Relative Sarcopenia and Cardiometabolic Risk in Young Adults With Obesity

NCT ID: NCT04195061

Last Updated: 2024-01-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-12

Study Completion Date

2021-11-17

Brief Summary

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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.

Detailed Description

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Conditions

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Overweight and Obesity Insulin Resistance

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Cardiopulmonary exercise testing

Cardiopulmonary exercise test (CPET)

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Melanie Schorr Haines, M.D

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Melanie S Haines, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2017P001495

Identifier Type: -

Identifier Source: org_study_id

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