NCT00006162

Brief Summary

Type 2 diabetes is more frequent in Japanese Americans than in Japan or the U.S. non-Hispanic white population. This appears to be due to the effects of ''westernization'' to bring out metabolic changes that lead to diabetes. This study will look at whether increased physical activity and dietary changes will reduce or prevent the metabolic changes that lead to type 2 diabetes in Japanese Americans who have impaired glucose tolerance, a condition intermediate between normal glucose tolerance and diabetes.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Oct 1994

Longer than P75 for not_applicable

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

October 1, 1994

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 1999

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2000

Completed
Last Updated

March 2, 2010

Status Verified

March 1, 2010

First QC Date

August 8, 2000

Last Update Submit

March 1, 2010

Conditions

Glucose IntoleranceDiabetes Mellitus, Type 2

Keywords

low fat dietaerobic exerciseimpaired glucose toleranceJapanese Americansmetabolic risk factors

Interventions

exercise and dietBEHAVIORAL

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Japanese American
  • Confirmed impaired glucose tolerance
  • Able to fill out questionnaires

You may not qualify if:

  • Significant exercise-restricting disease
  • Poorly controlled hypertension
  • Psychiatric disease or dementia
  • Already on unusually restrictive diet
  • Use of hypolipidemic drugs
  • Use of tobacco
  • Abnormal blood screening tests
  • ECG evidence of ischemic heart disease at rest
  • Abnormal maximal Bruce treadmill test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Glucose IntoleranceDiabetes Mellitus, Type 2

Interventions

ExerciseDiet

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
PREVENTION
Sponsor Type
NIH

Study Record Dates

First Submitted

August 8, 2000

First Posted

August 9, 2000

Study Start

October 1, 1994

Study Completion

April 1, 1999

Last Updated

March 2, 2010

Record last verified: 2010-03

Locations

US(1)