Precise Eating Time to Improve Glycemic Control and Cardiometabolic Health in Prediabetes and Diabetes

Официальное название

Precise Eating Time to Improve Glycemic Control and Cardiometabolic Health in Prediabetes and Diabetes: the GLYCOTIME Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Early Time-Restricted Eating
  Participants will restrict their eating window (8 hours eating and 16 hours fasting per day) and caloric intake moderately. During the early TRE intervention, participants will primarily consume their meals in the morning. The precise eating window will be defined based on the individual chronotype of the participants. Additionally, participants will be required to reduce their daily caloric consumption by 25%. They will replace one daily meal with a calorie-reduced product to facilitate calori
• Поведенческое Late Time-Restricted Eating
  Participants will restrict their eating window (8 hours eating and 16 hours fasting per day) and caloric intake moderately. During the late TRE intervention, participants will primarily consume their meals in the evening. The precise eating window will be defined based on the individual chronotype of the participants. Additionally, participants will be required to reduce their daily caloric consumption by 25%. They will replace one daily meal with a calorie-reduced product to facilitate caloric

Первичные конечные точки

• Mean 24-hour glucose [Срок оценки: 5 weeks]

Вторичные конечные точки (12)

• Glycemic variability [Срок оценки: 5 weeks]
• Glucose levels [Срок оценки: 5 weeks]
• Insulin levels [Срок оценки: 5 weeks]
• Glucagon levels [Срок оценки: 5 weeks]
• Insulin resistance [Срок оценки: 5 weeks]
• Insulin secretion [Срок оценки: 5 weeks]
• Body weight [Срок оценки: 5 weeks]
• Body Mass Index (BMI) [Срок оценки: 5 weeks]
• Waist and hip circumference [Срок оценки: 5 weeks]
• Body composition [Срок оценки: 5 weeks]
• Fasting cholesterol [Срок оценки: 5 weeks]
• Fasting triglycerides [Срок оценки: 5 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Германия · 1 центр

• German Institute of Human Nutrition Potsdam-Rehbruecke — Nuthetal

Идентификаторы

NCT: NCT07171281 · 85/2023 · TEMP643937-BO-ff

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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