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ObesityNCT02441361

Effects of Exercise Training in Bariatric Patients

A study testing Exercise training in people with Obesity, run by University of Sao Paulo at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Exercise training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteBrazil
Study dates
Mar 2015to Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Brazil1 site, 1 recruiting

  • University of Sao Paulo

    São Paulo, São Paulo, 05508-030

    Igor Murai, master, 551130918783, gualano@usp.br

    Bruno Gualano, Professor

    Recruiting

Other trials in Brazil

About this study

Official title: Effects of Exercise in Bariatric Patients: a Randomized Controlled Trial

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.

Conditions
Obesity
Being tested
Exercise training
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02441361
Study groupRoleWhat they receive
controlNo interventionSubjects will undergo bariatric surgery and no exercise training will be prescribed.
exercise trainingExperimentalSubjects will undergo bariatric surgery and exercise training will be prescribed.
Receives: Other: Exercise training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. insulin sensitivity as assessed by surrogates of insulin sensitivity

    Measured: 6 months

  2. body composition as assessed by densitometry (DEXA)

    bone mass, lean mass and fat mass

    Measured: 6 months

  3. profile of cytokines

    Measured: 6 months

Secondary outcomes (6)

  1. physical activity level as assessed by accelerometry

    Measured: 6 months

  2. quality of life as assessed by questionnaires (composite)

    Measured: 6 months

  3. muscle function as assessed by a battery of tests

    timed-stands test, timed-up-ang-go test, maximal strength tests

    Measured: 6 months

  4. risk of cardiovascular events as assessed by questionnaires (composite)

    Measured: 6 months

  5. aerobic conditioning as assessed by a cardiopulmonary test.

    Measured: 6 months

  6. depression and anxiety as assessed by questionnaires (composite)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionDec 2017 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02441361
Sponsor's protocol ID
Exercise & Bariatric
Status last verified
May 2015
First submitted
31 Mar 2015
Last updated
12 May 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 36585494

  • 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.

    PubMed 34666419

  • 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.

    PubMed 32409493

  • 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.

    PubMed 31322672

Questions about this trial

What is this clinical trial studying?

A study testing Exercise training in people with Obesity, run by University of Sao Paulo at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

insulin sensitivity as assessed by surrogates of insulin sensitivity (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02441361, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2015.

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