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NCT Number: NCT05224986

Lifestyle Patterns and Glycemic Control

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.

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Key information

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

Location status: Recruiting

Location contact

Lara Bond

CONTACT

[email protected]

9175814637

Marie-Pierre St-Onge

PRINCIPAL_INVESTIGATOR

Marie-Pierre St-Onge, PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fixed Schedule

Behavioral

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

Primary outcomes

  1. Adipose Tissue Measurement - Total

    Time frame: 12 weeks

    Measuring total adiposity. Measured by MRI, includes both subcutaneous and visceral adipose tissue.

  2. Adipose Tissue Measurement - Subcutaneous

    Time frame: 12 weeks

    Measurement of subcutaneous adiposity using MRI.

  3. Adipose Tissue Measurement - Visceral

    Time frame: 12 weeks

    Measurement of visceral adiposity using MRI.

  4. Glucose Area Under Curve

    Time frame: 12 weeks

    Testing glycemic control.The primary outcome variable is glucose under the curve during the oral glucose tolerance test.

  5. Mean Amplitude of Glycemic Excursion and Standard Deviation of Mean Glucose

    Time frame: 12 weeks

    Testing glucose variability. The primary outcome variables are mean amplitude of glucose excursion and standard deviation of average glucose.

Secondary outcomes

  1. Liver Fat Content

    Time frame: 12 weeks

    This is to assess liver fat measured by MRS and MRI in %.

  2. Disposition Index

    Time frame: 12 weeks

    This is to assess disposition index, measured using HOMA-IR. The disposition index is the product of the insulogenic index and homeostatic model of assessment for insulin resistance.

  3. Short-term Change in Glycemia

    Time frame: Baseline, up to 12 weeks

    Assessing whether short-term glycemia is changed by measuring fructosamine using two-sample t-tests.

  4. Endothelial cell inflammation (sub-set, n≤10)

    Time frame: Baseline, 12 weeks

    NF-κB nuclear fluorescence area for pilot study.

  5. White blood cells

    Time frame: Baseline, 12 weeks

    Leukocytes and neutrophils

  6. Long-term Change in Glycemia

    Time frame: Baseline, 12 weeks

    Assessing whether long-term glycemia is changed by measuring hemoglobin A1c using two-sample t-tests.

  7. Endothelial cell oxidative stress (sub-set, n≤10)

    Time frame: Baseline, 12 weeks

    redox sensitive fluorogenic probe fluorescence intensity for pilot study.

Study contacts

Contact information is provided by the study sponsor or research team.

Lena Navarro

CONTACT

[email protected]

347-963-8845

Marie-Pierre St-Onge

CONTACT

[email protected]

212-851-5578

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Department of Health and Human Services
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 4, 2022
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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