Personalized Medicine for Diabetes Prediction and Prevention of Complications

December 30, 2010 updated by: Rambam Health Care Campus

Personalized Medicine in Diabetes Using a Nanotechnology Platform

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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".

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel, 31096
        • Rambam Medical Center - Inst. Endocrinology, Diabetes & Metabolism

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Smoking
  • Chronic or acute lung disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exhaled breath uptake blood test
Diabetic patients receiving oral hypoglycemic drug will be tested for biomarkers in their breath and blood samples
Other: Breath analysis and blood analysis
Exhaled breath and blood samples will be collected and further tested using Gas Chromatography-Mass Spectroscopy system.
Other Names:
  • nanothecnology platform
No Intervention: 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.
Other: Breath analysis and blood analysis
Exhaled breath and blood samples will be collected and further tested using Gas Chromatography-Mass Spectroscopy system.
Other Names:
  • nanothecnology platform

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Development of Diabetes or complication
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Collaborators

Technion, Israel Institute of Technology

Investigators

  • Principal Investigator: Eddy Karnieli, MD, Rambam Medicl Center, Technion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

March 1, 2013

Study Registration Dates

First Submitted

December 29, 2010

First Submitted That Met QC Criteria

December 30, 2010

First Posted (Estimate)

December 31, 2010

Study Record Updates

Last Update Posted (Estimate)

December 31, 2010

Last Update Submitted That Met QC Criteria

December 30, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METASC011

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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