MedPath

Personalized Medicine for Diabetes Prediction and Prevention of Complications

Phase 1
Conditions
Metabolic Syndrome
Diabetes
Interventions
Other: Breath analysis and blood analysis
Registration Number
NCT01268813
Lead Sponsor
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

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".

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
60
Inclusion Criteria
  • Metabolic Syndrome
  • Type 2 diabetes
  • Healthy volunteers with 20<Body Mass Index<25
Exclusion Criteria
  • Smoking
  • Chronic or acute lung disease

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Exhaled breath uptake blood testBreath analysis and blood analysisDiabetic patients receiving oral hypoglycemic drug will be tested for biomarkers in their breath and blood samples
Exhaled breath and blood testBreath analysis and blood analysisBreath 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.
Primary Outcome Measures
NameTimeMethod
Development of Diabetes or complication2 years
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Rambam Medical Center - Inst. Endocrinology, Diabetes & Metabolism

🇮🇱

Haifa, Israel

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