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Personalized Medicine for Diabetes Prediction and Prevention of Complications

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ClinicalTrials.gov Identifier: NCT01268813
Recruitment Status : Unknown
Verified November 2010 by Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
First Posted : December 31, 2010
Last Update Posted : December 31, 2010
Sponsor:
Collaborator:
Technion, Israel Institute of Technology
Information provided by:
Rambam Health Care Campus

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Diabetes Other: Breath analysis and blood analysis Phase 1

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Personalized Medicine in Diabetes Using a Nanotechnology Platform
Study Start Date : February 2011
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: 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 Name: nanothecnology platform



Primary Outcome Measures :
  1. Development of Diabetes or complication [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Smoking
  • Chronic or acute lung disease

Information from the National Library of Medicine

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): NCT01268813


Contacts
Contact: Eddy Karnieli, MD +97248541606 eddy@rambam.health.gov.il
Contact: Margalit Levy, BA +97248541606 endo@rambam.health.gov.il

Locations
Israel
Rambam Medical Center - Inst. Endocrinology, Diabetes & Metabolism Not yet recruiting
Haifa, Israel, 31096
Principal Investigator: Eddy Karnieli, MD         
Sub-Investigator: Sagit Zolotov, MD         
Sponsors and Collaborators
Rambam Health Care Campus
Technion, Israel Institute of Technology
Investigators
Principal Investigator: Eddy Karnieli, MD Rambam Medicl Center, Technion

Responsible Party: Prof. Eddy Karnieli, Rambam Medical Center
ClinicalTrials.gov Identifier: NCT01268813     History of Changes
Other Study ID Numbers: METASC011
First Posted: December 31, 2010    Key Record Dates
Last Update Posted: December 31, 2010
Last Verified: November 2010

Additional relevant MeSH terms:
Diabetes Mellitus
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Resistance
Hyperinsulinism