Meal Timing-based Strategies to Improve Glucose Metabolism in Prediabetes and Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Mean 24-hour glucose
研究概览
简要总结
The overall aim is to identify the dietary pattern for prevention and treatment of type 2 diabetes. The specific aim of this pilot project is to compare effects of two diets with different diurnal distribution of carbohydrates and protein on the glucose metabolism in subjects with prediabetes and type 2 diabetes and its effects on inflammatory status.
详细描述
Overweight individual with prediabetes and non-insulin treated type 2 diabetes will be recruited for the study. The trial will have a cross-over design and compare metabolic effects of two isocaloric 4-week interventions with opposite timely distribution of macronutrient intake - a high-protein (HP) breakfast and a high-carb (HC) dinner (HP/HC intervention) vs. a HC breakfast and a HP dinner (HC/HP intervention) - divided by a 4-week wash-out phase. A HP low-carb meal (breakfast or dinner) will contain 35%E protein, 35%E carbs, and 30%E fat, and a HC meal (breakfast or dinner) will contain 10E%protein, 60%E carbs, and 30%E fat.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prediabetes (fasting blood sugar 100-125 mg/dl)
- •Diabetes type 2 (fasting blood sugar >126 mg/dl)
- •Overweight and obesity (BMI 25-50 kg/m2)
排除标准
- •Other diabetes types
- •Insulin treatment
- •Shift work
- •Weight changes >5% within past 3 months
- •Systemic glucocorticoid therapy
- •Systemic infections
- •Severe anemia
- •High blood pressure (>180/110 mmHg)
- •Endocrinologic, liver and heart disorders
- •Immune diseases
- •Thyroid dysfunction
- •Heart attack or stroke
- •Cancer in the last 2 years
- •Eating disorders, food intolerance/allergy, addiction disorders, digestive disorders intestinal, liver, cardiovascular diseases
- •Hereditary or acquired coagulation disorders
- •Non-interruptible intake of blood thinners (anticoagulants)
- •Specific diets, intermittent fasting
- •Pregnancy or breastfeeding
- •Severe internal or psychiatric disorders or other conditions and drugs therapy that might influence the outcome of the study
研究组 & 干预措施
HC/HP - HP/HC
Isocaloric 4-week HC/HP intervention followed by a 4-week HP/HC intervention.
干预措施: Diet with specific macronutrient composition. (Other)
HP/HC - HC/HP
Isocaloric 4-week HP/HC intervention followed by a 4-week HC/HP intervention.
干预措施: Diet with specific macronutrient composition. (Other)
结局指标
主要结局
Mean 24-hour glucose
时间窗: 4 weeks
Mean 24-hour glucose assessed by continuous glucose monitoring (CGM)
次要结局
- Measurement of body weight(4 weeks)
- Renal values (creatinine, urea, uric acid)(4 weeks)
- Intra- und inter-day glycemic variability(4 weeks)
- Inflammatory markers and T cell populations analyses(4 weeks)
- Waist and hip circumference / waist to hip ratio(4 weeks)
- Systolic and diastolic blood pressure(4 weeks)
- Energy expenditure and substrate oxidation rates(4 weeks)
- Measurement of height(4 weeks)
- Body fat and lean mass(4 weeks)
- Gene expression in peripheral blood mononuclear cells (PBMC)(4 weeks)
- Glucose levels in meal tolerance test (MTT)(4 weeks)
- Metabolic hormones (insulin, C-peptide, glucagon, glucagon-like peptite 1(GLP-1), gastric inhibitory polypeptide (GIP), peptide YY (PYY), ghrelin, adiponectin, leptin)(4 weeks)
- Hepatic values (gamma-glutamyl transferase (GGT), aspartate aminotransferase (AST), alanine aminotransferase (ALT))(4 weeks)
- Physical activity(4 weeks)
- Adipose tissue transcriptome(4 weeks)
- Satiety and hunger scores(4 weeks)
- Sleep/wake timing and sleep quality(4 weeks)
- Gut microbiota and microbiome-derived metabolites(4 weeks)
- Determination of decision behavior(4 weeks)
研究者
Olga Ramich (formerly Pivovarova)
Head of Research Group Molecular Nutritional Medicine
German Institute of Human Nutrition