Lifestyle Patterns and Glycemic Control

NCT05224986 | Recruiting

• 2 other identifiers: AAAT8914R01DK128154
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Pre-diabetes

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• Liver Fat Content

  12 weeks

• Disposition Index

  12 weeks

• Short-term Change in Glycemia

  Baseline, up to 12 weeks

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

  Baseline, 12 weeks

• White blood cells

  Baseline, 12 weeks

Study Arms (2)

Variable Schedule

NO INTERVENTION

Participants randomized to Variable Schedule (VS) will be asked to maintain their usual habits for 12 weeks.

Fixed Schedule

EXPERIMENTAL

Participants randomized to Fixed Schedule (FS) will be asked to stabilize their lifestyle behaviors for 12 weeks.

Behavioral: Fixed Schedule

Interventions

Fixed Schedule BEHAVIORAL

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

Fixed Schedule

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pre-diabetic kg/m2 (hemoglobin A1c 5.7-6.9%)
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• Department of Health and Human Services: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Marie-Pierre St-Onge

  Columbia University

  PRINCIPAL INVESTIGATOR

• Blandine Laferrere

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Pierre St-Onge

CONTACT

212-851-5578; ms2554@cumc.columbia.edu

Lena Navarro

CONTACT

347-963-8845; lrn2116@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants will not be blinded to the intervention or purpose of the study but will be told that rest-activity patterns will be examined in the context of well-being and that we will test the influence of these lifestyle patterns on glucose control and body composition. Although the investigators and research assistant directly involved in the conduct of the study cannot be blinded to participant assignment to the intervention or control group, the technicians involved in sample processing and the biostatistician (Dr. Cheng) will be blinded to this information to reduce the risk of bias.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Nutritional Medicine

Model Details: A randomized, parallel-arm clinical intervention study to assess the role of variability in lifestyle behaviors on glucose control and body composition in adults with pre-diabetes. The goal is to test whether following a fixed schedule improves glucose control and insulin sensitivity and reduces adiposity compared to those who maintain a variable schedule.

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 4, 2022
• Study Start: January 19, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)