Status:
COMPLETED
Feasibility of a Partnered Approach to Prevent Diabetes
Lead Sponsor:
Northwestern University
Conditions:
Pre-diabetic State
Overweight
Eligibility:
All Genders
25+ years
Phase:
NA
Brief Summary
The Diabetes Prevention Program (DPP) demonstrated that an intensive lifestyle intervention resulting in modest weight loss and increased physical activity can delay or prevent the development of type...
Eligibility Criteria
Inclusion
- 25 years of age or older Body-mass index of \>= 24 kg/m2
- or more additional risk factors if age is \<45
- \- Parent or sibling with diabetes
- Minority race or ethnicity
- History of gestational diabetes
- Delivery of infant \>= 9 lbs.
- History of high blood pressure
- History of dyslipidemia
- Polycystic Ovarian Syndrome
- History of vascular disease Fasting Capillary Glucose 95 - 125 mg/dl 2-hour Post-challenge Capillary Glucose 140 - 199 mg/dl
Exclusion
- Diseases that could limit lifespan or increase risk with a lifestyle intervention - Cancer diagnosed in the past 5 years
- \- Significant Cardiovascular Disease
- \- A "Yes" response to any item on the modified Physical Activity Readiness Questionnaire
- \- Uncontrolled hypertension: systolic blood pressure \>180 mmHg or diastolic blood pressure \>105 mmHg
- Heart attack, stroke, or transient ischemic attack within 6 months
- Chest pain or unexplained dizziness or fainting with physical exertion
- Chronic obstructive pulmonary disease or asthma needing home oxygen
- Other chronic disease or condition, such as advanced arthritis, that could limit ability to become physically active or limit life span to \<5 years
- Any other known reason for not participating in regular physical activity
- Exclusions related to metabolism - Past anti-diabetes medication use, except during gestational diabetes
- \- Use of a medications known to produce hyperglycemia
- \- Known disease leading to abnormal glucose metabolism
- Exclusions for conditions / behaviors likely to affect study conduct
- \- Unable or unwilling to provide informed consent
- Unable to communicate with the pertinent clinic staff
- Unable to read written English or Spanish
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00302055
Start Date
March 1 2006
End Date
July 1 2007
Last Update
December 1 2016
Active Locations (2)
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1
IU Medical Group Westside Clinic
Indianapolis, Indiana, United States, 46222
2
IU Medical Group Banta Road Clinic
Indianapolis, Indiana, United States, 46227