Lifestyle Patterns and Glycemic Control

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.

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.

Interventions

• Behavioral Fixed Schedule
  Participants will be asked to maintain a fixed schedule for 12 weeks.

Primary outcome measures

• Adipose Tissue Measurement - Total [Time frame: 12 weeks]
• Adipose Tissue Measurement - Subcutaneous [Time frame: 12 weeks]
• Adipose Tissue Measurement - Visceral [Time frame: 12 weeks]
• Glucose Area Under Curve [Time frame: 12 weeks]
• Mean Amplitude of Glycemic Excursion and Standard Deviation of Mean Glucose [Time frame: 12 weeks]

Secondary outcome measures (7)

• Liver Fat Content [Time frame: 12 weeks]
• Disposition Index [Time frame: 12 weeks]
• Short-term Change in Glycemia [Time frame: Baseline, up to 12 weeks]
• Endothelial cell inflammation (sub-set, n≤10) [Time frame: Baseline, 12 weeks]
• White blood cells [Time frame: Baseline, 12 weeks]
• Long-term Change in Glycemia [Time frame: Baseline, 12 weeks]
• Endothelial cell oxidative stress (sub-set, n≤10) [Time frame: Baseline, 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

United States · 1 center

• Columbia University Irving Medical Center — New York

Identifiers

NCT: NCT05224986 · AAAT8914 · R01DK128154

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗