Lifestyle Patterns and Glycemic Control

Last updated: July 2, 2025
Sponsor: Columbia University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes (Pediatric)

Treatment

Fixed Schedule

Clinical Study ID

NCT05224986
AAAT8914
R01DK128154
  • Ages > 25
  • All Genders

Study 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

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

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

Total Participants: 34
Treatment Group(s): 1
Primary Treatment: Fixed Schedule
Phase:
Study Start date:
January 19, 2022
Estimated Completion Date:
June 01, 2026

Study 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 patients with pre-diabetes. If successful, this simple positive lifestyle message to keep stable behaviors has the potential to improve the health of millions of adults worldwide.

This project will enroll participants with pre-diabetes who have erratic lifestyle behaviors and randomize them to either maintain their usual habits (control group) or stabilize their behaviors (stability group). Both groups will be followed for 12 weeks. Before the start of the 12-week period, all participants will track their sleep for 2 weeks and will wear a glucose monitor to measure their glucose levels. At the start and end of the 12-week period, they will come to the research lab to undergo a glucose tolerance test. This test will measure how their body reacts to a glucose load. They will also undergo magnetic resonance imaging and spectroscopy scanning. This scan will provide information on body composition and liver fat content.

Connect with a study center

  • Columbia University Irving Medical Center

    New York, New York 10032
    United States

    Active - Recruiting

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