Clinical Trial: Observational Study of Blood Glucose Levels and Gut Microbiota in Healthy Individuals
Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational
Official Title: Observational Study of Blood Glucose Levels and Gut Microbiota in Healthy Individuals
Brief Summary:
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.
Detailed Summary: 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 th
Sponsor: Tel-Aviv Sourasky Medical Center
Current Primary Outcome: Blood glucose levels [ Time Frame: One week ]
Original Primary Outcome: Same as current
Current Secondary Outcome: DNA sequencing of the gut microbiota composition [ Time Frame: Before or during the glucose testing week ]
Original Secondary Outcome: Same as current
Information By: Tel-Aviv Sourasky Medical Center
Dates:
Date Received: May 26, 2013
Date Started: April 2013
Date Completion: April 2016
Last Updated: March 26, 2014
Last Verified: July 2013
