NCT05224986 Lifestyle Patterns and Glycemic Control
| NCT ID | NCT05224986 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | Pre-diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 34 participants |
| Start Date | 2022-01-19 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 34 participants in total. It began in 2022-01-19 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. The investigator proposes that following stable lifestyle behaviors will improve patients' glucose control, body composition, and liver fat. The results from this study has the potential to impact clinical practice and patient care.
Eligibility 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
Contact & Investigator
Marie-Pierre St-Onge
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT05224986 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, studying Pre-diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05224986 currently recruiting?
Yes, NCT05224986 is actively recruiting participants. Contact the research team at ms2554@cumc.columbia.edu for enrollment information.
Where is the NCT05224986 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05224986 clinical trial?
NCT05224986 is sponsored by Columbia University. The principal investigator is Marie-Pierre St-Onge at Columbia University. The trial plans to enroll 34 participants.
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