Time Restricted-eating and Metabolic Health in Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Differences in baseline-adjusted Insulin-Secretion-Sensitivity Index-2 (ISSI-2) between the study groups.
研究概览
简要总结
Time-restricted eating - where no food is consumed over a period of time - has been shown to promote weight loss and improve cardio-metabolic function. In individuals with type 2 diabetes, it is also been shown to improve glucose control. The investigators propose a randomized controlled trial to determine whether time-restricted eating is an effective therapeutic strategy that can preserve pancreatic beta-cell function and improve glycemic control early in participants with type 2 diabetes.
详细描述
In this study, eligible patients with type 2 diabetes will be randomized to either time-restricted eating or standard lifestyle. The hypothesis under study is whether time-restricted eating can improve pancreatic beta-cell function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with previously diagnosed BMI ≥ 25 kg/m2 and type 2 diabetes within preceding 10 years.
- •Age 18 - 75 years inclusive
- •Stable weight over past 12 weeks (less than 5% change in body weight) (self-reported)
- •Diabetes treatment consisting of lifestyle only or metformin, dipeptidyl peptidase-4 (DPP-4) inhibitor, and sodium-glucose co-transporter 2 (SGLT2) inhibitors either as monotherapy or in combination.
- •Ability to read and understand English
排除标准
- •Current diabetes treatment with insulin, glucagon-like peptide-1 receptor agonists, and/or sulfonylureas.
- •Use of any other pharmacological treatment for weight-loss
- •Previous surgical treatment for weight loss such as gastric bypass or gastric band
- •Any history of eating disorder
- •Currently pregnant or lactating
- •Renal dysfunction as evidenced by estimated glomerular filtration rate < 25 ml/min by CKD-EPI Creatinine Equation
- •New York Heart Association class II-IV heart failure
- •Hepatic disease considered to be clinically significant (includes jaundice, chronic hepatitis, or previous liver transplant) or transaminases >2.5X the upper limit of normal
- •Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer)
- •Any other factor likely to limit adherence to the study, in the opinion of the investigators
- •Concurrent participation in another research study relevant to diabetes and metabolic health
研究组 & 干预措施
Time-restricted eating
Time-restricted eating protocol consisting of time-restricted eating with 18 hours of fasting and 6 hour window of eating (between 2 to 8 PM) every day.
干预措施: Time-restricted eating (Behavioral)
Standard lifestyle
Standard lifestyle recommendation as per Diabetes Canada Guidelines.
干预措施: Standard lifestyle (Behavioral)
结局指标
主要结局
Differences in baseline-adjusted Insulin-Secretion-Sensitivity Index-2 (ISSI-2) between the study groups.
时间窗: 52-weeks
Baseline-adjusted beta-cell function at 52 weeks, measured by Insulin Secretion-Sensitivity Index-2 (ISSI-2).
次要结局
- Differences in baseline-adjusted insulin resistance between the study groups(52-weeks)
- Differences in time in glucose target range between each study group(52-weeks)