Virtual Translation of Diabetes Prevention to Primary Care: A Pilot Study

University of Rochester2 sites in 1 country36 target enrollmentDecember 2008

ConditionsDiabetes Prevention

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetes Prevention
Sponsor: University of Rochester
Enrollment: 36
Locations: 2
Primary Endpoint: The primary outcome measure is weight loss with a goal of 7% of initial weight.
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This pilot study is intended to demonstrate that we can actually deliver the Diabetes Prevention Program intervention well and to show that it is likely effective. We will use results from this pilot study to support our application to The National Institute of Health. NIH is asking for health care centers to show ways to provide this treatment at a reasonable cost. We propose to demonstrate successful and sustainable use DPP's lifestyle intervention in a primary care health care setting (University of Rochester Primary Care).

Registry

clinicaltrials.gov

Start Date

December 2008

End Date

October 2009

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Rochester

Responsible Party

Principal Investigator

Geoffrey Williams

Professor

University of Rochester

Eligibility Criteria

Inclusion Criteria

•Age \>18 years
•BMI \>24 kg/m2 (\>22 kg/m2 among Asian Americans)
•IGT (2-h plasma glucose 140\~199 mg/dl based on 75-g OGTT if available). The OGTT will not be required for inclusion, but the CMA practitioners may wish to recommend the OGTT for their patients.
•Elevated FPG (95\~125 mg/dl\*).
•HDL-triglyceride ration \> 3.5.

Exclusion Criteria

•Diabetes at baseline
•FPG \>126 mg/dl\*
•2-h plasma glucose \>200 mg/dl based on 75-g OGTT, if available. OGTT will not be required (see above note).
•Diabetes diagnosed by a physician and confirmed by other clinical data, other than during pregnancy.
•Ever used antidiabetic medication, other than during pregnancy
•Medical conditions likely to limit life span and/or increase risk of intervention
•Cardiovascular disease
•Hospitalization for treatment of heart disease in past 6 months New York Heart Association Functional Class\> 2
•Left bundle branch block or third degree AV block Aortic stenosis
•Systolic blood pressure\> 180 mmHg or diastolic blood pressure\> 105 mmHg

Outcomes

Primary Outcomes

The primary outcome measure is weight loss with a goal of 7% of initial weight.

Time Frame: 6 months

Secondary Outcomes

;Fat intake less than 25% and saturated fat less than 10% Fiber intake of at least 25 grams per day;Fasting blood sugar < 100 mg/dL; Absence of tobacco use(6 months)
Exercising a minimum of 150 minutes per week at a moderate level to maintain an energy expenditure of 700 kcals per week(6 months)