Effect of Inulin Supplementation on Glycaemic Control and Immunological Parameters in Type 1 Diabetes (2024)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Time in range
研究概览
简要总结
The goal is to establish the effect of oral inulin supplementation on continuous glucose monitoring (CGM) metrics and immunological parameters in adults with type 1 diabetes. The investigators will perform a double-blind, randomized, placebo-controlled trial in 2x38 participants to measure effects on CGM metrics, gut microbiome composition, residual beta cell and immunological parameters.
详细描述
The investigators perform a double-blind, randomized, placebo-controlled trial in 2x38 adults with type 1 diabetes. The participants will be given inulin or placebo once daily in powder, which can be dissolved in water and ingested orally, for 90 days. The main study endpoint is the difference in time in range between the groups between baseline and end-of-study. Secondary endpoints include changes in glycaemic variability, time in tight glycaemic range and hypoglycaemic episodes, gut microbiome composition, changes in residual beta cell function, changes in immunological parameters and validated questionnaires (Quality of Life and gastro-intestinal complaints).
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
The unblinded researcher will provide the study intervention to the blinded investigator in a coded fashion. Both the investigator and the participant are blinded. In case of emergency, an unblinding protocol is activated.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of type 1 diabetes, as made by their primary clinician
- •A time in range of <80% in the last four weeks before screening
排除标准
- •Use of any fibre supplementation (within the last month before screening or ongoing)
- •Use of antibiotics in the lasts three months before screening or during study period
- •Active infection during the study visit
- •Inability or unwillingness to donate feces or urine.
- •Illicit drug use (e.g. MDMA/amphetamine/cocaine/heroin/GHB) in the past three months or use during the study period.
- •Inability or unwillingness to provide informed consent.
- •Absence of a large bowel (ie colostomy)
- •Active inflammatory bowel disease
研究组 & 干预措施
Placebo
Placebo: Maltodextrin
干预措施: Placebo (Dietary Supplement)
Inulin
prebiotic fermentable fiber inulin
干预措施: Inulin (prebiotic, fermentable fiber) (Dietary Supplement)
结局指标
主要结局
Time in range
时间窗: 90 days
Difference in time in range between the groups between baseline and end-of-study
次要结局
- Residual beta cell function(90 days)
- CRP(90 days)
- Leukocyte (differentation)(90 days)
- Immunological parameters(90 days)
- Gastrointestinal Symptom Rating Scale (GSRS)(90 days)
- Diabetes autoantibodies anti-GAD, anti-IA2, anti-ZnT8(90 days)
- HbA1c(90 days)
- Gut inflammation(90 days)
- Quality of life questionnaire(90 days)
- Continuous glucose monitoring(90 days)
- Gut microbiome composition(90 days)
- Dietary intake(90 days)
研究者
Max Nieuwdorp
Principial investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)