Improving glucose control through stable lifestyle behaviors
Lifestyle Patterns and Glycemic Control
NA · Columbia University · NCT05224986
This study is testing if changing daily habits can help people with pre-diabetes better control their blood sugar and improve their body composition over 12 weeks.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 25 Years and up |
| Sex | All |
| Sponsor | Columbia University (other) |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05224986 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility and initial efficacy of stabilizing lifestyle behaviors to enhance glucose control and body composition in individuals with pre-diabetes. Participants will be randomized into two groups: one maintaining their usual habits and the other focusing on stabilizing their behaviors over a 12-week period. Prior to this, all participants will track their sleep and wear a glucose monitor to assess their glucose levels. The study will also include glucose tolerance tests and imaging to analyze body composition and liver fat content.
Who should consider this trial
Good fit: Ideal candidates are adults aged 25 and older with pre-diabetes and erratic lifestyle behaviors.
Not a fit: Patients with chronic kidney disease, uncontrolled hypertension, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve glucose control and overall health for patients with pre-diabetes.
How similar studies have performed: Other studies have shown that lifestyle interventions can positively impact glycemic control, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
New York, New York
- Columbia University Irving Medical Center — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Marie-Pierre St-Onge — Columbia University
- Study coordinator: Marie-Pierre St-Onge
- Email: ms2554@cumc.columbia.edu
- Phone: 212-851-5578
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pre-diabetes