Pre-diabetes Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 34 |
Est. completion date | June 1, 2024 |
Est. primary completion date | June 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years and older |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Columbia University Irving Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University | Department of Health and Human Services, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adipose Tissue Measurement - Total | Measuring total adiposity. Measured by MRI, includes both subcutaneous and visceral adipose tissue. | 12 weeks | |
Primary | Adipose Tissue Measurement - Subcutaneous | Measurement of subcutaneous adiposity using MRI. | 12 weeks | |
Primary | Adipose Tissue Measurement - Visceral | Measurement of visceral adiposity using MRI. | 12 weeks | |
Primary | Glucose Area Under Curve | Testing glycemic control.The primary outcome variable is glucose under the curve during the oral glucose tolerance test. | 12 weeks | |
Primary | 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 | Liver Fat Content | This is to assess liver fat measured by MRS and MRI in %. | 12 weeks | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Endothelial cell inflammation (sub-set, n=10) | NF-?B nuclear fluorescence area for pilot study. | Baseline, 12 weeks | |
Secondary | White blood cells | Leukocytes and neutrophils | Baseline, 12 weeks | |
Secondary | Long-term Change in Glycemia | Assessing whether long-term glycemia is changed by measuring hemoglobin A1c using two-sample t-tests. | Baseline, 12 weeks | |
Secondary | Endothelial cell oxidative stress (sub-set, n=10) | redox sensitive fluorogenic probe fluorescence intensity for pilot study. | Baseline, 12 weeks |
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