Relative Sarcopenia and Cardiometabolic Risk in Young Adults With Obesity
Primary Purpose
Overweight and Obesity, Insulin Resistance
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cardiopulmonary exercise test (CPET)
Sponsored by
About this trial
This is an interventional other trial for Overweight and Obesity
Eligibility Criteria
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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Cardiopulmonary exercise testing
Arm Description
Outcomes
Primary Outcome Measures
Myostatin
Change in serum myostatin levels
Secondary Outcome Measures
Irisin
Change in serum irisin levels
IL-6
Change in serum IL-6 levels
Full Information
NCT ID
NCT04195061
First Posted
December 9, 2019
Last Updated
April 4, 2022
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04195061
Brief Title
Relative Sarcopenia and Cardiometabolic Risk in Young Adults With Obesity
Official Title
Relative Sarcopenia and Cardiometabolic Risk in Young Adults With Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
December 12, 2019 (Actual)
Primary Completion Date
November 17, 2021 (Actual)
Study Completion Date
November 17, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Insulin Resistance
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cardiopulmonary exercise testing
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Cardiopulmonary exercise test (CPET)
Intervention Description
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 Outcome Measure Information:
Title
Myostatin
Description
Change in serum myostatin levels
Time Frame
Pre- to 3-hours post-exercise
Secondary Outcome Measure Information:
Title
Irisin
Description
Change in serum irisin levels
Time Frame
Pre- to 3-hours post-exercise
Title
IL-6
Description
Change in serum IL-6 levels
Time Frame
Pre- to 3-hours post-exercise
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melanie S Haines, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Relative Sarcopenia and Cardiometabolic Risk in Young Adults With Obesity
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