Actively Recruiting

Phase Not Applicable
Age: 25Years +
All Genders
NCT05224986

Lifestyle Patterns and Glycemic Control

Led by Columbia University · Updated on 2026-01-28

34

Participants Needed

1

Research Sites

236 weeks

Total Duration

On this page

Sponsors

C

Columbia University

Lead Sponsor

D

Department of Health and Human Services

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Lifestyle Patterns and Glycemic Control

Who Can Participate

Age: 25Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with pre-diabetes (hemoglobin A1c 5.7-6.9%)
  • 25 years or older
  • Body mass index (BMI) between 25 and 39.9 kg/m2
  • Sleep at least 6 hours per night, measured over 14 nights with wrist actigraphy
  • Variable bedtime with a standard deviation of 45 minutes or more
Not Eligible

You will not qualify if you...

  • Chronic kidney disease with glomerular filtration rate (GFR) less than 60
  • Uncontrolled high blood pressure (160/100 mmHg or higher)
  • Obstructive sleep apnea
  • Psychiatric or neurological disorders
  • Existing cardiovascular disease
  • Dyslipidemia with triglycerides 200 mg/dL or higher
  • Use of medications affecting insulin sensitivity, glucose levels, or body weight
  • Working non-day or rotating shifts
  • Recent travel across time zones
  • Active or recent (within 3 months) participation in a weight loss program
  • Current or past alcohol or drug abuse

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Columbia University Irving Medical Center

New York, New York, United States, 10032

Actively Recruiting

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Research Team

M

Marie-Pierre St-Onge

CONTACT

L

Lena Navarro

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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