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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
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Overweight and Obesity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
December 9, 2019
Last Updated
April 4, 2022
Sponsor
Massachusetts General Hospital
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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

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Relative Sarcopenia and Cardiometabolic Risk in Young Adults With Obesity

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