Lifestyle Patterns and Glycemic Control

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (7)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Columbia University Irving Medical Center — New York

Идентификаторы

NCT: NCT05224986 · AAAT8914 · R01DK128154

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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