Fasting-Associated Immune-metabolic Remission of Diabetes Type 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Concentration of fasting blood glucose < 126 mg/deciliter
研究概览
简要总结
People with a body mass index above 28 kg/m² and an onset of type 2 diabetes within the last 4 years had a remission (HbA1c <6.5% without medication) of diabetes in over 80% upon weight loss of 15 kg. Longer duration of diabetes reduced the chance of remission. The investigators will test whether there is a difference in remission upon weight loss of 15 kg using formula low calorie diets between subjects with a diabetes duration of <4 years vs. >8 years and oral treatment as primary end points. The immune metabolic programming of circulating monocytes will be investigated in detail regarding trained innate immunity and the endocrine responses will be determined using meal challenge tests.
详细描述
A remission of type 2 diabetes can be achieved in over 80% of people with a diagnosis within the last 4 years and overweight or obesity by weight loss of 15 kg. The mechanisms involve an improvement of insulin sensitivity and thereby insulin requirements and a regain of the function of insulin secreting beta cells. Longer duration of type 2 diabetes appears to impair the capacity of beta cell to regenerate. At present it is not possibe to predict success of the weight loss at an early time point. The investigators therefore aim to identify early markers of responders. It is unclear how the weight loss induces the remission in responders. Immune cells are known to contribute to insulin resistance by regulating adipose tissue function and hepatic and skeletal muscle metabolism by releasing cytokines. The inborn immune system is known to adapt to external stimuli by the process of trained immunity and is thought to contribute to insulin resistance and the dysfunction of beta-cells. The investigation will analyze the programming state of innate immune cells in detail in the course of diabetes remission. In addition, islet hormone responses to challenge tests will be performed to assess their function in detail.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes diagnosed less than 4 or over 8 years, before study,
- •BMI > 28 kg/m²,
- •willingness to follow weight loss diet,
排除标准
- •consuming disease,
- •intolerance for very low calorie formula diet,
- •known severe hepatic disease or liver cirrhosis,
- •type 1 diabetes,
- •severe disease of kidney or heart,
- •advanced diabetic retinopathy,
- •intake of glucocorticoids,
- •drug or alcohol abuse,
- •weight loss of >5 kg in the last 3 month,
- •eating disorder
研究组 & 干预措施
type 2 diabetes - less than 4 years duration
Patients with a duration of less than 4 years since diagnosis of type 2 diabetes, BMI > 28 kg/m², non-insulin treated who agree to loose 15 kg body weight by eating a very low calorie formula diet of 800 kcal/day for men and 600 kcal/day for women. The duration of the diet is until the weight loss is achieved.
干预措施: weight loss by very low energy diet intake which may differ in protein or carbohydrate content (Behavioral)
type 2 diabetes - more than 8 years
Patients with a duration of more than 8 years since diagnosis of type 2 diabetes, BMI > 28 kg/m², non-insulin treated who agree to loose 15 kg body weight by eating a very low calorie formula diet of 800 kcal/day for men and 600 kcal/day for women. The duration of the diet is until the weight loss is achieved.
干预措施: weight loss by very low energy diet intake which may differ in protein or carbohydrate content (Behavioral)
结局指标
主要结局
Concentration of fasting blood glucose < 126 mg/deciliter
时间窗: 3 month
Remission of type 2 diabetes defined by a concentration of a fasting blood glucose \< 126 mg/deciliter without diabetes medication
次要结局
- Immune-metabolic profile and programing of innate immunity(before, after 7 days and after 3 month)
- Composition of the microbiome(before, after 7 days and after 3 month)
研究者
Prof. Dr. med. Andreas F. H. Pfeiffer
Senior Professor
Charite University, Berlin, Germany