Observational Study of Blood Glucose Levels and Gut Microbiota in Healthy Individuals
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|ClinicalTrials.gov Identifier: NCT01892956|
Recruitment Status : Completed
First Posted : July 8, 2013
Last Update Posted : June 23, 2020
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.
|Condition or disease||Intervention/treatment|
|Nutritional and Metabolic Diseases Endocrine System Diseases Disorders of Environmental Origin||Other: Nutritional intervention|
|Study Type :||Observational|
|Estimated Enrollment :||2000 participants|
|Official Title:||Observational Study of Blood Glucose Levels and Gut Microbiota in Healthy Individuals|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||April 30, 2015|
|Actual Study Completion Date :||October 30, 2019|
Newly diagnosed T2DM
Newly diagnosed T2DM, who have not started yet medical treatment with glucose lowering medications
Other: Nutritional intervention
2 dietary interventions
- Blood glucose levels [ Time Frame: One week ]
- DNA sequencing of the gut microbiota composition [ Time Frame: Before or during the glucose testing week ]
- Change in postprandial glycemic responses (PPGR) [ Time Frame: Four weeks Crossover intervention ]Measured only in newly diagnosed T2DM patients
- Change in Fructoseamine [ Time Frame: Four weeks Crossover intervention ]Measured only in newly diagnosed T2DM patients
- Change in HbA1C [ Time Frame: Six months ]Measured only in newly diagnosed T2DM patients
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01892956
|Tel-Aviv, Israel, 64239|
|Principal Investigator:||Zamir Halpern, MD||Tel-Aviv Sourasky Medical Center|