Precise Eating Time to Improve Glycemic Control and Cardiometabolic Health in Prediabetes and Diabetes: the GLYCOTIME Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Mean 24-hour glucose
研究概览
简要总结
The objective of this study is to investigate the impact of hypocaloric time-restricted eating (TRE) at different day times (early versus late TRE) on glucose metabolism and other cardiometabolic parameters in individuals with overweight and with normal, or impaired glucose metabolism (prediabetes and type 2 diabetes). In addition, the study aims to elucidate the molecular mechanisms underlying these effects.
详细描述
This dietary intervention study will follow a crossover design. During the intervention phases, participants will restrict their dietary intake to a defined eating window of 8 hours - predominantly in the morning (early TRE) or predominantly in the afternoon (late TRE) - in conjunction with a moderate caloric restriction for five weeks. A 10-12-week washout phase will separate the intervention periods.
Overweight and obese individuals with healthy glucose metabolism, prediabetes, or non-insulin-treated type 2 diabetes will be recruited for the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Overweight or obesity (BMI 25-40 kg/m²)
- •Healthy glucose metabolism (fasting glucose <100 mg/dl and glucose after 2 hours OGTT <140 mg/dl)
- •OR impaired glucose metabolism (fasting glucose 100-125 mg/dl and/or glucose after 2 hours OGTT 140-199 mg/dl and/or HbA1c 5.7-6.4%)
- •OR type 2 diabetes (according to existing medical diagnosis or fasting glucose >126 mg/dl and/or glucose after 2 hours OGTT >200 mg/dl and/or HbA1c ≥6.5%)
- •Daily eating window ≥12 hours
排除标准
- •Weight changes > 5% within past 3 months
- •Shift work
- •Traveling across more than one time zone within one month prior to the study
- •Pregnancy and breastfeeding
- •Eating disorders, food intolerance/allergy to ingredients in the diet product, vegan diet, practicing time-restricted eating
- •Severe chronic illnesses or other conditions that are incompatible with the planned intervention and examination program (e.g. type 1 diabetes, recent cardiovascular event, malabsorption, cancer in the last two years, etc.)
- •Treatment with insulin, sulfonylureas, and GLP-1 receptor agonists, steroid use (oral, cutaneous, or parenteral), regular intake of melatonin, anticoagulation treatment that cannot be paused
- •Extreme early and extreme late chronotypes
结局指标
主要结局
Mean 24-hour glucose
时间窗: 5 weeks
Mean 24-hour glucose assessed by continuous glucose monitoring (CGM)
次要结局
- Waist and hip circumference(5 weeks)
- Body composition(5 weeks)
- Glycemic variability(5 weeks)
- Glucose levels(5 weeks)
- Insulin levels(5 weeks)
- Glucagon levels(5 weeks)
- Insulin resistance(5 weeks)
- Insulin secretion(5 weeks)
- Body weight(5 weeks)
- Body Mass Index (BMI)(5 weeks)
- Fasting cholesterol(5 weeks)
- Fasting triglycerides(5 weeks)
- Blood pressure(5 weeks)
- Resting energy expenditure(5 weeks)
- Gene expresssion in adipose tissue(5 weeks)
- Inflammatory markers in blood and adipose tissue(5 weeks)
- Subjective satiety and hunger sensation(5 weeks)
- Concentration of satiety and hunger regulating hormones(5 weeks)
- Species and strain-level microbiome changes(5 weeks)
- Levels of microbiome-derived metabolites(5 weeks)
- Sleep quality(5 weeks)
- Sleep and wake timing(5 weeks)
- Internal circadian phase(Screening visit (week 0))
- Glucagon-like peptide-1 levels(5 weeks)
- Gastric inhibitory polypeptide(5 weeks)
- Gene expresssion in peripheral mononuclear blood cells (PBMCs)(5 weeks)
- Malondialdehyde(5 weeks)
- 3-nitrotyrosine(5 weeks)
- Protein carbonyls(5 weeks)
- 36-item Short Form Health Survey (SF-36) to measure health-related quality-of-life(5 weeks)
- Satisfaction with the intervention(5 weeks)
- Decision behavior(5 weeks)
研究者
Olga Ramich (formerly Pivovarova)
Head of Department Molecular Metabolism and Precision Nutrition
German Institute of Human Nutrition