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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

Tracking Information
First Submitted Date June 21, 2016
First Posted Date June 23, 2016
Last Update Posted Date March 6, 2019
Study Start Date June 2016
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 21, 2016)
Handgrip strength [ Time Frame: One time (initial assesment) ]
Assess handgrip test with a "Jamar®" hydraulic hand dynamometer
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 21, 2016)
  • Sit and stand [ Time Frame: One time (initial assesment) ]
    Number of repetitions of sit ups within 30 seconds
  • Physical Activity Level [ Time Frame: One time (initial assesment) ]
    Assessment with International Physical Activity Questionnaires (IPAQ)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 21, 2016)
  • 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.
  • Body composition [ Time Frame: One time (initial assesment) ]
    Fat free mass is determined with a whole body Dual-energy X-ray Absorptiometry (DXA) scan
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Muscle Assessment in Women Who Have Undergone Roux-en-Y Gastric Bypass Surgery
Official Title Assessment of the Muscle Function Test in Women Who Have Undergone Roux-en-Y Gastric Bypass Surgery
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
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
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
serum, urine.
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.

Condition Muscle Function, Handgrip Strength Test
Intervention Other: Assess muscle function
Assess muscle function with hand grip test and sit and stand test
Study Groups/Cohorts
  • Bariatric surgery
    Women who have been submitted to a Roux-en-Y Gastric Bypass Surgery for at least 2 years
    Intervention: Other: Assess muscle function
  • Unoperated
    Women with similar characteristics to control group (age, body mass index, physical activity level), but they have not been submitted to bariatric surgery
    Intervention: Other: Assess muscle function
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 21, 2016)
26
Original Estimated Enrollment Same as current
Actual Study Completion Date January 2019
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Chile
Removed Location Countries  
 
Administrative Information
NCT Number NCT02811393
Other Study ID Numbers ACHINUMET1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Pamela Rojas, University of Chile
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
PRS Account University of Chile
Verification Date March 2019