NCT01792986已完成不适用
Preparatory Study to Determine Which Risk Markers May be Reduced by Fasting and Should be Evaluated in a Future Randomized Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Difference in Mean Glucose Level Between Baseline and the End of the Sixth Week.
研究概览
简要总结
This study will determine whether an intensive fasting protocol alters hemoglobin A1c measurements or other markers of metabolic and cardiovascular risk by performing a 5-week clinical trial of fasting among 12 pre-diabetic individuals or diabetics whose disease is controlled by diet. Participants will undergo a 5-week intervention of once-per-week 24-hour water-only fasting, including at baseline and at the end of the week for each week of the study (a total of 6 24-hour fasts).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant female, ≥30 and <70 years of age.
- •Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.
- •Prior evidence of pre-diabetic state, with one of the following:
- •Pre-diabetic with a measured hemoglobin A1c (HbA1c) ≥6.0% or fasting glucose >100 mg/dL without a clinical diabetes diagnosis
- •Clinically-diagnosed type II diabetic with HbA1c ≥6.0% or fasting glucose ≥110 mg/dL and whose disease is controlled by diet alone.
- •Evidence of metabolic syndrome by having at least 3 of the following 5 criteria:
- •Fasting glucose level >100 mg/dL.
- •Blood pressure ≥135 mmHg systolic or ≥85 mmHg diastolic, or use of an antihypertensive medication.
- •High-density lipoprotein cholesterol <40 mg/dL in males or <50 mg/dL in females.
- •Triglycerides ≥150 mg/dL or use of a cholesterol-lowering medication.
- •Waist circumference >40 inches (102 cm) for males or >35 inches (88 cm) for females (or body mass index >25 kg/m2).
排除标准
- •Pregnant and/or lactating women and women of child bearing potential who are not using acceptable means of contraception. Women of childbearing potential must be using adequate measures of contraception (as determined by the Principal Investigator) to avoid pregnancy and should be highly unlikely to conceive during the study period. Women of childbearing potential must have a negative pregnancy test at screen.
- •Diabetics taking any of the following anti-diabetic medications: insulin, metformin, thiazolidinediones, sulfonylureas, alpha-glucosidase inhibitors, meglitinides, or incretins.
- •Prior experience with fasting more than once per month (for 20 hours or more), on average during the last year.
- •Very low body mass index (BMI) (<18.5 kg/m2) or high BMI (>40 kg/m2).
- •Individuals who are nutritionally compromised, as assessed by the Principal Investigator.
- •Any immunodeficiency or prior solid organ transplantation or renal disease.
- •Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study.
- •Other conditions that in the opinion of the Principal Investigator may increase risk to the subject and/or compromise the quality of the clinical trial.
研究组 & 干预措施
water-only 24-hour fasting once per week for 6 weeks
Other
干预措施: water-only 24-hour fasting once per week for 6 weeks (Behavioral)
结局指标
主要结局
Difference in Mean Glucose Level Between Baseline and the End of the Sixth Week.
时间窗: 6 weeks
次要结局
- Difference in Weight Between Baseline and the End of the Sixth Week(6 weeks)
- Difference in Low-density Lipoprotein Cholesterol (LDL-C) Between Baseline and the End of the Sixth Week.(6 weeks)
- Difference in Human Growth Hormone (HGH) Between Baseline and the End of the Sixth Week.(6 weeks)
- Difference in Red Blood Cell Count Between Baseline and the End of the Sixth Week.(6 weeks)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Observational Study to Assess Glycosylated Hemoglobin Changes After 6 Months of Treatment With Pioglitazone.Diabetes MellitusNCT00449553Takeda326
已完成
不适用
DRIVE - Perioperative PeriodSurgical Procedure, UnspecifiedDiabetes MellitusNCT04033705Portsmouth Hospitals NHS Trust28
招募中
不适用
Impact of Intermittent Fasting on Biomarkers of Inflammation and Health-Related Quality of Life: A Feasibility Trial for Women With HR+/HER2- Early Breast CancerBreast CancerNCT06106477Medical College of Wisconsin20
Unknown
不适用
Cardiovascular Outcomes and HbA1c Among Patients With Type 2 Diabetes Newly Initiating GLP1RAs vs Basal InsulinDiabetes Mellitus, Type 2NCT04034524Brigham and Women's Hospital20,000
已完成
1 期
A Phase I Study to Determine the Effect of Food on Brivanib (BMS-582664)TumorsNCT00437437Bristol-Myers Squibb29