss.

  2. 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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

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?

Acronym: OBEGEN

Important dates

Study start
2013
Primary completion
2013
Study completion
2015
First posted
Apr 1, 2015
Registry last updated
Apr 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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