NCT00382473

Brief Summary

The purpose of this study is to compare the effects of an 8-week aerobic training program upon fat oxidation in vivo and markers of skeletal muscle mitochondrial content and oxidative capacity in sedentary obese subjects with and without type 2 diabetes. We will also investigate if mitochondrial content in muscle predicts success of weight loss. The specific aims are:

  • To compare systemic fat oxidation rates;
  • To measure mitochondrial content in muscle before and after aerobic training;
  • To determine if decreased mitochondrial content is also associated with decreased mitochondrial oxidative capacity;
  • To measure non-plasma fatty acid oxidation in vivo during submaximal exercise conditions both prior and after aerobic training;
  • To determine whether increases in fat oxidation due to physical activity predict weight loss success when a reduced calorie diet is added to a physical activity program.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Sep 2006

Longer than P75 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 29, 2006

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

April 25, 2014

Status Verified

April 1, 2014

Enrollment Period

4.3 years

First QC Date

September 28, 2006

Last Update Submit

April 24, 2014

Conditions

Diabetes Mellitus, Type 2Overweight

Keywords

Diabetes Mellitus, Type 2OverweightFatty acid oxidationMitochondriaExercise

Outcome Measures

Primary Outcomes (1)

  • The degree of improvement in fat oxidation during submaximal exercise obtained by indirect calorimetry after subjects have completed an eight week aerobic exercise program.

    8 weeks

Secondary Outcomes (3)

  • The degree of improvement in muscle mitochondrial content after eight week exercise program.

    8 weeks

  • The amount of improvement in muscle mitochondrial oxidative capacity after eight week exercise program.

    8 weeks

  • Increase in fat oxidation from non-plasma sources after the eight week intervention.

    8 weeks

Study Arms (1)

exercise

EXPERIMENTAL
Behavioral: Aerobic exercise program - 8 weeks

Interventions

Aerobic exercise program - 8 weeksBEHAVIORAL

No drugs. Regular aerobic exercise in structured prescription format

exercise

Eligibility Criteria

Age28 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men and women, aged 28-55 year-old, in general good health and with no contraindications to exercise. We are recruiting three groups of subjects: Group 1: overweight/obese adults with type 2 diabetes, with a BMI between 28-40. Group 2: overweight/obese adults without type 2 diabetes, with a BMI between 28-40. Group 3: adults without type 2 diabetes, with a BMI equal or less than 25 (not overweight/obese.)

You may not qualify if:

  • Any condition that does not permit exercise; current participation in a regular physical activity; uncontrolled blood pressure; treatment with any of the following medications: insulin, any weight-loss drug, oral glucocorticoids, or any drugs that affect muscle and fat metabolism such as niacin, fibrates, and beta blockers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh, Montefiore Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2OverweightMotor Activity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Frederico G Toledo, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2006

First Posted

September 29, 2006

Study Start

September 1, 2006

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

April 25, 2014

Record last verified: 2014-04

Locations

US(1)