Investigation of Exercise Training-Induced Myokines and Adipolkines in Humans

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: Healthy
• Intervention / Treatment: Other: Exercise Intervention

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 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

How is the study designed?

Design Details

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

Number of Arms

1

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.	Baseline vs. Post 10 Week Training.

Collaborators and Investigators

• Sponsor: Joslin Diabetes Center
• Collaborators: Daiichi Sankyo, Inc.
• Investigators: Principal Investigator: Laurie J Goodyear, PhD, Joslin Diabetes Center

Study record dates

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: Exercise
• 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