NCT01452087

Brief Summary

Compare the effects of single session of exercise vs. chronic exercise training on key risk factors associated with Metabolic Syndrome (e.g., glucose tolerance, blood lipid profile, and blood pressure) in overweight adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started May 2009

Longer than P75 for not_applicable obesity

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

May 1, 2009

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

October 11, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 14, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

November 24, 2014

Status Verified

November 1, 2014

Enrollment Period

4.8 years

First QC Date

October 11, 2011

Last Update Submit

November 20, 2014

Conditions

Keywords

insulin sensitivityexercise

Outcome Measures

Primary Outcomes (1)

  • oral glucose tolerance test

    2 hour

Secondary Outcomes (1)

  • Resting Metabolic Rate

    20-30 min

Study Arms (1)

Exercise Session

OTHER

Subjects will exercise on a treadmill for 1 hour at moderate intensity (i.e., 90% of the exercise intensity found to elicit their ventilatory threshold during the preliminary testing, which is equivalent to approximately 60% of their maximal predicted heart rate).

Other: Exercise

Interventions

Subjects will exercise on a treadmill for 1 hour at moderate intensity (i.e., 90% of the exercise intensity found to elicit their ventilatory threshold during the preliminary testing, which is equivalent to approximately 60% of their maximal predicted heart rate).

Exercise Session

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body Mass Index: 27-34 kg/m2;
  • Regular exercisers(≥4 days/wk of aerobic exercise;
  • min/session at moderate and vigorous intensities);
  • Non-exercisers (no regularly planned exercise/physical activity);
  • Women must have regularly occurring menses and must be premenopausal.

You may not qualify if:

  • Pregnant or lactating;
  • Evidence/history of cardiovascular or metabolic disease;
  • Currently taking medications known to affect lipid or glucose metabolism.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Substrate Metabolism Laboratory

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

ObesityInsulin ResistanceMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jeffrey F Horowitz, Ph.D.

    University of Michigan

    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
Associate Professor, Movement Science, School of Kinesiology

Study Record Dates

First Submitted

October 11, 2011

First Posted

October 14, 2011

Study Start

May 1, 2009

Primary Completion

February 1, 2014

Study Completion

October 1, 2014

Last Updated

November 24, 2014

Record last verified: 2014-11

Locations