NCT02441361

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 31, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 12, 2015

Status Verified

May 1, 2015

Enrollment Period

2.8 years

First QC Date

March 31, 2015

Last Update Submit

May 7, 2015

Conditions

Obesity

Outcome Measures

Primary Outcomes (3)

  • insulin sensitivity as assessed by surrogates of insulin sensitivity

    6 months

  • body composition as assessed by densitometry (DEXA)

    bone mass, lean mass and fat mass

    6 months

  • profile of cytokines

    6 months

Secondary Outcomes (6)

  • physical activity level as assessed by accelerometry

    6 months

  • quality of life as assessed by questionnaires (composite)

    6 months

  • muscle function as assessed by a battery of tests

    6 months

  • risk of cardiovascular events as assessed by questionnaires (composite)

    6 months

  • aerobic conditioning as assessed by a cardiopulmonary test.

    6 months

  • +1 more secondary outcomes

Study Arms (2)

control

NO INTERVENTION

Subjects will undergo bariatric surgery and no exercise training will be prescribed.

exercise training

EXPERIMENTAL

Subjects will undergo bariatric surgery and exercise training will be prescribed.

Other: Exercise training

Interventions

Exercise trainingOTHER

Exercise training will comprise aerobic and strength exercises

exercise training

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo

São Paulo, São Paulo, 05508-030, Brazil

RECRUITING

Related Publications (4)

  • Merege-Filho CAA, Gil SS, Kirwan JP, Murai IH, Dantas WS, Nucci MP, Pastorello B, de Lima AP, Bazan PR, Pereira RMR, de Sa-Pinto AL, Lima FR, Brucki SMD, de Cleva R, Santo MA, Leite CDC, Otaduy MCG, Roschel H, Gualano B. Exercise modifies hypothalamic connectivity and brain functional networks in women after bariatric surgery: a randomized clinical trial. Int J Obes (Lond). 2023 Mar;47(3):165-174. doi: 10.1038/s41366-022-01251-8. Epub 2022 Dec 30.

    PMID: 36585494DERIVED

  • 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.

    PMID: 34666419DERIVED

  • 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.

    PMID: 32409493DERIVED

  • 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.

    PMID: 31322672DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 31, 2015

First Posted

May 12, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

May 12, 2015

Record last verified: 2015-05

Locations

BR(1)