Investigation of Exercise Training-Induced Myokines and Adipolkines in Humans

August 19, 2020 updated by: Joslin Diabetes Center
The purpose of this study is to find out whether exercise training leads to changes in the blood that are produced by exercised muscles and if these changes produce new hormones that affect the body's regulation of sugar and body weight.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Joslin Diabetes Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Age between 18-35. Body mass index (BMI) must be ≥18.5 and ≤27 kg/m2. HbA1c values ≤5.7%

Exclusion Criteria:

  • Age <18 and >50
  • HbA1c ≥ 5.7%; heart or lung disease
  • acute systemic infection accompanied by fever, body aches, or swollen lymph glands
  • BMI > 27 kg/m2
  • current dieting or weight loss efforts
  • current pregnancy or breastfeeding
  • known history of HIV/AIDS; cancer
  • biochemical evidence of renal or hepatic dysfunction; renal or liver disease demyelinating diseases such as multiple sclerosis or amyotrophic lateral sclerosis
  • recent blood donation
  • clinical history of stroke
  • hypertension (systolic > 140 mmHg or diastolic > 90 mmHg)
  • type 1 or 2 diabetes; inability to exercise at 50% of predicted heart rate (HR) reserve at baseline
  • Participants taking beta-blockers Participants who screen positive for The American Heart Association's contraindications to exercise testing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Exercise-Training Intervention
Subjects will undergo a 10-week aerobic exercise protocol.
Other: Exercise Intervention
10 Week aerobic exercise training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in circulating proteins in the blood.
Time Frame: Baseline vs. Post 10 Week Training.
Baseline vs. Post 10 Week Training.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joslin Diabetes Center

Collaborators

Daiichi Sankyo, Inc.

Investigators

  • Principal Investigator: Laurie J Goodyear, PhD, Joslin Diabetes Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2016

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

February 1, 2020

Study Registration Dates

First Submitted

January 26, 2017

First Submitted That Met QC Criteria

January 27, 2017

First Posted (Estimate)

January 31, 2017

Study Record Updates

Last Update Posted (Actual)

August 20, 2020

Last Update Submitted That Met QC Criteria

August 19, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2016-34

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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