Relative Sarcopenia and Cardiometabolic Risk in Young Adults With Obesity

NCT04195061 | Completed Results DMC

• 1 other identifier: 2017P001495
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity; Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Percent Change in Serum Myostatin Levels From Pre- to 2 Hours Post-exercise

  Pre- to 2 hours post-exercise

• Percent Change in Serum Myostatin Levels From Immediately Post to 2 Hours Post-exercise

  Immediately post to 2 hours post-exercise

Study Arms (1)

Cardiopulmonary exercise testing

Procedure: Cardiopulmonary exercise test (CPET)

Interventions

Cardiopulmonary exercise test (CPET) PROCEDURE

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.

Cardiopulmonary exercise testing

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with overweight or obesity

You may qualify if:

• Ability to walk up 3 flights of stairs and 3 city blocks (to ensure ability to complete exercise testing)

You may not qualify if:

• Unstable heart or lung disease
• Exercise \>150 minutes/week
• Participation in college sports

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Insulin Resistance

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Results Point of Contact

• Title: Melanie S. Haines, MD
• Organization: Massachusetts General Hospital

mshaines@mgh.harvard.edu

617-726-3870

Study Officials

• Melanie S Haines, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 11, 2019
• Study Start: December 12, 2019
• Primary Completion: November 17, 2021
• Study Completion: November 17, 2021
• Last Updated: January 30, 2024
• Results First Posted: January 30, 2024

Record last verified: 2024-01

Locations

US (1)