Image

Lifestyle Patterns and Glycemic Control

Lifestyle Patterns and Glycemic Control

Recruiting
25 years and older
All
Phase N/A

Powered by AI

Overview

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.

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.

Eligibility

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 details
    Pre-diabetes

NCT05224986

Columbia University

14 May 2026

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.