Biweekly Interval Intermittent Fasting for Type 2 Diabetes, a Safety Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Number of hypoglycemic events
研究概览
简要总结
The purpose of this study is to establish safety of biweekly intermittent fasting in the setting of type 2 diabetes mellitus or prediabetes under treatment with non-hypoglycemic agents (e.g. metformin).
详细描述
This study is proposed as a prospective interventional cohort safety study for biweekly intermittent fasting.
In the effort to improve compliance of lifetime dietary change, the version of 5:2 intermittent fasting to be applied in this study will be somewhat less intensive than implemented then what has been proposed in some recent, similar studies.
On fasting days, instead of limiting the subject to a specific calorie count, the subject will be instead instructed to skip either the first or last meal of the day in order to complete a 12 to 16 hour fast, during which time they are allowed drink water or any non-caloric beverage of their choice, but not consume any calories.
Furthermore, the patient will be instructed for their remaining 2 meals to consume no more than they would on a normal, non-fasting day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •**Subjects must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study**
- •Inclusion Criteria:
- •Male and female Active Duty members and DoD beneficiaries ages 18-69
- •Diagnosed with Type 2 Diabetes or pre-diabetic
- •Prescribed/taking Metformin 500mg to 2000mg daily
排除标准
- •History of recurrent hypoglycemic events on present medication regimen
- •Drugs/medication with known increase in hypoglycemic events [Include basal insulin, rapid acting insulin, sulfonylureas, etc.). Metformin is not known to cause hypoglycemia.
- •Medication-induced or secondary diabetes
- •Known abnormal hematocrit
结局指标
主要结局
Number of hypoglycemic events
时间窗: Number will vary depending on the number of hypoglycaemic events per each subject and will be recorded throughout study until completion at 12 weeks
This study's intent is to investigate the safety of this intervention for use in a broader scope. It is imperative that risks are known for each subpopulation of diabetics. To this point, our literature review indicates that hypoglycemic events did occur at higher rates in fasting populations taking hypoglycemic medications. We intend to look at rates of hypoglycemia on those not on hypoglycemic medications to assess if this trend continues.
次要结局
未报告次要终点
研究者
gino gaddini
Principal Investigator
Mike O'Callaghan Military Hospital