Lifestyle Patterns and Glycemic Control

Study Overview
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Brief Summary
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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
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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.

Official Title
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Lifestyle Patterns and Glycemic Control

Conditions
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Pre-diabetes

Intervention / Treatment
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* Behavioral: Fixed Schedule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pre-diabetic kg/m2 (hemoglobin A1c 5.7-6.4%) 35 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

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 
| Endothelial cell inflammation (sub-set, n≤10) | NF-κB nuclear fluorescence area for pilot study. | Baseline, 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 oxidative stress (sub-set, n≤10) | redox sensitive fluorogenic probe fluorescence intensity for pilot study. | Baseline, 12 weeks |