Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Personalized Medicine for Diabetes Prediction and Prevention of Complications

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2010 by Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
Technion, Israel Institute of Technology
Information provided by:
Rambam Health Care Campus Identifier:
First received: December 29, 2010
Last updated: December 30, 2010
Last verified: November 2010
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
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:

Further study details as provided by Rambam Health Care Campus:

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

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".

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01268813

Contact: Eddy Karnieli, MD +97248541606
Contact: Margalit Levy, BA +97248541606

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
Principal Investigator: Eddy Karnieli, MD Rambam Medicl Center, Technion
  More Information

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

Additional relevant MeSH terms:
Diabetes Mellitus
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Resistance
Hyperinsulinism processed this record on May 25, 2017