A Pilot Study on the Effects of Medically Supervised, Water-Only Fasting and Refeeding on Cardiometabolic Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Changes in insulin resistance from baseline
研究概览
简要总结
This pilot study is designed to investigate the effect of water-only fasting and refeeding on the homeostatic model of insulin resistance (HOMA-IR), a measure of insulin resistance.
详细描述
Ischemic stroke is a leading cause of death and a major public health burden. Data suggests that insulin resistance is a potential risk factor for cardiovascular disease, including ischemic stroke, and that dietary and lifestyle intervention can reduce insulin resistance as well as these disease risks. Nonetheless, current intervention strategies have done little to reduce overall stroke incidence. Therefore, an intervention, such as prolonged medically supervised water-only fasting, might be an effective strategy to both reduce insulin resistance and encourage dietary and lifestyle changes that reduce incidence of stroke.
This pilot study is designed to investigate the effect of water-only fasting and refeeding on the homeostatic model of insulin resistance (HOMA-IR), a measure of insulin resistance. Additionally, the study will assess if markers of cardiovascular health and inflammation change before and after water-only fasting. Water-only fasting participants will be recruited from patients who voluntarily elect to water-only fast for 10 or more consecutive days. Clinical variables and blood will be collected at baseline, every 7th day during fasting and refeeding, and the final day of fasting and refeeding.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any gender
- •40-70 years old
- •Fasting plasma glucose <12 6mg/dL and/or hemoglobin A1c <7%
- •Body Mass Index (BMI) >25 kg/m2
- •Elect and qualify for a water-only fast of at least 10 consecutive days
- •Provide informed consent
排除标准
- •Active malignancy
- •Active inflammatory disorder including classic autoimmune connective tissue (Lupus, Sjogrens, ANCA), multiple sclerosis, and inflammatory bowel disorders (Ulcerative colitis, Crohn's)
- •Stroke or heart attack within the last 90 days
结局指标
主要结局
Changes in insulin resistance from baseline
时间窗: Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast
Insulin resistance assessed using serum glucose and insulin to calculate homeostatic model of insulin resistance (HOMA-IR) \[fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5\]
次要结局
- Changes in weight from baseline(Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast)
- Changes in lipid profile from baseline(Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast)
- Changes in high sensitivity C-reactive protein (hsCRP) from baseline(Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast)
- Changes in resting systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline(Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast)
- Changes in abdominal circumference from baseline(Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast)