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Investigation of Exercise Training-Induced Myokines and Adipolkines in Humans

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ClinicalTrials.gov Identifier: NCT03037216
Recruitment Status : Active, not recruiting
First Posted : January 31, 2017
Last Update Posted : March 1, 2019
Sponsor:
Collaborator:
Daiichi Sankyo, Inc.
Information provided by (Responsible Party):
Joslin Diabetes Center

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single 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 : December 15, 2016
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Changes in circulating proteins in the blood. [ Time Frame: Baseline vs. Post 10 Week Training. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037216


Locations
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United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Joslin Diabetes Center
Daiichi Sankyo, Inc.
Investigators
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Principal Investigator: Laurie J Goodyear, PhD Joslin Diabetes Center

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Responsible Party: Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT03037216     History of Changes
Other Study ID Numbers: 2016-34
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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