Clinical trial NCT02441361: Effects of Exercise Training in Bariatric Patients
Official title: Effects of Exercise in Bariatric Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2015-05-12
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Bariatric surgery may attenuate insulin resistance and low-grade inflammation in obese subjects. This trial aims to test whether exercise training can add to the benefits of bariatric surgery on insulin sensitivity and inflammation. In addition, this study aims to investigate whether exercise training can counteract bone loss induced by bariatric surgery.


Eligibility criteria: Inclusion Criteria:

* body mass index ≥ 35 kg/m2
* not engaged in physical activity programs
* without any physical limitation that could preclude exercise participation

Exclusion Criteria:

* body mass index \< 35 kg/m2
* regular participation in physical activities programs
* cancer or any other disease that could limit participation in exercise

Primary outcomes:
measure: insulin sensitivity as assessed by surrogates of insulin sensitivity
timeFrame: 6 months
measure: body composition as assessed by densitometry (DEXA)
timeFrame: 6 months
measure: profile of cytokines
timeFrame: 6 months
Secondary outcomes:
measure: physical activity level as assessed by accelerometry
timeFrame: 6 months
measure: quality of life as assessed by questionnaires (composite)
timeFrame: 6 months
measure: muscle function as assessed by a battery of tests
timeFrame: 6 months
measure: risk of cardiovascular events as assessed by questionnaires (composite)
timeFrame: 6 months
measure: aerobic conditioning as assessed by a cardiopulmonary test.
timeFrame: 6 months
measure: depression and anxiety as assessed by questionnaires (composite)
timeFrame: 6 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo
Study officials:
References:
citation: Gil S, Kirwan JP, Murai IH, Dantas WS, Merege-Filho CAA, Ghosh S, Shinjo SK, Pereira RMR, Teodoro WR, Felau SM, Benatti FB, de Sa-Pinto AL, Lima F, de Cleva R, Santo MA, Gualano B, Roschel H. A randomized clinical trial on the effects of exercise on muscle remodelling following bariatric surgery. J Cachexia Sarcopenia Muscle. 2021 Dec;12(6):1440-1455. doi: 10.1002/jcsm.12815. Epub 2021 Oct 19.
citation: Dantas WS, Roschel H, Murai IH, Gil S, Davuluri G, Axelrod CL, Ghosh S, Newman SS, Zhang H, Shinjo SK, das Neves W, Merege-Filho C, Teodoro WR, Capelozzi VL, Pereira RM, Benatti FB, de Sa-Pinto AL, de Cleva R, Santo MA, Kirwan JP, Gualano B. Exercise-Induced Increases in Insulin Sensitivity After Bariatric Surgery Are Mediated By Muscle Extracellular Matrix Remodeling. Diabetes. 2020 Aug;69(8):1675-1691. doi: 10.2337/db19-1180. Epub 2020 May 14.
citation: Murai IH, Roschel H, Dantas WS, Gil S, Merege-Filho C, de Cleva R, de Sa-Pinto AL, Lima F, Santo MA, Benatti FB, Kirwan JP, Pereira RM, Gualano B. Exercise Mitigates Bone Loss in Women With Severe Obesity After Roux-en-Y Gastric Bypass: A Randomized Controlled Trial. J Clin Endocrinol Metab. 2019 Oct 1;104(10):4639-4650. doi: 10.1210/jc.2019-00074.