NCT00766298

Brief Summary

102 late- life adults at risk for developing type 2 diabetes mellitus, will be randomized to one of three interventions designed to improve insulin sensitivity thereby potentially preventing future progression of type 2 diabetes. The investigators predict that insulin sensitivity will improve equally following either weight loss or exercise, while there will be additive effects from combined intervention. The investigators hypothesize that weight loss will decrease intermuscular adipose tissue, intramyocellular lipid, and visceral abdominal adipose tissue.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Jun 2004

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

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

June 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
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

July 31, 2017

Status Verified

July 1, 2017

Enrollment Period

7.2 years

First QC Date

October 2, 2008

Last Update Submit

July 26, 2017

Conditions

Type 2 Diabetes Mellitus

Keywords

ExerciseWeight LossPhysical ActivityType 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Effects of physical activity and weight loss, alone or in combination, on intramyocellular lipid, intermuscular adipose tissue and abdominal AT, oxidative capacity and insulin resistance.

    16 weeks

Secondary Outcomes (1)

  • Assess the mechanisms by which these interventions may prevent the development of diabetes

    16 weeks

Study Arms (3)

1

EXPERIMENTAL

Weight Loss

Behavioral: Weight Loss

2

EXPERIMENTAL

Exercise

Behavioral: Exercise

3

EXPERIMENTAL

Exercise and Weight Loss

Behavioral: Exercise and weight loss

Interventions

ExerciseBEHAVIORAL

16 week intervention; 6 exercise sessions weekly w 3 supervised exercise sessions weekly utilizing cycling or walking/jogging. Participants maintain exercise diaries: wks 1-4; 30 minutes at 60-70% MHR, wks 5-8; 40 minutes at 60-70% MHR, weeks 9-16; 40 minutes at 75% MHR

2
Weight LossBEHAVIORAL

The reduction of kcal/day through implementation of low fat diet

1
Exercise and weight lossBEHAVIORAL

Exercise: 16 week intervention; 6 exercise sessions weekly w 3 supervised exercise sessions weekly utilizing cycling or walking/jogging. Participants maintain exercise diaries: wks 1-4; 30 minutes at 60-70% MHR, wks 5-8; 40 minutes at 60-70% MHR, weeks 9-16; 40 minutes at 75% MHR. Weight Loss: Reduction of kcal/day through implementation of a low fat diet.

3

Eligibility Criteria

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

You may qualify if:

  • years of age
  • Stable weight (No Gain/Loss of \> 10 lbs in 6 months)
  • Impaired Glucose Tolerance or Newly, untreated, undiagnosed type 2 diabetes
  • Sedentary
  • Non-smoker
  • BMI 25.0-38.0 KG/M2
  • Resting Blood Pressure ≤ 150mmHg systolic and ≤ 95 mmHg diastolic
  • IGT: Fasting Glucose \> 100, \< 126 2-Hour OGTT \> 140 but \< 200
  • T2D: Fasting Glucose \> 126 \< 2000 2-Hour OGTT \> 200
  • 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 VO2 max pre-training value \> 55 ml/kg-fat free mass-min., indicative of moderate fitness.
  • Anemia (Hematocrit \< 34%)
  • Any contraindications to moderate exercise (Please specify)
  • Inability and/ or unwillingness 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
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (6)

  • Amati F, Dube JJ, Coen PM, Stefanovic-Racic M, Toledo FG, Goodpaster BH. Physical inactivity and obesity underlie the insulin resistance of aging. Diabetes Care. 2009 Aug;32(8):1547-9. doi: 10.2337/dc09-0267. Epub 2009 Apr 28.

    PMID: 19401446RESULT

  • Amati F, Dube JJ, Shay C, Goodpaster BH. Separate and combined effects of exercise training and weight loss on exercise efficiency and substrate oxidation. J Appl Physiol (1985). 2008 Sep;105(3):825-31. doi: 10.1152/japplphysiol.90384.2008. Epub 2008 Jul 10.

    PMID: 18617627RESULT

  • Amati F, Dube JJ, Stefanovic-Racic M, Toledo FG, Goodpaster BH. Improvements in insulin sensitivity are blunted by subclinical hypothyroidism. Med Sci Sports Exerc. 2009 Feb;41(2):265-9. doi: 10.1249/MSS.0b013e318187c010.

    PMID: 19127201RESULT

  • Amati F, Pennant M, Azuma K, Dube JJ, Toledo FG, Rossi AP, Kelley DE, Goodpaster BH. Lower thigh subcutaneous and higher visceral abdominal adipose tissue content both contribute to insulin resistance. Obesity (Silver Spring). 2012 May;20(5):1115-7. doi: 10.1038/oby.2011.401. Epub 2012 Jan 19.

    PMID: 22262160RESULT

  • Menshikova EV, Ritov VB, Fairfull L, Ferrell RE, Kelley DE, Goodpaster BH. Effects of exercise on mitochondrial content and function in aging human skeletal muscle. J Gerontol A Biol Sci Med Sci. 2006 Jun;61(6):534-40. doi: 10.1093/gerona/61.6.534.

    PMID: 16799133RESULT

  • Dube JJ, Amati F, Toledo FG, Stefanovic-Racic M, Rossi A, Coen P, Goodpaster BH. Effects of weight loss and exercise on insulin resistance, and intramyocellular triacylglycerol, diacylglycerol and ceramide. Diabetologia. 2011 May;54(5):1147-56. doi: 10.1007/s00125-011-2065-0. Epub 2011 Feb 17.

    PMID: 21327867DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Motor ActivityWeight Loss

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehaviorBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

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
Professor

Study Record Dates

First Submitted

October 2, 2008

First Posted

October 3, 2008

Study Start

June 1, 2004

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

July 31, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)