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富含蛋白质的膳食可控制血糖 (PROTIME)

2026年9月26日 更新者：Olga Ramich (formerly Pivovarova)、German Institute of Human Nutrition

基于进餐时间的策略可改善糖尿病前期和 2 型糖尿病患者的葡萄糖代谢

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.

研究概览

地位

主动，不招人

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

30

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 德国
    • Potsdam-Rehbrücke
      • Potsdam、Potsdam-Rehbrücke、德国、14558
        • Olga Ramich

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：随机化
  • 介入模型：交叉作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：HP/HC - HC/HP

Isocaloric 4-week HP/HC intervention followed by a 4-week HC/HP intervention.
其他：Diet with specific macronutrient composition.

The intervention is about an isocaloric diet that differs in terms of distribution of carbohydrates and protein throughout the day. The interventions include a HP-breakfast and a HC-dinner vs. a HC-breakfast and a HP-dinner. 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 10%E protein, 60%E carbs, and 30%E fat.
实验性的：HC/HP - HP/HC

Isocaloric 4-week HC/HP intervention followed by a 4-week HP/HC intervention.
其他：Diet with specific macronutrient composition.

The intervention is about an isocaloric diet that differs in terms of distribution of carbohydrates and protein throughout the day. The interventions include a HP-breakfast and a HC-dinner vs. a HC-breakfast and a HP-dinner. 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 10%E protein, 60%E carbs, and 30%E fat.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Mean 24-hour glucose
大体时间：4 weeks

Mean 24-hour glucose assessed by continuous glucose monitoring (CGM)
4 weeks

次要结果测量

结果测量
措施说明
大体时间
Measurement of height
大体时间：4 weeks

Height measured by stadiometer
4 weeks
Measurement of body weight
大体时间：4 weeks

Body weight measured by body scale
4 weeks
Waist and hip circumference / waist to hip ratio
大体时间：4 weeks

Waist and hip circumference measured by tape measure
4 weeks
Systolic and diastolic blood pressure
大体时间：4 weeks

Systolic and diastolic blood pressure changes measurement by manometer
4 weeks
Body fat and lean mass
大体时间：4 weeks

Body fat and lean mass assessed by bioelectrical impendance analysis (BIA)
4 weeks
Energy expenditure and substrate oxidation rates
大体时间：4 weeks

Energy expenditure and substrate oxidation rates assessed by indirect calorimetry
4 weeks
Hepatic values (gamma-glutamyl transferase (GGT), aspartate aminotransferase (AST), alanine aminotransferase (ALT))
大体时间：4 weeks

GGT, AST, ALT etermined in fasting blood samples
4 weeks
Renal values (creatinine, urea, uric acid)
大体时间：4 weeks

Renal values determined in fasting blood samples
4 weeks
Intra- und inter-day glycemic variability
大体时间：4 weeks

Indices of intra- and inter-day glycemic variability assessed by continuous glucose monitoring (CGM)
4 weeks
Glucose levels in meal tolerance test (MTT)
大体时间：4 weeks

Glucose levels in blood samples collected in 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)
大体时间：4 weeks

Blood levels of metabolic hormones assessed in fasting state and during the MTT
4 weeks
Inflammatory markers and T cell populations analyses
大体时间：4 weeks

Level of the inflammatory markers IL-6, TNFa, MCP-1 and T cell populations in circulation and adipose tissue are assessed through blood analysis and fat biopsy
4 weeks
Satiety and hunger scores
大体时间：4 weeks

Satiety and hunger scores assessed using Visual Analog Scale (VAS with a scale of 1-100, where higher values correspond to stronger satiety/hunger)
4 weeks
Sleep/wake timing and sleep quality
大体时间：4 weeks

Sleep/wake timing and sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI score, which ranges from 0-21, where higher values correspond to worse sleep quality) and also monitored by an ActiGraph device
4 weeks
Physical activity
大体时间：4 weeks

24-h physical activity will be monitored by an ActiGraph device
4 weeks
Adipose tissue transcriptome
大体时间：4 weeks

RNA-Seq analysis of subcutaneous adipose tissue sample
4 weeks
Gene expression in peripheral blood mononuclear cells (PBMC)
大体时间：4 weeks

Expression of metabolic genes assessed by qPCR
4 weeks
Gut microbiota and microbiome-derived metabolites
大体时间：4 weeks

Determined in stool samples and blood plasma
4 weeks
Determination of decision behavior
大体时间：4 weeks

Impulsiveness assessed by decision making tasks on computer
4 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

German Institute of Human Nutrition

合作者

Charite University, Berlin, Germany
Helmholtz Zentrum München
Hasso Plattner Institute, Potsdam, Germany

调查人员

  • 首席研究员：Olga Ramich, PD Dr.、German Institute of Human Nutrition

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年4月12日

初级完成 (实际的)

2026年4月21日

研究完成 (估计的)

2027年2月28日

研究注册日期

首次提交

2024年3月15日

首先提交符合 QC 标准的

2024年4月21日

首次发布 (实际的)

2024年4月24日

研究记录更新

最后更新发布 (实际的)

2026年9月29日

上次提交的符合 QC 标准的更新

2026年9月26日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 90/2023

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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