NCT01452074

Brief Summary

the investigators first aim is to determine the effect of low intensity exercise (without weight loss) on insulin sensitivity, muscle lipid metabolism, and factors regulating these processes in skeletal muscle after 1 day, 2 wks, 12 wks of training, and again after 3 days without exercise in obese adults. the investigators second aim is to determine the effect of combining low intensity exercise training with 10% weight loss on insulin sensitivity, muscle lipid metabolism, and factors regulating these processes in skeletal muscle. Although a single 40 minute session of exercise at a low exercise intensity will not improve insulin sensitivity, the investigators anticipate adaptations after two weeks of exercise training (6 session/wk; 12 session total) will improve insulin sensitivity and be accompanied by a reduction in fatty acid intermediates and a reduction in markers for pro-inflammatory activation in muscle. the investigators anticipate changes in insulin sensitivity, fatty acid partitioning, and pro-inflammatory markers the day after the last session of a 12 wk training program (without weight-loss) will be similar to that measured after 2 weeks of training. the investigators anticipate insulin sensitivity, accumulation of fatty acid intermediates, and pro-inflammatory activation will be markedly improved after 10% weight loss when measured the day after exercise. the investigators would expect the improvements in Insulin sensitivity, accumulation of fatty acid intermediates, and markers of inflammatory stress will be significantly attenuated when measured 3 days after the most recent exercise session, but beneficial effects of 10% weight loss on these metabolic endpoints will persist when compared with before weight loss.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jul 2011

Typical duration 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

July 1, 2011

Completed
3 months 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
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2014

Completed
Last Updated

March 21, 2022

Status Verified

March 1, 2022

Enrollment Period

3 years

First QC Date

October 11, 2011

Last Update Submit

March 18, 2022

Conditions

Keywords

Insulin SensitivityExercise TrainingWeight LossFat Metabolism

Outcome Measures

Primary Outcomes (1)

  • Insulin Sensitivity

    A hyperinsulinemic-euglycemic clamp will be used to assess peripheral insulin sensitivity

    2-3 hours

Secondary Outcomes (2)

  • Resting Metabolic Rate

    20-30 min

  • Meal Tolerance Test

    2-3h

Study Arms (1)

Exercise Training with Weight Loss

OTHER

During the first 12 weeks of the study, subjects will adhere to an exercise training program while maintaining their original body weight. The exercise training program will entail the following: 40min/session, \~50% of their maximal aerobic capacity (approximately 100-110 beats per min), 5-6 days/week After the first 12 weeks in the study, subjects will continue with the same exercise program, but then they will be placed on a reduced calorie diet until they lose exactly 10% of their original body weight

Other: Exercise TrainingOther: Weight Loss with continued Exercise Training

Interventions

During the first 12 weeks of the study, subjects will adhere to an exercise training program while maintaining their original body weight. The exercise training program will entail the following: 40min/session, \~50% of their maximal aerobic capacity (approximately 100-110 beats per min), 5-6 days/week

Exercise Training with Weight Loss

After the first 12 weeks in the study, subjects will continue with the same exercise program, but then they will be placed on a reduced calorie diet until they lose exactly 10% of their original body weight

Exercise Training with Weight Loss

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; All women must be pre-menopausal; Non-exerciser (no regularly planned exercise/physical activity)

You may not qualify if:

  • Hematocrit ≤ 34%; Fasting plasma glucose concentration ≥ 125 mg/dL; Weight instability ≥ ±5 lbs in past month; Taking medications known to affect lipid and/or glucose metabolism; evidence and/or history of cardiovascular or frank metabolic diseases; pregnancy or actively breast feeding

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 ResistanceWeight Loss

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jeffrey F Horowitz

    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

July 1, 2011

Primary Completion

July 18, 2014

Study Completion

July 18, 2014

Last Updated

March 21, 2022

Record last verified: 2022-03

Locations