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Lifestyle Patterns and Glycemic Control

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Columbia University

Status

Enrolling

Conditions

Pre-diabetes

Treatments

Behavioral: Fixed Schedule

Study type

Interventional

Funder types

Other
Other U.S. Federal agency
NIH

Identifiers

NCT05224986
R01DK128154 (U.S. NIH Grant/Contract)
AAAT8914

Details and patient eligibility

About

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.

Full 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.

Enrollment

34 estimated patients

Sex

All

Ages

25+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

34 participants in 2 patient groups

Variable Schedule
No Intervention group
Description:
Participants randomized to Variable Schedule (VS) will be asked to maintain their usual habits for 12 weeks.
Fixed Schedule
Experimental group
Description:
Participants randomized to Fixed Schedule (FS) will be asked to stabilize their lifestyle behaviors for 12 weeks.
Treatment:
Behavioral: Fixed Schedule

Trial contacts and locations

1

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Central trial contact

Lena Navarro; Marie-Pierre St-Onge

Data sourced from clinicaltrials.gov

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