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.

Study Overview

• Status: Recruiting
• Conditions: Pre-diabetes
• Intervention / Treatment: Behavioral: Fixed Schedule

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie-Pierre St-Onge; Phone Number: 212-851-5578; Email: ms2554@cumc.columbia.edu
• Study Contact Backup: Name: Lena Navarro; Phone Number: 347-963-8845; Email: lrn2116@cumc.columbia.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Irving Medical Center
      • Contact: Marie-Pierre St-Onge, PhD; Email: ms2554@cumc.columbia.edu
      • Contact: Lara Bond; Phone Number: 9175814637; Email: lsb2173@cumc.columbia.edu
      • Principal Investigator: Marie-Pierre St-Onge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Variable Schedule; Participants randomized to Variable Schedule (VS) will be asked to maintain their usual habits for 12 weeks.
Experimental: Fixed Schedule; Participants randomized to Fixed Schedule (FS) will be asked to stabilize their lifestyle behaviors for 12 weeks.	Behavioral: Fixed Schedule; Participants will be asked to maintain a fixed schedule for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adipose Tissue Measurement - Total	Measuring total adiposity. Measured by MRI, includes both subcutaneous and visceral adipose tissue.	12 weeks
Adipose Tissue Measurement - Subcutaneous	Measurement of subcutaneous adiposity using MRI.	12 weeks
Adipose Tissue Measurement - Visceral	Measurement of visceral adiposity using MRI.	12 weeks
Glucose Area Under Curve	Testing glycemic control.The primary outcome variable is glucose under the curve during the oral glucose tolerance test.	12 weeks
Mean Amplitude of Glycemic Excursion and Standard Deviation of Mean Glucose	Testing glucose variability. The primary outcome variables are mean amplitude of glucose excursion and standard deviation of average glucose.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver Fat Content	This is to assess liver fat measured by MRS and MRI in %.	12 weeks
Disposition Index	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.	12 weeks
Short-term Change in Glycemia	Assessing whether short-term glycemia is changed by measuring fructosamine using two-sample t-tests.	Baseline, up to 12 weeks
White blood cells	Leukocytes and neutrophils	Baseline, 12 weeks
Long-term Change in Glycemia	Assessing whether long-term glycemia is changed by measuring hemoglobin A1c using two-sample t-tests.	Baseline, 12 weeks
Endothelial cell inflammation (sub-set, n≤10)	NF-κB nuclear fluorescence area for pilot study.	Baseline, 12 weeks
Endothelial cell oxidative stress (sub-set, n≤10)	redox sensitive fluorogenic probe fluorescence intensity for pilot study.	Baseline, 12 weeks

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Department of Health and Human Services
• Investigators: Principal Investigator: Marie-Pierre St-Onge, Columbia University; Principal Investigator: Blandine Laferrere, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: January 25, 2022
• First Submitted That Met QC Criteria: January 25, 2022
• First Posted (Actual): February 4, 2022

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Hyperglycemia; Nutritional and Metabolic Diseases; Glucose Intolerance
• Other Study ID Numbers: AAAT8914; R01DK128154 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No