NCT02565823

Brief Summary

The purpose of this study is to find out whether exercise 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
12

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Oct 2015

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

First Submitted

Initial submission to the registry

September 30, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

April 21, 2016

Status Verified

April 1, 2016

Enrollment Period

5 months

First QC Date

September 30, 2015

Last Update Submit

April 19, 2016

Conditions

Keywords

Exercise

Outcome Measures

Primary Outcomes (1)

  • Changes in myokines/adipokine concentration

    baseline, and 15, 45 and 1h:45 mins after exercise session.

Study Arms (1)

Exercise intervention

EXPERIMENTAL

Subjects will undergo an acute bout of exercise for 45 mins at 75% of peak aerobic capacity

Other: Exercise bout

Interventions

Participants will exercise for 45min at 75% of VO2peak

Exercise intervention

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Age between 18-35. Body mass index (BMI) must be ≥20 and ≤26 kg/m2. HbA1c values ≤5.7%

You may not qualify if:

  • \- Age \<18 and \>35; HbA1c ≥ 5.7%; heart or lung disease; acute systemic infection accompanied by fever, body aches, or swollen lymph glands; BMI ≥ 26 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; history of keloid formation 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

    Joslin Diabetes Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

September 30, 2015

First Posted

October 1, 2015

Study Start

October 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

April 21, 2016

Record last verified: 2016-04

Locations