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| Sponsor: | Rambam Health Care Campus |
|---|---|
| Collaborator: |
Technion, Israel Institute of Technology |
| Information provided by: | Rambam Health Care Campus |
| ClinicalTrials.gov Identifier: | NCT01268813 |
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 I |
| 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 |
| 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
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Eddy Karnieli, MD | +97248541606 | eddy@rambam.health.gov.il |
| Contact: Margalit Levy, BA | +97248541606 | endo@rambam.health.gov.il |
| Israel | |
| Rambam Medical Center - Inst. Endocrinology, Diabetes & Metabolism | Not yet recruiting |
| Haifa, Israel, 31096 | |
| Principal Investigator: Eddy Karnieli, MD | |
| Sub-Investigator: Sagit Zolotov, MD | |
| Principal Investigator: | Eddy Karnieli, MD | Rambam Medicl Center, Technion |
More Information
| 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 |
|
Diabetes Mellitus Metabolic Syndrome X Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Insulin Resistance Hyperinsulinism |
