Status:
RECRUITING
Lifestyle Patterns and Glycemic Control
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Department of Health and Human Services
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Pre-diabetes
Eligibility:
All Genders
25+ years
Phase:
NA
Brief Summary
The goal of the proposed study is to evaluate the feasibility and initial efficacy of stabilizing lifestyle behaviors to improve glucose control and body composition in patients with pre-diabetes. Th...
Detailed Description
Variability in lifestyle behaviors has been associated with adverse health, specifically poor glucose control. The project proposes to test whether reducing this variability improves glycemia in patie...
Eligibility Criteria
Inclusion
- Pre-diabetic kg/m2 (hemoglobin A1c 5.7-6.9%)
- 25 years or older
- BMI between 25-39.9 kg/m2
- Sleep duration ≥6 hours a night assessed with wrist actigraphy (for 14 nights)
- Variable bedtime, SD≥45 minutes.
Exclusion
- Chronic Kidney Disease (GFR\<60)
- Uncontrolled hypertension (≥160/100 mmHg)
- Obstructive Sleep Apnea
- Psychiatric or neurological disorder
- Prevalent cardiovascular disease
- Dyslipidemia (triglycerides≥200 mg/dL)
- Medications that affect insulin sensitivity, glucose concentrations, and body weight
- Non-day or rotating shift workers
- Travel across time zones
- Active participation in weight loss program or within past 3 months
- Current or past alcohol/drug abuse
Key Trial Info
Start Date :
January 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT05224986
Start Date
January 19 2022
End Date
June 1 2026
Last Update
July 8 2025
Active Locations (1)
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1
Columbia University Irving Medical Center
New York, New York, United States, 10032