Personalized Medicine for Diabetes Prediction and Prevention of Complications

NCT ID: NCT01268813

Last Updated: 2010-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-03-31

Brief Summary

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The metabolic syndrome is a collection of related risk factors that predispose to the development of type 2 diabetes Mellitus and cardiovascular disease. The investigators will examine the hypothesis that the metabolic and genomic characteristics of patients with metabolic syndrome and/or diabetes that are at risk for developing complications differ from each other and can be detected using specific biomarkers in blood or in the exhaled breath. Early detection of these individuals will enable personalized treatment to prevent and treat diabetes and its complications

Detailed Description

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Breath samples will be collected in inert respiratory bag from diabetic and healthy volunteers, and analyzed using a chamber containing nano-chemical sensors. These samples together with blood samples will additionally be characterized using Gas Chromatography-Mass Spectroscopy "GC-MS".

Conditions

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Metabolic Syndrome Diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Exhaled breath uptake blood test

Diabetic patients receiving oral hypoglycemic drug will be tested for biomarkers in their breath and blood samples

Group Type EXPERIMENTAL

Breath analysis and blood analysis

Intervention Type OTHER

Exhaled breath and blood samples will be collected and further tested using Gas Chromatography-Mass Spectroscopy system.

Exhaled breath and blood test

Breath and blood samples will be collected from healthy volunteers and analyzed using Gas Chromatography-Mass Spectroscopy. The results will be compared to the experimental arm.

Group Type NO_INTERVENTION

Breath analysis and blood analysis

Intervention Type OTHER

Exhaled breath and blood samples will be collected and further tested using Gas Chromatography-Mass Spectroscopy system.

Interventions

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Breath analysis and blood analysis

Exhaled breath and blood samples will be collected and further tested using Gas Chromatography-Mass Spectroscopy system.

Intervention Type OTHER

Other Intervention Names

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nanothecnology platform

Eligibility Criteria

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Inclusion Criteria

* Metabolic Syndrome
* Type 2 diabetes
* Healthy volunteers with 20\<Body Mass Index\<25

Exclusion Criteria

* Smoking
* Chronic or acute lung disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Technion, Israel Institute of Technology

OTHER

Sponsor Role collaborator

Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Rambam Medical Center

Principal Investigators

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Eddy Karnieli, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Medicl Center, Technion

Locations

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Rambam Medical Center - Inst. Endocrinology, Diabetes & Metabolism

Haifa, , Israel

Site Status

Countries

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Israel

Central Contacts

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Eddy Karnieli, MD

Role: CONTACT

Phone: +97248541606

Email: [email protected]

Margalit Levy, BA

Role: CONTACT

Phone: +97248541606

Email: [email protected]

Other Identifiers

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METASC011

Identifier Type: -

Identifier Source: org_study_id