Relative Sarcopenia and Cardiometabolic Risk in Young Adults With Obesity

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04195061
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arm: 1
• Actual Duration (Months): 23.2
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity; Insulin Resistance	Procedure: Cardiopulmonary exercise test (CPET)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Relative Sarcopenia and Cardiometabolic Risk in Young Adults With Obesity
• Actual Study Start Date: Dec 12, 2019
• Actual Primary Completion Date: Nov 17, 2021
• Actual Study Completion Date: Nov 17, 2021

Arms and Interventions

Arm

Intervention/Treatment

Other: Cardiopulmonary exercise testing

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.

Outcome Measures

Primary Outcome Measures

1. Myostatin [Pre- to 3-hours post-exercise]

   Change in serum myostatin levels

Secondary Outcome Measures

1. Irisin [Pre- to 3-hours post-exercise]

   Change in serum irisin levels

2. IL-6 [Pre- to 3-hours post-exercise]

   Change in serum IL-6 levels

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital

Investigators

• Principal Investigator: Melanie S Haines, MD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Melanie Schorr Haines, M.D, Principal Investigator, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT04195061
• Other Study ID Numbers: 2017P001495
• First Posted: Dec 11, 2019
• Last Update Posted: Apr 6, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sarcopenia; Obesity; Insulin Resistance; Overweight

Study Results

No Results Posted as of Apr 6, 2022