Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 2 for:    26743210 [PUBMED-IDS]

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02811393
Recruitment Status : Completed
First Posted : June 23, 2016
Last Update Posted : March 6, 2019
Sponsor:
Collaborator:
Asociación Chilena de Nutrición Clínica, Obesidad y Metabolismo
Information provided by (Responsible Party):
Pamela Rojas, University of Chile

Brief Summary:
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

Condition or disease Intervention/treatment
Muscle Function, Handgrip Strength Test Other: Assess muscle function

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.


Layout table for study information
Study Type : Observational
Actual Enrollment : 26 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Assessment of the Muscle Function Test in Women Who Have Undergone Roux-en-Y Gastric Bypass Surgery
Study Start Date : June 2016
Actual Primary Completion Date : December 2018
Actual Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Handgrip strength [ Time Frame: One time (initial assesment) ]
    Assess handgrip test with a "Jamar®" hydraulic hand dynamometer


Secondary Outcome Measures :
  1. Sit and stand [ Time Frame: One time (initial assesment) ]
    Number of repetitions of sit ups within 30 seconds

  2. Physical Activity Level [ Time Frame: One time (initial assesment) ]
    Assessment with International Physical Activity Questionnaires (IPAQ)


Other Outcome Measures:
  1. 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.

  2. Body composition [ Time Frame: One time (initial assesment) ]
    Fat free mass is determined with a whole body Dual-energy X-ray Absorptiometry (DXA) scan


Biospecimen Retention:   Samples Without DNA
serum, urine.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811393


Locations
Layout table for location information
Chile
University of Chile
Santiago, Metropolitana, Chile
Sponsors and Collaborators
University of Chile
Asociación Chilena de Nutrición Clínica, Obesidad y Metabolismo
Investigators
Layout table for investigator information
Principal Investigator: Andres F Sanchez, MD, MSc University of Chile
Study Director: Pamela A Rojas, MD, MSc University of Chile
  Study Documents (Full-Text)

Documents provided by Pamela Rojas, University of Chile:
Statistical Analysis Plan  [PDF] March 4, 2019


Additional Information:
Publications of Results:

Layout table for additonal information
Responsible Party: Pamela Rojas, Assistant professor, University of Chile
ClinicalTrials.gov Identifier: NCT02811393     History of Changes
Other Study ID Numbers: ACHINUMET1
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Pamela Rojas, University of Chile:
Bariatric surgery, sarcopenia