Relative Sarcopenia and Cardiometabolic Risk in Young Adults With Obesity

Insulin Resistance Clinical Trial

Official title:

Relative Sarcopenia and Cardiometabolic Risk in Young Adults With Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04195061
• Other study ID #: 2017P001495
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity
• Overweight
• Overweight and Obesity
• Sarcopenia

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