Residual Insulin Secretion in Patients With Type 1 Diabetes Under a Low Carbohydrate Diet or a Ketogenic Diet
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Peptide C evolution
研究概览
简要总结
Low Carbohydrate Diet (LCD) (< 130 g of carbohydrate per day) and ketogenic diet (< 50 g of carbohydrate per day) are popular among patients with type 1 diabetes (T1D). In most cases, LCD allow a better glycemic control and a important decrease of insulin requirements that cannot, however, be the sole result of low carbohydrate intake. However, due to the increase production of ketone bodies and the decrease of the insulin/glucagon rate, this diet is not without risk in T1D patients and some of them develop ketoacidosis.
Type 1 diabetes is a autoimmune disease defined by the destruction of the pancreatic beta cells by the effector T cells, in condition of low regulatory T cells (Tregs). Indeed, some nutrients could regulate the plasticity and the function of Tregs, and be involved in the control of some autoimmune diseases in animals models thanks to a direct effect on immune cells of the digestive tract or an indirect effect by microbiota modulation.
The study hypothesises that LCD may be able to restore residual insulin secretion in some patients by modulating immunity. The metabolic mechanisms leading to the effects described in patients with T1D patients under LCD have not been studied : in particular, there is no data on the evolution of the residual insulin secretion and no immunological parameter has been studied on these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old or older
- •type 1 diabetes for less than 20 years
- •willing to start a low carbohydrate diet of less than 75 g per day
- •under continuous glucose monitoring
- •having been informed about the study and having given their written and informed consent
排除标准
- •already on a low carbohydrate diet of less than 100 g per day
- •history of ketoacidosis within the last 5 years, except during diabetes diagnosis
- •autoimmune disease, except thyroiditis
- •immunosuppressive treatment
- •hepatitis B virus, hepatitis C virus or human immunodeficiency virus infection
- •ongoing cancer or history of cancer within the past 5 years, except in situ cervical cancer or basal cell cancer with early treatment
- •participation to another interventional study within the past 3 months
- •pregnancy or breast feeding
- •no affiliation to a social security scheme
- •patients subject to legal protection measures
- •unability to give consent for the study
研究组 & 干预措施
LCD
干预措施: Low carbohydrate diet (Behavioral)
结局指标
主要结局
Peptide C evolution
时间窗: Day 0 and day 90
Measure of the area under the curve of the peptide C dosage
次要结局
- Insulin-dose adjusted A1c (IDAA1C) index calculation(Day 0 and day 90)
- HbA1C measure(Day 0 and day 90)
- Weight measure(Day 0 and day 90)
- Daily dose of insulin(Every day from day 0 to day 90)
- Lean mass percentage measure(Day 0 and day 90)
- Fat mass percentage measure(Day 0 and day 90)
- Circulating rate of Tregs(Day 0 and day 90)
- Circulating rate of cytokines(Day 0 and day 90)