Recruiting

Glycemic Control

Sponsor:

Columbia University

Code:

NCT05224986

Conditions

Pre-diabetes

Eligibility Criteria

Sex: All

Age: 25+

Healthy Volunteers: Not accepted

Interventions

Fixed Schedule

Study Details

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.

Conditions

Pre-diabetes

Study ID

NCT05224986

Start date

Jan 19, 2022

Status verified date

Jan, 2026

Completion date

Jul 31, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

34 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: Variable Schedule

Participants randomized to Variable Schedule (VS) will be asked to maintain their usual habits for 12 weeks.

experimental: Fixed Schedule

Participants randomized to Fixed Schedule (FS) will be asked to stabilize their lifestyle behaviors for 12 weeks.

Interventions

Fixed Schedule

Participants will be asked to maintain a fixed schedule for 12 weeks.

Primary outcome measure

  • Adipose Tissue Measurement - Total [ Time Frame: 12 weeks ]
  • Adipose Tissue Measurement - Subcutaneous [ Time Frame: 12 weeks ]
  • Adipose Tissue Measurement - Visceral [ Time Frame: 12 weeks ]
  • Glucose Area Under Curve [ Time Frame: 12 weeks ]
  • Mean Amplitude of Glycemic Excursion and Standard Deviation of Mean Glucose [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Marie-Pierre St-Onge

212-851-5578ms2554@cumc.columbia.edu

Lena Navarro

347-963-8845lrn2116@cumc.columbia.edu

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Marie-Pierre St-Onge, PhD

ms2554@cumc.columbia.edu

Lara Bond

9175814637lsb2173@cumc.columbia.edu

Principal Investigator:

Marie-Pierre St-Onge

More Information

Sponsor

Columbia University

Last update posted

Jan 28, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-01-28.