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

March 31, 2015 updated by: Hospital Universitari Vall d'Hebron Research Institute

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?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d´Hebron

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

The trial aimed to recruit a total of 100 female subjects who underwent a gastric bypass in our cente with more than one year of monitoring. These 100 subjects were distributed into 4 subgroups according to the percentage of excess weight loss (%EWL) and the presence or absence of type 2 diabetes before surgery:

15 women with %EWL <40% without diabetes 15 women with <40%EWL with type 2 diabetes 35 women with a %EWL> 75% without comorbidities 35 women with a %EWL> 75% with type 2 diabetes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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: 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 .
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: 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 .
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: 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 .
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: 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
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.
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.
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.
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.
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

March 28, 2015

First Submitted That Met QC Criteria

March 31, 2015

First Posted (Estimate)

April 1, 2015

Study Record Updates

Last Update Posted (Estimate)

April 1, 2015

Last Update Submitted That Met QC Criteria

March 31, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR(AG) 86/2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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