NCT01892956

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 8, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2015

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
Last Updated

June 23, 2020

Status Verified

June 1, 2020

Enrollment Period

2.1 years

First QC Date

May 26, 2013

Last Update Submit

June 21, 2020

Conditions

Nutritional and Metabolic DiseasesEndocrine System DiseasesDisorders of Environmental Origin

Outcome Measures

Primary Outcomes (1)

  • Blood glucose levels

    One week

Secondary Outcomes (1)

  • DNA sequencing of the gut microbiota composition

    Before or during the glucose testing week

Other Outcomes (3)

  • Change in postprandial glycemic responses (PPGR)

    Four weeks Crossover intervention

  • Change in Fructoseamine

    Four weeks Crossover intervention

  • Change in HbA1C

    Six months

Study Arms (2)

Healthy volunteers

Newly diagnosed T2DM

Newly diagnosed T2DM, who have not started yet medical treatment with glucose lowering medications

Other: Nutritional intervention

Interventions

Nutritional interventionOTHER

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

Newly diagnosed T2DM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Israeli residents and visitors

You may qualify if:

  • Healthy adults

You may not qualify if:

  • Under 18 years of age
  • Mental incompetence.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gastroenterology Institute

Tel Aviv, 64239, Israel

Location

Related Publications (3)

  • 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.

    PMID: 35135549DERIVED

  • 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.

    PMID: 26590418DERIVED

  • 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.

    PMID: 26229116DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood count, lipids, liver functions, CBP Stool sample for intestinal microbiota

MeSH Terms

Conditions

Nutritional and Metabolic DiseasesEndocrine System DiseasesDisorders of Environmental Origin

Study Officials

  • Zamir Halpern, MD

    Tel-Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2013

First Posted

July 8, 2013

Study Start

April 1, 2013

Primary Completion

April 30, 2015

Study Completion

October 30, 2019

Last Updated

June 23, 2020

Record last verified: 2020-06

Locations

IL(1)