Muscle Assessment in Women Who Have Undergone Roux-en-Y Gastric Bypass Surgery (FUBA)

March 4, 2019 updated by: Pamela Rojas, University of Chile

Assessment of the Muscle Function Test in Women Who Have Undergone Roux-en-Y Gastric Bypass Surgery

The purpose of this study is to assess muscle function in women at least two years after being submitted to Roux-en-Y Gastric Bypass Surgery and compare with a control group

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Obesity is a public health problem globally. According to the World Health Organization (WHO) estimated are 600 million obese worldwide and according to National Health Survey 2010 in Chile 67% of the population suffers from some degree of overweight having approximately 300,000 morbidly obese.

The first-line treatment for obesity is diet, exercise and cognitive behavioral therapy, however, these interventions are not effective enough to control long-term obesity, and so bariatric surgery is currently the treatment of choice to control morbid obesity.

Overall, after bariatric surgery, most patients lose on average 60% of excess weight and improve their comorbidities during the first postoperative year, however, the long term effects of this weight reduction are not known in detail regarding body composition and muscle function.

The aim of this study is to assess muscle function measured by hand grip strength test in women at least 2 years after bariatric surgery (Roux-en-Y Gastric Bypass) and to compare with control group.

Study Type

Observational

Enrollment (Actual)

26

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

  • Chile
    • Metropolitana
      • Santiago, Metropolitana, Chile
        • University of Chile

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Two groups of study subjects: bariatric surgery group (case group) and nonoperated group (control group)

The case group will be composed of women that were operated two or more years ago of Roux-en-Y Gastric Bypass Surgery, with a 50% or less weight regain.

The control group will be composed of subjects with no history of bariatric surgery and match with the surgical group by gender, age, body mass index (BMI) and physical activity

Control group will be selected form people who work or study in Faculty of Medicine, University of Chile and case group will be selected from former patients evaluated at Nutrition Department of the University of Chile.

Description

Inclusion Criteria:

Case group: women, 18-70 y, submitted to a Roux-en-Y Gastric Bypass Surgery at least two years ago

Exclusion Criteria:

  • osteoarthritis of hands and knees, any osteoarticular, rheumatologic or neurological disease hindering the performance of the tests of muscle function; type 2 diabetes mellitus; acute infectious diseases; use of muscle relaxants; physical and intellectual disabilities and uncontrolled hypothyroidism.

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: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Bariatric surgery
Women who have been submitted to a Roux-en-Y Gastric Bypass Surgery for at least 2 years
Other: Assess muscle function
Assess muscle function with hand grip test and sit and stand test
Unoperated
Women with similar characteristics to control group (age, body mass index, physical activity level), but they have not been submitted to bariatric surgery
Other: Assess muscle function
Assess muscle function with hand grip test and sit and stand test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Handgrip strength
Time Frame: One time (initial assesment)
Assess handgrip test with a "Jamar®" hydraulic hand dynamometer
One time (initial assesment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sit and stand
Time Frame: One time (initial assesment)
Number of repetitions of sit ups within 30 seconds
One time (initial assesment)
Physical Activity Level
Time Frame: One time (initial assesment)
Assessment with International Physical Activity Questionnaires (IPAQ)
One time (initial assesment)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutritional status of some vitamins and minerals
Time Frame: One time (initial assesment)
Some vitamins and minerals related to muscle function will be measured in plasma or serum.
One time (initial assesment)
Body composition
Time Frame: One time (initial assesment)
Fat free mass is determined with a whole body Dual-energy X-ray Absorptiometry (DXA) scan
One time (initial assesment)

Collaborators and Investigators

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

Sponsor

University of Chile

Collaborators

Asociación Chilena de Nutrición Clínica, Obesidad y Metabolismo

Investigators

  • Principal Investigator: Andres F Sanchez, MD, MSc, University of Chile
  • Study Director: Pamela A Rojas, MD, MSc, University of Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

June 1, 2016

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

June 21, 2016

First Submitted That Met QC Criteria

June 21, 2016

First Posted (Estimate)

June 23, 2016

Study Record Updates

Last Update Posted (Actual)

March 6, 2019

Last Update Submitted That Met QC Criteria

March 4, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ACHINUMET1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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