Effect of Low-Calorie Diets on Remission of Type 2 Diabetes: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Percent of adherence to the intervention
研究概览
简要总结
The prevalence of type 2 diabetes mellitus (T2DM) has been increasing rapidly in China. China currently has ~130 million diabetes cases, and over 90% are T2DM. T2DM is a leading cause of morbidity and mortality, posing substantial clinical and public health challenges. Reversing T2DM with a significant amount of weight loss via consuming a low-calorie diet is possible, but no studies have been conducted to determine whether low-calorie diets will help achieve significant weight loss and diabetes remission among Chinese patients with T2DM. The investigators design a pilot study to assess the feasibility of a low-calorie diet intervention program on weight loss and diabetes remission in a Chinese population with T2DM.
详细描述
Consistent evidence has shown that overweight and obesity are the leading cause of T2DM, which exacerbates the development of insulin resistance and disease progression. For overweight and obese patients with T2DM, there is a strong consensus that sustained and moderate weight loss can effectively improve glycemic control and blood pressure as well as reduce the need for glucose-lowering medications and improve quality of life.
Short-term dietary interventions using structured low-calorie diets (800-1,000 kcal/day) have shown to be an effective approach for losing weight and promoting sustained diabetes remission in T2DM patients who are overweight or obese. The United Kingdom DiRECT research team designed a structured, intensive intervention program of 12-20 weeks to achieve substantial weight loss and T2DM remission through energy restriction. Researchers recorded ≥15 kg of weight loss in 24% of the participants who underwent a low-calorie formula diet intervention (total diet replacement with 825-853 kcal/day formula low-energy diet meal replacement products). Among these participants, the diabetes remission rate reached 90%.
This non-randomized dietary intervention study comprises 2 study arms: a formula diet (815-835 kcal/day) and a food-based diet (815-835 kcal/day). Participants will be on either of the two low-calorie diets for 12 weeks to achieve at least 12 kg of weight loss (intensive weight loss phase). Participants may extend the weight loss phase if desired. After 12 weeks, participants in the formula diet group are allowed to consume actual meals gradually, and participants in both groups will increase their energy consumption gradually over the next 12 weeks (weight loss achievement and maintenance phase). Physical activity is recommended during the second phase for maintaining weight loss. This study is designed to assess feasibility of the low-calorie diet intervention, in preparation for a full-scale randomized control study. This pilot study also plans to explore potential mechanisms of the intervention for weight loss and diabetes remission.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physician-diagnosed T2DM
- •Most recent HbA1c level: 6.5%-12.0%
- •Body mass index: 24-45 kg/m2
- •Informed consent signed by participants in this study in accordance with requirements of local regulations and the Ethical Review Committee
- •No plan to leave Shanghai in 2 years
排除标准
- •Type 1 diabetes
- •Current use of insulin and glucagon-like peptide-1 receptor agonists
- •Major cardiovascular events (e.g., myocardial infarction, stroke, and heart failure) within the previous 6 months
- •Weight loss >5 kg within the past 6 months
- •Diagnosed eating disorders or any dieting behaviors
- •Chronic kidney disease stage 3b or higher (estimated glomerular filtration rate <30 milliliter /min/1.73m2)
- •Previously diagnosed psychiatric disorders, e.g., schizophrenia, post-traumatic stress disorder, obsessive-compulsive disorder, uncontrolled depression, uncontrolled epilepsy
- •Severe arthritis and gout
- •Gallstone disease or known asymptomatic gallstones
- •Participation in another clinical research trial
- •Being pregnant or have a positive pregnancy test result at screening, or have given birth within the past 90 days, or who are breastfeeding.
- •Any known cancers
- •Learning difficulties
- •Alcoholism
- •Pancreatitis
结局指标
主要结局
Percent of adherence to the intervention
时间窗: Baseline to 24 weeks
Percent of adherence is calculated at the end of the intervention by dividing the number of participants who remain in and adhere to the intervention by the total number of participants who participate in the intervention.
Percent of participants achieving significant weight loss and diabetes remission
时间窗: Baseline to 24 weeks
Proportion of participants achieving significant weight loss (≥12kg) and diabetes remission, which is defined as having a glycated hemoglobin (HbA1c) level less than 6.5% while receiving no pharmacological therapy for diabetes for at least 3 months, will be estimated at 24 weeks.
次要结局
- Aggregated safety assessment(Baseline to 24 weeks)
- Level of postprandial glucose(Baseline to 24 weeks)
- Level of HbA1c(Baseline to 24 weeks)
- Health-related quality of life(Baseline to 24 weeks)
- Sleep quality(Baseline to 24 weeks)
- Insulin sensitivity(Baseline to 24 weeks)
- Beta cell function(Baseline to 24 weeks)
- Body fat composition and fat distribution(Baseline to 24 weeks)
- Level of fasting glucose(Baseline to 24 weeks)
- Glucose homeostasis(Baseline to 24 weeks)
- Gut microbiota(Baseline to 24 weeks)
- Traditional Chinese Medicine(TCM) tongue diagnosis estimated by tongue-face diagnosis instrument(Baseline to 24 weeks)
- TCM facial diagnosis estimated by tongue-face diagnosis instrument(Baseline to 24 weeks)
- Diet(Baseline to 24 weeks)
- Binge eating behaviors(Baseline to 24 weeks)
- Diet and eating behaviors(Baseline to 24 weeks)
- Psychological status-Anxiety(Baseline to 24 weeks)
- Psychological status-Depression(Baseline to 24 weeks)
- Metabolomic profiling performed by liquid chromatography mass spectrometry(Baseline to 24 weeks)
研究者
Feng Tao
Director
Shanghai Municipal Hospital of Traditional Chinese Medicine