Status:
COMPLETED
Primary Care Community Partnerships to Prevent Diabetes
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Hyperglycemia
Obesity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine if providing free-of-charge access to a group-based lifestyle intervention delivered in partnership with the community is cost-effective for the prevention of...
Detailed Description
Randomized controlled trials have shown that modest lifestyle changes can prevent or delay the onset of diabetes in adults with pre-diabetes. Unfortunately, despite the increasing prevalence of pre-di...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Body-mass index of 24 kg/m2 or greater
- Fasting Blood Glucose 100 - 125 mg/dl, OR 2-hour Post-challenge Capillary Glucose 140 - 199 mg/dl
Exclusion
- Cancer requiring treatment in the past 5 years
- Uncontrolled hypertension: systolic blood pressure \>180 mmHg or diastolic blood pressure \>105 mmHg
- Heart attack, stroke, or transient ischemic attack in the past 6 months,
- Chronic obstructive airways disease or asthma requiring 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
- Pregnancy
- Existing diagnosis of diabetes mellitus
- Fasting capillary blood glucose \> 125 mg/dl
- 2-hour post-challenge capillary blood glucose \> 199 mg/dl
- History of anti-diabetic medication use (oral agents or insulin) except during gestational diabetes
- Self-report of a medication known to lead to hyperglycemia (oral steroids, antipsychotics, anti-epileptics)
- Self-report of disease associated with disordered glucose metabolism: Cushing's syndrome; acromegaly; pheochromocytoma; chronic pancreatitis
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
509 Patients enrolled
Trial Details
Trial ID
NCT00656682
Start Date
April 1 2008
End Date
August 1 2013
Last Update
March 29 2018
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611