Back to resultsLifestyle Interventions to Reduce Diabetes Risk
Primary Purpose
Glucose Intolerance, Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
exercise and diet
Sponsored by
About this trial
This is an interventional prevention trial for Glucose Intolerance focused on measuring low fat diet, aerobic exercise, impaired glucose tolerance, Japanese Americans, metabolic risk factors
Eligibility Criteria
Inclusion Criteria: Japanese American Confirmed impaired glucose tolerance Able to fill out questionnaires Exclusion Criteria: 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
Sites / Locations
- University of Washington
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00006162
First Posted
August 8, 2000
Last Updated
March 1, 2010
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT00006162
Brief Title
Lifestyle Interventions to Reduce Diabetes Risk
Official Title
Interventions to Reduce Diabetic Risk in Japanese Americans
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
October 1994 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 1999 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose Intolerance, Diabetes Mellitus, Type 2
Keywords
low fat diet, aerobic exercise, impaired glucose tolerance, Japanese Americans, metabolic risk factors
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
exercise and diet
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Japanese American
Confirmed impaired glucose tolerance
Able to fill out questionnaires
Exclusion Criteria:
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
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Lifestyle Interventions to Reduce Diabetes Risk
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