Personalized Medicine for Diabetes Prediction and Prevention of Complications
Personalized Medicine in Diabetes Using a Nanotechnology Platform
1 other identifier
interventional
60
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2011
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 29, 2010
CompletedFirst Posted
Study publicly available on registry
December 31, 2010
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedDecember 31, 2010
November 1, 2010
1.8 years
December 29, 2010
December 30, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Development of Diabetes or complication
2 years
Study Arms (2)
Exhaled breath uptake blood test
EXPERIMENTALDiabetic patients receiving oral hypoglycemic drug will be tested for biomarkers in their breath and blood samples
Exhaled breath and blood test
NO INTERVENTIONBreath 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.
Interventions
Exhaled breath and blood samples will be collected and further tested using Gas Chromatography-Mass Spectroscopy system.
Eligibility Criteria
You may qualify if:
- Metabolic Syndrome
- Type 2 diabetes
- Healthy volunteers with 20\<Body Mass Index\<25
You may not qualify if:
- Smoking
- Chronic or acute lung disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rambam Medical Center - Inst. Endocrinology, Diabetes & Metabolism
Haifa, 31096, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eddy Karnieli, MD
Rambam Medicl Center, Technion
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 29, 2010
First Posted
December 31, 2010
Study Start
February 1, 2011
Primary Completion
December 1, 2012
Study Completion
March 1, 2013
Last Updated
December 31, 2010
Record last verified: 2010-11