Intermittent Fasting for the Treatment of Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Adherence to Diet Protocols
研究概览
简要总结
To test whether a lifestyle program featuring one of two forms of intermittent fasting (IER or TRE) can feasibly and effectively improve glycemia in patients with type 2 diabetes, and potentially induce diabetes remission.
详细描述
Intermittent energy restriction (IER) and time-restricted eating (TRE) are two distinct forms of intermittent fasting which have yet to be compared for the treatment of type 2 diabetes. Investigators will test whether a comprehensive, intensive lifestyle program featuring each of these intermittent fasting approaches is feasible and effective for improving glycemic control in patients diagnosed with type 2 diabetes within the past 10 years. Both interventions will be delivered over one year in three phases: (1) a 12-week weight loss program featuring weekly group meetings, (2) a 12-week weight maintenance program featuring biweekly group meetings, and (3) a 6-month low-contact follow up period featuring monthly check-ins.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 双盲 (研究者、结局评估者)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Diagnosed with type 2 diabetes in the past 10 years.
- Age 21-65 years
- BMI of 25 - 45 kg/m2
- HbA1c of 6.7-9.5%, or those with A1c of <6.7% on glucose-lowering medications
- Ability to participate in a graduated physical activity program
- Clearance from study physician.
排除标准
- Inability to attend health education meetings.
- Weight change of >=5% in the previous 3 months.
- Addition of new antihyperglycemic or weight-reducing medication in the previous 2 months.
- Serious medical risk such as ongoing treatment for cancer, uncontrolled hypertension, recent cardiac event, or other medical condition presenting acute risk of participation in a lifestyle change program.
- Untreated depression or anxiety, or increase in associated medications in the previous 3 months.
- Current participation in another lifestyle change intervention, such as a tobacco cessation program or physical activity program.
- Pregnancy or lactation within the previous six months
- Weight of >450 lbs
- Currently taking medications that may result in hypoglycemia during fasting and unwilling to stop prior to the study
研究组 & 干预措施
Intermittent energy restriction (IER)
Intermittent fasting using a very-low energy diet (VLED; 550-800 kcal/d) 2-3 days per week
干预措施: Intermittent energy restriction (IER) (Behavioral)
Time-restricted eating (TRE)
Intermittent fasting using an 8-hour eating period.
干预措施: Time Restricted Eating (TRE) (Behavioral)
结局指标
主要结局
Adherence to Diet Protocols
时间窗: Weekly from baseline to 52 weeks
Acceptability of IER and TRE over one year as assessed by compliance to program recommendations (% of weeks adhered)
Retention
时间窗: 52 weeks
Feasibility of IER and TRE over one year assessed by participant retention (% of participants completed).
Adherence to diet protocols
时间窗: Weekly from baseline to 52 weeks
Acceptability of IER and TRE over one year as assessed by compliance to program recommendations (# weeks adhered / # study weeks).
次要结局
- Postprandial Glucose(Change from baseline to 24 weeks)
- Oral Glucose Tolerance Test(Change from baseline to 24 weeks)
- HbA1c(Change from baseline to 24 weeks)
- Insulin sensitivity(Change from baseline to 24 weeks)
- Isulin resistance(Change from baseline to 24 weeks)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT05860413
- 其他研究编号
- STUDY00149127
日期
- 首次提交
- (3年前)
- 首次发布
- (3年前)
- 主要完成日期
- (去年)
- 研究完成日期
- (去年)
- 最近核实
- (5个月前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 是
- 是否有结果
- 是