- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01892956
Observational Study of Blood Glucose Levels and Gut Microbiota in Healthy Individuals
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Tel-Aviv, Israel, 64239
- Gastroenterology Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Healthy adults
Exclusion Criteria:
- Under 18 years of age
- Mental incompetence.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy volunteers
|
|
Newly diagnosed T2DM
Newly diagnosed T2DM, who have not started yet medical treatment with glucose lowering medications
|
2 dietary interventions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood glucose levels
Time Frame: One week
|
One week
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
DNA sequencing of the gut microbiota composition
Time Frame: Before or during the glucose testing week
|
Before or during the glucose testing week
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in postprandial glycemic responses (PPGR)
Time Frame: Four weeks Crossover intervention
|
Measured only in newly diagnosed T2DM patients
|
Four weeks Crossover intervention
|
Change in Fructoseamine
Time Frame: Four weeks Crossover intervention
|
Measured only in newly diagnosed T2DM patients
|
Four weeks Crossover intervention
|
Change in HbA1C
Time Frame: Six months
|
Measured only in newly diagnosed T2DM patients
|
Six months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Zamir Halpern, MD, Tel-Aviv Sourasky Medical Center
Publications and helpful links
General Publications
- Rein M, Ben-Yacov O, Godneva A, Shilo S, Zmora N, Kolobkov D, Cohen-Dolev N, Wolf BC, Kosower N, Lotan-Pompan M, Weinberger A, Halpern Z, Zelber-Sagi S, Elinav E, Segal E. Effects of personalized diets by prediction of glycemic responses on glycemic control and metabolic health in newly diagnosed T2DM: a randomized dietary intervention pilot trial. BMC Med. 2022 Feb 9;20(1):56. doi: 10.1186/s12916-022-02254-y.
- Zeevi D, Korem T, Zmora N, Israeli D, Rothschild D, Weinberger A, Ben-Yacov O, Lador D, Avnit-Sagi T, Lotan-Pompan M, Suez J, Mahdi JA, Matot E, Malka G, Kosower N, Rein M, Zilberman-Schapira G, Dohnalova L, Pevsner-Fischer M, Bikovsky R, Halpern Z, Elinav E, Segal E. Personalized Nutrition by Prediction of Glycemic Responses. Cell. 2015 Nov 19;163(5):1079-1094. doi: 10.1016/j.cell.2015.11.001.
- Korem T, Zeevi D, Suez J, Weinberger A, Avnit-Sagi T, Pompan-Lotan M, Matot E, Jona G, Harmelin A, Cohen N, Sirota-Madi A, Thaiss CA, Pevsner-Fischer M, Sorek R, Xavier R, Elinav E, Segal E. Growth dynamics of gut microbiota in health and disease inferred from single metagenomic samples. Science. 2015 Sep 4;349(6252):1101-1106. doi: 10.1126/science.aac4812. Epub 2015 Jul 30.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TASMC-12-ZH-658
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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