The Optimal Diet for Optimising Health in Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Glucose control
研究概览
简要总结
Type 1 diabetes is an autoimmune condition where circulating immune cells destroy the beta-cells in the pancreas that make insulin, resulting in a degree of insulin deficiency, whereby blood glucose levels rise and diabetes develops. When there is severe insulin deficiency, life-threatening ketoacidosis can develop. Treatment is lifelong insulin replacement therapy; dietary intervention is a also cornerstone of glucose management.
The Optimise Diet is a multi-pronged diet based on "best health" principles: to minimise blood glucose rises after eating, reduce the immune cells involved in destruction of the insulin-secreting beta-cells, and improve the gut microbiome and systemic inflammation. In this study, its effects will be compared to the Standard Diabetes Diet that is currently recommended in Australia and internationally.
详细描述
The rationale for this study is to determine whether a diet based on recent scientific advances in diet-induced inflammation, will improve diabetes care in people with type 1 diabetes.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •type 1 diabetes
排除标准
- •Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study.
研究组 & 干预措施
Novel type 1 diet
Experimental diet to be examined: altered macronutrient composition: lower carbohydrate, Mediterranean-style, prebiotic fibre focus.
干预措施: Novel diet (Other)
Standard therapy
Standard dietary therapy, as promulgated by Australian standards
干预措施: Standard diet (Other)
结局指标
主要结局
Glucose control
时间窗: 3 months
HbA1c
次要结局
- Gut microbiome(3 months)
- postprandial glucose excursion(3 months)
- Inflammation(3 months)
- C-peptide(3 months)
- Follow-up of glycemic control and insulin secretion(12 and 24 months)
研究者
Professor Katherine Samaras
Professor
Garvan Institute of Medical Research