Actively Recruiting
Lifestyle Patterns and Glycemic Control in Adults with Pre-diabetes
Led by Columbia University · Updated on 2026-01-28
34
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
D
Department of Health and Human Services
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether stabilizing lifestyle behaviors can help improve blood sugar control and body composition in adults with pre-diabetes. The study aims to see if keeping consistent habits affects glucose levels and liver fat, which could influence future clinical care for many adults with pre-diabetes. Participants will be randomly assigned to one of two groups: one group will continue their usual lifestyle habits for 12 weeks, while the other group will work to stabilize their lifestyle behaviors for the same period. Before the 12-week study period, all participants will track their sleep for two weeks and wear a glucose monitor. At the beginning and end of the 12 weeks, they will undergo a glucose tolerance test and have MRI scans to assess body composition and liver fat. During the study, participants will be monitored through various tests including glucose area under the curve, adipose tissue measurements, and liver fat content. Researchers will also measure changes in blood sugar control and inflammation markers. The study lasts about 14 weeks, including the initial sleep tracking, followed by the 12-week lifestyle period and final assessments.
CONDITIONS
Brief Title
Lifestyle Patterns and Glycemic Control
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 25 years or older
- Diagnosed with pre-diabetes (hemoglobin A1c 5.7-6.9%)
- Body mass index (BMI) between 25 and 39.9 kg/m2
- Sleep duration of at least 6 hours per night, measured by wrist actigraphy for 14 nights
- Variable bedtime with a standard deviation of 45 minutes or more
You will not qualify if you...
- Chronic kidney disease with GFR less than 60
- Uncontrolled high blood pressure (160/100 mmHg or higher)
- Obstructive sleep apnea
- Psychiatric or neurological disorders
- Existing cardiovascular disease
- High triglycerides (200 mg/dL or higher)
- Use of medications affecting insulin sensitivity, glucose levels, or body weight
- Non-day or rotating shift work
- Recent travel across time zones
- Active participation in a weight loss program currently or within the past 3 months
- Current or past alcohol or drug abuse
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) to confirm eligibility and baseline measurements
Duration - 2 weeks
Participants track their sleep and wear a glucose monitor to measure glucose levels before the intervention period. They also undergo glucose tolerance testing and MRI scans to assess body composition and liver fat content.
1 visit at the start for glucose tolerance test and MRI scanning
Duration - 12 weeks
Participants are randomized to either maintain their usual lifestyle habits or stabilize their behaviors for 12 weeks.
Weekly visits for monitoring and support throughout the 12-week period
Duration - 1 week
At the end of the 12-week period, participants undergo repeat glucose tolerance testing and MRI scans to assess changes in glucose control and body composition.
1 visit (in-person) for final assessments
Trial Site Locations
Total: 1 location
1
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
Research Team
M
Marie-Pierre St-Onge
L
Lena Navarro
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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