NCT02405949

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 1, 2015

Completed
Last Updated

April 1, 2015

Status Verified

March 1, 2015

Enrollment Period

3 months

First QC Date

March 28, 2015

Last Update Submit

March 31, 2015

Conditions

Case-control Study

Outcome Measures

Primary Outcomes (2)

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

    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.

    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

Study Arms (4)

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

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

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

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

Interventions

Genetic testGENETIC

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 .

T2D 40%EWLT2D75%EWLnonT2D40%EWLnonT2D75%EWL

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Vall d´Hebron

Barcelona, 08035, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample

MeSH Terms

Interventions

Genetic Testing

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic TechniquesGenetic ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDiagnostic ServicesPreventive Health Services

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2015

First Posted

April 1, 2015

Study Start

July 1, 2013

Primary Completion

October 1, 2013

Study Completion

March 1, 2015

Last Updated

April 1, 2015

Record last verified: 2015-03

Locations

ES(1)