Investigation of Exercise Training-Induced Myokines and Adipolkines in Humans

• Sponsor: Joslin Diabetes Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03037216
• Collaborator: Daiichi Sankyo, Inc. (Industry)
• Enrollment: 10
• Location: 1
• Arm: 1
• Actual Duration (Months): 37.6
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Exercise Intervention	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Single Group AssignmentSingle Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Investigation of Exercise Training-Induced Myokines and Adipolkines in Humans
• Actual Study Start Date: Dec 15, 2016
• Actual Primary Completion Date: Dec 1, 2019
• Actual Study Completion Date: Feb 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Changes in circulating proteins in the blood. [Baseline vs. Post 10 Week Training.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Joslin Diabetes Center	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

• Joslin Diabetes Center
• Daiichi Sankyo, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Joslin Diabetes Center
• ClinicalTrials.gov Identifier: NCT03037216
• Other Study ID Numbers: 2016-34
• First Posted: Jan 31, 2017
• Last Update Posted: Aug 20, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Joslin Diabetes Center: Exercise

Study Results

No Results Posted as of Aug 20, 2020