Lifestyle Patterns and Glycemic Control
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Adipose Tissue Measurement - Subcutaneous
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Variable Schedule
Participants randomized to Variable Schedule (VS) will be asked to maintain their usual habits for 12 weeks.
Fixed Schedule
Participants randomized to Fixed Schedule (FS) will be asked to stabilize their lifestyle behaviors for 12 weeks.
干预措施: Fixed Schedule (Behavioral)
结局指标
主要结局
Adipose Tissue Measurement - Subcutaneous
时间窗: 12 weeks
Measurement of subcutaneous adiposity using MRI.
Adipose Tissue Measurement - Total
时间窗: 12 weeks
Measuring total adiposity. Measured by MRI, includes both subcutaneous and visceral adipose tissue.
Adipose Tissue Measurement - Visceral
时间窗: 12 weeks
Measurement of visceral adiposity using MRI.
Mean Amplitude of Glycemic Excursion and Standard Deviation of Mean Glucose
时间窗: 12 weeks
Testing glucose variability. The primary outcome variables are mean amplitude of glucose excursion and standard deviation of average glucose.
Glucose Area Under Curve
时间窗: 12 weeks
Testing glycemic control.The primary outcome variable is glucose under the curve during the oral glucose tolerance test.
次要结局
- Liver Fat Content(12 weeks)
- Endothelial cell inflammation (sub-set, n≤10)(Baseline, 12 weeks)
- Endothelial cell oxidative stress (sub-set, n≤10)(Baseline, 12 weeks)
- White blood cells(Baseline, 12 weeks)
- Disposition Index(12 weeks)
- Short-term Change in Glycemia(Baseline, up to 12 weeks)
- Long-term Change in Glycemia(Baseline, 12 weeks)
研究者
Marie-Pierre St-Onge
Associate Professor of Nutritional Medicine
Columbia University