NCT00765505

Brief Summary

This project will provide novel information concerning the ability of exercise to enhance the capacity for oxidative metabolism of fatty acids and improve insulin resistance in older adults who are at high risk for the development of type 2 diabetes. Ultimately this may help identify mechanisms and therapeutic targets implicated in skeletal muscle metabolic dysregulation. The proposed study is to conduct a randomized controlled exercise training intervention trial in older men and women. In addition, the response to exercise in these subjects will be compared to those of highly endurance-trained, age-matched athletes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jul 2004

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

July 1, 2004

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 3, 2008

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

February 6, 2018

Status Verified

February 1, 2018

Enrollment Period

13.5 years

First QC Date

October 2, 2008

Last Update Submit

February 3, 2018

Conditions

Obesity

Keywords

Insulin ResistanceObesityExercise TrainingPhysical Activity

Outcome Measures

Primary Outcomes (1)

  • Insulin sensitivity and muscle fat content will be measured at the beginning and the end of the intervention to determine the effects of exercise on these measures.

    16 weeks

Secondary Outcomes (1)

  • Examine if exercise-induced improvements in insulin sensitivity are similar in normal weight and in obese older subjects.

    16 weeks

Study Arms (2)

1

EXPERIMENTAL

Exercise Group

Behavioral: Exercise Group

Health Education Group

EXPERIMENTAL
Behavioral: Health Education Group

Interventions

Exercise GroupBEHAVIORAL

Sixteen week intervention where subjects will be progressed to four days per week for 45 minutes per session, 180 minutes minimum per week, of moderate intensity supervised exercise.

1
Health Education GroupBEHAVIORAL

Sixteen week intervention. This group will not receive specific exercise education or prescription but will be asked to participate in biweekly health education sessions

Health Education Group

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • No weight gain/loss of \>10 lbs in 6 months
  • Sedentary (No more than 1 continuous exercise/week) or Highly trained (\>5 exercise sessions/week for a duration of one year or more)
  • Non-Smoker
  • BMI 18-38.0
  • Resting blood pressure less than 150mmHg systolic/95 mmHg diastolic
  • Normal glucose tolerance: Fasting glucose \< 100 mg/dl or 2 hour glucose from OGTT \< 140 mg/dl or impaired glucose tolerance (fasting glucose \> 100 mg/dl \< 126 mg/dl or 2 hour glucose from OGTT \> 140 mg/dl but less than 200 mg/dl
  • Note from PCP/Cardiologist for exercise clearance if positive stress test symptoms were observed from GXT

You may not qualify if:

  • Clinically significant CVD including h/o MI
  • Peripheral Vascular Disease
  • Hepatic, renal, muscular/neuromuscular, or active hematologic/oncologic disease
  • Clinically diminished pulse
  • Presence of bruits in lower extremities
  • Previous history of pulmonary emboli
  • Peripheral Neuropathy
  • Currently not engaged in a regular program and have a V)2 max pre-training value \> 55 ml/kg-fat free mass-min., indicative of moderate fitness OR currently engaged in regular program and having a V)2 max value \< 55 ml/kg-fat free mass-min.
  • Anemia (Hematocrit \< 34%)
  • Any contraindications to moderate exercise
  • Inability and/or willingness to comply with the protocol as written
  • Active alcohol or substance abuse (Past 5 years)
  • Total cholesterol \> 300 mg/dL
  • Triglyceride \> 350 mg/dL
  • ALT \> 80, AST \> 80, Alk Phos \> 240
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

ObesityInsulin ResistanceMotor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Bret H. Goodpaster, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 2, 2008

First Posted

October 3, 2008

Study Start

July 1, 2004

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

February 6, 2018

Record last verified: 2018-02

Locations

US(1)