Status:
COMPLETED
Evaluation of Group Lifestyle Balance Maintenance Strategies
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Robert C. Atkins Foundation
Conditions:
Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Heart disease is a leading cause of death in people in the United States. It is a major problem for those with diabetes. Conditions called the metabolic syndrome and pre-diabetes increase risk for dia...
Detailed Description
Objective: To determine the effectiveness of the Group Lifestyle Balance (GLB) program with an added maintenance component focusing on carbohydrate reduction and hunger management when compared to the...
Eligibility Criteria
Inclusion
- Non-diabetic patients with metabolic syndrome AND/OR pre-diabetes are eligible for this project based on the following criteria:
- Metabolic Syndrome:
- Patients with BMI ≥ 25 kg/m2, with at least 3 of the following risk factors for metabolic syndrome:
- Waist circumference (\>40 inches men, \>35 inches women)
- Blood pressure ≥130 mmHg (systolic) or ≥85 mmHg (diastolic) OR history of diagnosed hypertension
- Low HDL level (\<40mg/dL men, \<50 mg/dL women)
- Elevated triglyceride level ≥150 mg/dL
- Fasting glucose ≥100mg/dL and \<126mg/dL
- Pre-diabetes:
- Patients with a BMI ≥25 kg/m2 and pre-diabetes (fasting glucose ≥100 mg/dL and \<126mg/dL)
- All measures should have been taken within one year of enrollment into the study. A permission for physical activity form must be signed by the participant's physician in order to take part in the study.
Exclusion
- Previous diabetes or diabetes diagnosed as a result of the screening
- Age \<18 years old
- Women who are currently (or within past 6-weeks) pregnant or lactating
- Any patient deemed by their physician not to be a candidate
- Any patient planning to leave the area before the end of the GILS
- Any patient who is unable to provide informed consent
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00869609
Start Date
March 1 2009
End Date
August 1 2010
Last Update
June 24 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Diabetes Prevention Support Center
Pittsburgh, Pennsylvania, United States, 15213