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Personalized Medicine for Diabetes Prediction and Prevention of Complications

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Rambam Health Care Campus.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Technion, Israel Institute of Technology
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01268813
First received: December 29, 2010
Last updated: December 30, 2010
Last verified: November 2010
History of Changes
  Purpose

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 Intervention Phase
Metabolic Syndrome
Diabetes
 Other: Breath analysis and blood analysis
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Personalized Medicine in Diabetes Using a Nanotechnology Platform

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Development of Diabetes or complication [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: February 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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".

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Prof. Eddy Karnieli, Rambam Medical Center
ClinicalTrials.gov Identifier: NCT01268813     History of Changes
Other Study ID Numbers: METASC011
Study First Received: December 29, 2010
Last Updated: December 30, 2010
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on May 21, 2013