NCT03037216

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 26, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 31, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

August 20, 2020

Status Verified

August 1, 2020

Enrollment Period

3 years

First QC Date

January 26, 2017

Last Update Submit

August 19, 2020

Conditions

Healthy

Keywords

Exercise

Outcome Measures

Primary Outcomes (1)

  • Changes in circulating proteins in the blood.

    Baseline vs. Post 10 Week Training.

Study Arms (1)

Experimental Exercise-Training Intervention

EXPERIMENTAL

Subjects will undergo a 10-week aerobic exercise protocol.

Other: Exercise Intervention

Interventions

Exercise InterventionOTHER

10 Week aerobic exercise training

Experimental Exercise-Training Intervention

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Laurie J Goodyear, PhD

    Joslin Diabetes Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Single Group Assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2017

First Posted

January 31, 2017

Study Start

December 15, 2016

Primary Completion

December 1, 2019

Study Completion

February 1, 2020

Last Updated

August 20, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)