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Observational Study of Blood Glucose Levels and Gut Microbiota in Healthy Individuals

2020年6月21日 更新者:Tel-Aviv Sourasky Medical Center

Categorization of glucose levels into 'healthy', 'pre-diabetic' or 'diabetic' is increasingly seen as artificial. Furthermore, most micro and macrovascular complications may be present already at the pre-diabetic stage.

Hyperglycemia, pre-diabetes and impaired glucose tolerance (IGT) are fully reversible, thus, maintaining normal blood sugar levels is crucial for the prevention and control of diabetes and the various other consequences of the metabolic syndrome. Only interventions that are individually tailored can achieve proper glycemic control, and the glycemic index (GI), which quantifies the glycemic response to particular foods, was developed for this purpose.

In this study the investigators will characterize the blood glucose responses and microbiota of healthy individuals, aiming to assess the influence of food intake on gut microbiota and the influence of gut microbiota on glycemic responses.

研究概览

详细说明

Advances in characterization and diagnosis of type 2 Diabetes Mellitus (T2DM) led to the identification of a rapidly growing number of individuals who fall under a 'gray zone' of disturbed yet non-diabetic fasting or post-prandial glucose levels, termed pre-diabetes, impaired glucose tolerance (IGT), or simply individuals with fasting or post-prandial glucose levels in the upper-normal range. All of these poorly characterized groups are at substantial risk for long-term medical complications. Consequently, categorization of glucose levels into 'healthy', 'pre-diabetic' or 'diabetic' is increasingly seen as artificial, and both glucose levels and risk of diabetes are considered as continuous variables. In the past three decades, glucose levels have been rapidly increasing in the overall population in developed and developing countries alike, resulting in a sharp incline in the prevalence of both pre-diabetes and IGT. In the U.S. alone, the estimates are that 79 million people have been affected by 2010, and the projections suggest that 472 million people will be affected worldwide by 2030. Up to 70-90% of those individuals with IGT or pre-diabetes proceed to develop full-blown T2DM. Furthermore, most micro and macrovascular complications, including chronic renal disease, sensory and autonomic neuropathy and diabetic retinopathy, may be present already at the pre-diabetic stage. In addition, pre-diabetic hyperglycemia is linked to multiple manifestations of the metabolic syndrome, such as obesity, hypertension and hypertriglyceridemia, and is an independent risk factor for major macrovascular events such as coronary heart disease and total vascular mortality. Despite these serious risks, and in striking contrast to overt diabetes, hyperglycemia, pre-diabetes and IGT are fully reversible, with up to 55- 80% of individuals reported to revert to normoglycemia and normoinsulinemia upon life-style modifications. Thus, maintaining normal blood sugar levels is crucial for the prevention and control of diabetes and the various other consequences of the metabolic syndrome. The glycemic index (GI), which quantifies the glycemic response to particular foods, was developed for this purpose, but low GI diets have poor predictive value for T2DM development in both the healthy and pre-diabetic settings. This limited success of the GI index may be an inherent problem to any method that assigns a single value to a given food, since individuals vary greatly in their glycemic response to the same food, and even the nature of variation is currently poorly characterized. Along these lines, emerging data from our group and others strongly suggest that proper control and modulation of the glycemic response to foods relies on person-specific factors and thus, only interventions that are individually tailored can achieve proper glycemic control. Although variations in host-related genetic factors affect the normal and post-prandial glycemic response, these factors are estimated to account for only ~10% of the metabolic phenotype. This low estimate is reinforced by the growing incidence of diabetes in recent years. In contrast, increasing importance in glucose homeostasis is being attributed to environmental factors such as the composition and function of the cumulative intestinal microbiota. This immense and poorly understood ecosystem of over 1500 species of bacteria, fungi, and their viruses are modulated by diet, and in turn, profoundly regulate host metabolic processes. Evidence for this host-microbiota interplay includes a distinct microbiota composition found in T2DM patients; and numerous alterations in the microbiome composition and expression of major metabolic pathways found one day after switching from a plant polysaccharide-based diet to a sugary "western" diet in germ-free mice inoculated with a human microbiota. Furthermore, microbiota-induced local gut inflammation was recently linked to a propensity for glucose intolerance, which was reversible upon antibiotic treatment. In this study the investigators will characterize the blood glucose responses and microbiota of healthy individuals, aiming to assess the influence of food intake on gut microbiota and the influence of gut microbiota on glycemic responses.

研究类型

观察性的

注册 (预期的)

2000

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

      • Tel-Aviv、以色列、64239
        • Gastroenterology Institute

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 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Israeli residents and visitors

描述

Inclusion Criteria:

  • Healthy adults

Exclusion Criteria:

  • Under 18 years of age
  • Mental incompetence.

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

队列和干预

团体/队列
干预/治疗
健康志愿者
Newly diagnosed T2DM
Newly diagnosed T2DM, who have not started yet medical treatment with glucose lowering medications

2 dietary interventions

  1. personalized diet based on algorithm predictions of glucose response to foods
  2. Mediterranean-style diet

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Blood glucose levels
大体时间:One week
One week

次要结果测量

结果测量
大体时间
DNA sequencing of the gut microbiota composition
大体时间:Before or during the glucose testing week
Before or during the glucose testing week

其他结果措施

结果测量
措施说明
大体时间
Change in postprandial glycemic responses (PPGR)
大体时间:Four weeks Crossover intervention
Measured only in newly diagnosed T2DM patients
Four weeks Crossover intervention
Change in Fructoseamine
大体时间:Four weeks Crossover intervention
Measured only in newly diagnosed T2DM patients
Four weeks Crossover intervention
Change in HbA1C
大体时间:Six months
Measured only in newly diagnosed T2DM patients
Six months

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。

调查人员

  • 首席研究员:Zamir Halpern, MD、Tel-Aviv Sourasky Medical Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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

2013年4月1日

初级完成 (实际的)

2015年4月30日

研究完成 (实际的)

2019年10月30日

研究注册日期

首次提交

2013年5月26日

首先提交符合 QC 标准的

2013年7月1日

首次发布 (估计)

2013年7月8日

研究记录更新

最后更新发布 (实际的)

2020年6月23日

上次提交的符合 QC 标准的更新

2020年6月21日

最后验证

2020年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • TASMC-12-ZH-658

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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