Mitochondrial Effects of C18:0 Supplementation in Type 2 Diabetics Versus Healthy Controls
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Changes in Mitochondrial Morphology
研究概览
简要总结
The purpose of this crossover study is to determine whether nutritional supplementation of C18:0 in humans has mitochondrial effects as shown in Drosophila and human cell culture. We will compare a study cohort of patients with diagnosed type 2 diabetes with non-diabetics. Participants will undergo a 2-day low-fat vegan diet and will then be supplemented with a bolus of C18:0. Changes in the mitochondrial morphology and function of white blood cells will be scored by immunofluorescence and FACS analysis.
详细描述
The purpose of this study is to determine whether nutritional supplementation of C18:0 in humans has mitochondrial effects as shown in Drosophila and human cell culture. We will compare a study cohort of patients with diagnosed type 2 diabetes with non-diabetics. Participants will undergo a 2-day low-fat vegan diet to reach baseline levels of C18:0 and will then be fed a milkshake supplemented with 24g of C18:0, which corresponds roughly to the C18:0 content of a fast-food meal. Blood samples will be taken at baseline and several hours after intake. We will look at changes in mitochondrial morphology of neutrophils by immunofluorescence, and score mitochondrial function via FACS analysis. Since this study is designed as a crossover study, participants will also receive a mock milk shake after another 2 days of low-fat vegan diet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •type 2 diabetes, either dietary treatment or oral medication
- •must be able to give consent
排除标准
- •insulin treated diabetes mellitus
- •severe diseases inducing wasting (e.g. cancer, liver cirrhosis, renal failure)
- •conditions of malnourishment
- •severe anemia
- •pregnancy
- •alcohol abuse
研究组 & 干预措施
Non-diabetics
Non-diabetic volunteers with HbA1c < 6.5%. Subjects will be treated with C18:0 supplementation or mock.
干预措施: mock (Dietary Supplement)
Type 2 Diabetics
Type 2 Diabetes according to common definitions, but we exclude insulin-treated Type 2 diabetics because nutritional intervention is more difficult/risky. Subjects will be treated with C18:0 supplementation or mock.
干预措施: mock (Dietary Supplement)
Type 2 Diabetics
Type 2 Diabetes according to common definitions, but we exclude insulin-treated Type 2 diabetics because nutritional intervention is more difficult/risky. Subjects will be treated with C18:0 supplementation or mock.
干预措施: C18:0 (Dietary Supplement)
Non-diabetics
Non-diabetic volunteers with HbA1c < 6.5%. Subjects will be treated with C18:0 supplementation or mock.
干预措施: C18:0 (Dietary Supplement)
结局指标
主要结局
Changes in Mitochondrial Morphology
时间窗: 2 days before supplementation, on the day of supplementation at 0, 3 and 6 h
Mitochondria of neutrophils are stained and scored via immunofluorescence microcsopy, either as "fragmented", "intermediate" or "fused". Statistical calculations will be performed on changes in fragmentation status after treatment.
Changes in Mitochondrial Function
时间窗: on the day of supplementation at 0, 3 and 6 h
Mitochondrial membrane potential and ROS production in neutrophils will be analyzed via FACS. Statistical calculations will be performed on changes in the respective levels after treatment.
次要结局
- plasma iron, transferrin, ferritin, ferroportin and hepcidin levels(2 days before supplementation, on the day of supplementation at 0, 3 and 6 h)
- plasma methylglyoxal levels(2 days before supplementation, on the day of supplementation at 0, 3 and 6 h)
- plasma fatty acid levels(2 days before supplementation, on the day of supplementation at 0, 3 and 6 h)
- insulin resistance(2 days before supplementation, on the day of supplementation at 0, 3 and 6 h)
- diabetic late complications(2 days before supplementation)
研究者
Daniel Pfaff
Principal Investigator
University Hospital Heidelberg