The Fasting II Study
2017年2月10日 更新者:Intermountain Health Care, Inc.
Preparatory Study to Determine Which Risk Markers May be Reduced by Fasting and Should be Evaluated in a Future Randomized Trial
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).
研究概览
研究类型
介入性
注册 (实际的)
12
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Utah
-
Murray、Utah、美国、84107
- Intermountain Medical Center
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Salt Lake City、Utah、美国、84107
- Intermountain Medical Center
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
30年 至 69年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
其他:water-only 24-hour fasting once per week for 6 weeks
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Difference in Mean Glucose Level Between Baseline and the End of the Sixth Week.
大体时间:6 weeks
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6 weeks
|
次要结果测量
结果测量 |
大体时间 |
---|---|
Difference in Weight Between Baseline and the End of the Sixth Week
大体时间:6 weeks
|
6 weeks
|
Difference in Low-density Lipoprotein Cholesterol (LDL-C) Between Baseline and the End of the Sixth Week.
大体时间:6 weeks
|
6 weeks
|
Difference in Human Growth Hormone (HGH) Between Baseline and the End of the Sixth Week.
大体时间:6 weeks
|
6 weeks
|
Difference in Red Blood Cell Count Between Baseline and the End of the Sixth Week.
大体时间:6 weeks
|
6 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Benjamin D Horne, PhD, MPH、Intermountain Health Care, Inc.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年2月1日
初级完成 (实际的)
2013年6月1日
研究完成 (实际的)
2013年6月1日
研究注册日期
首次提交
2013年2月12日
首先提交符合 QC 标准的
2013年2月13日
首次发布 (估计)
2013年2月15日
研究记录更新
最后更新发布 (实际的)
2017年3月20日
上次提交的符合 QC 标准的更新
2017年2月10日
最后验证
2013年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.