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Completed

NCT Number: NCT04195061

Relative Sarcopenia and Cardiometabolic Risk in Young Adults With Obesity

The goal of this research study is to learn more about the hormones that muscles make during exercise, and if those hormones are associated with type 2 diabetes risk in adults who are overweight or obese. Participants will undergo exercise testing on an upright bicycle, with blood samples taken for muscle hormones before and after exercise. The hypothesis is that adults with overweight/obesity and insulin resistance will have an impaired muscle hormone profile in response to exercise compared to adults with overweight/obesity who are not insulin resistant.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Previously enrolled in protocol 2004P000013 or protocol 2012P002276, which had overweight or obesity as inclusion criteria
  • Ability to walk up 3 flights of stairs and 3 city blocks (to ensure ability to complete exercise testing)

Exclusion criteria

  • Unstable heart or lung disease
  • Exercise >150 minutes/week
  • Participation in college sports

Treatment and study plan

cardiopulmonary exercise test (CPET)

Procedure

CPET studies will be performed in the Cardiovascular Performance Program exercise lab at MGH. Subjects will undergo CPET on an upright cycle ergometer with continual measurement of metabolic gas exchange via a commercially available metabolic cart as well as heart rate and blood pressure. Exercise will proceed according to a maximal effort clinical protocol. Subjects will then undergo a standardized 30-min work load on the upright cycle ergometer based on the results of the maximal effort clinical protocol.

Primary outcomes

  1. Percent Change in Serum Myostatin Levels From Pre- to 3 Hours Post-exercise

    Time frame: Pre- to 3 hours post-exercise

    Percent change in serum myostatin levels from pre- to 3 hours post-cardiopulmonary exercise test

Secondary outcomes

  1. Percent Change in Serum Myostatin Levels From Pre- to 2 Hours Post-exercise

    Time frame: Pre- to 2 hours post-exercise

    Percent change in serum myostatin levels from pre- to 2 hours post-cardiopulmonary exercise test

  2. Percent Change in Serum Myostatin Levels From Immediately Post to 2 Hours Post-exercise

    Time frame: Immediately post to 2 hours post-exercise

    Percent change in serum myostatin levels from immediately post to 2 hours post-cardiopulmonary exercise test

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 11, 2019
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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