NCT01452035

Brief Summary

Many of the beneficial metabolic effects of endurance exercise training are not due to adaptations to weeks, months, or even years of training, but rather much is due to the response to the most recent exercise session(s). Therefore, the investigators contend that lifestyle interventions for obese individuals should be tailored to optimize the metabolic effects of the most recent exercise session(s). But the "dose" of exercise necessary to evoke these beneficial responses is not known, and the mechanisms responsible for these improvements are poorly understood. The findings from these studies will: 1) establish the minimum "dose" of a single exercise session necessary to improve insulin sensitivity the next day in obese adults, 2) characterize the underlying metabolic factors responsible for the improvement in insulin sensitivity, and 3) assess the cumulative metabolic adaptations that occur over days, weeks, and months of a low-intensity/low-volume lifestyle exercise program. Findings from these studies will provide valuable information for the development of lifestyle programs aimed at maximizing the key metabolic health benefits of each exercise session in obese patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jan 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

January 1, 2009

Completed
2.8 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
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

November 8, 2016

Status Verified

November 1, 2016

Enrollment Period

6.4 years

First QC Date

October 11, 2011

Last Update Submit

November 7, 2016

Conditions

Keywords

insulin sensitivityfatty acid metabolismexercise

Outcome Measures

Primary Outcomes (1)

  • Insulin Sensitivity

    A hyperinsulinemic-euglycemic clamp will be used to assess peripheral insulin sensitivity and will be performed using a primed 2h insulin infusion at a rate of 100 mU/m2/min.

    2-3 hours

Secondary Outcomes (2)

  • Resting Metabolic Rate

    40-60 min

  • Meal Tolerance Test

    2-3h

Study Arms (2)

Exercise

EXPERIMENTAL
Other: Exercise

Sedentary Control

NO INTERVENTION

Interventions

single session of exercise

Exercise

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body Mass Index \[BMI\] = 30-45 kg/m2, weight stable (± 5 lbs in the past month), fasting blood glucose concentration must be \<125 mg/dl.

You may not qualify if:

  • pregnancy, evidence of cardiovascular or metabolic disease, taking medications know to influence metabolism.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michigan Clincal Research Unit

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
RANDOMIZED
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

January 1, 2009

Primary Completion

June 1, 2015

Study Completion

December 1, 2015

Last Updated

November 8, 2016

Record last verified: 2016-11

Locations