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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04195061
Other study ID # 2017P001495
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 12, 2019
Est. completion date November 17, 2021

Study information

Verified date January 2024
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date November 17, 2021
Est. primary completion date November 17, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Intervention

Procedure:
Cardiopulmonary exercise test (CPET)
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.

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percent Change in Serum Myostatin Levels From Pre- to 3 Hours Post-exercise Percent change in serum myostatin levels from pre- to 3 hours post-cardiopulmonary exercise test Pre- to 3 hours post-exercise
Secondary Percent Change in Serum Myostatin Levels From Pre- to 2 Hours Post-exercise Percent change in serum myostatin levels from pre- to 2 hours post-cardiopulmonary exercise test Pre- to 2 hours post-exercise
Secondary Percent Change in Serum Myostatin Levels From Immediately Post to 2 Hours Post-exercise Percent change in serum myostatin levels from immediately post to 2 hours post-cardiopulmonary exercise test Immediately post to 2 hours post-exercise
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