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Personalized Medicine for Diabetes Prediction and Prevention of Complications

R

Rambam Health Care Campus

Status and phase

Unknown
Phase 1

Conditions

Diabetes
Metabolic Syndrome

Treatments

Other: Breath analysis and blood analysis

Study type

Interventional

Funder types

Other

Identifiers

NCT01268813
METASC011

Details and patient eligibility

About

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

Full 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".

Enrollment

60 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Metabolic Syndrome
  • Type 2 diabetes
  • Healthy volunteers with 20<Body Mass Index<25

Exclusion criteria

  • Smoking
  • Chronic or acute lung disease

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Exhaled breath uptake blood test
Experimental group
Description:
Diabetic patients receiving oral hypoglycemic drug will be tested for biomarkers in their breath and blood samples
Treatment:
Other: Breath analysis and blood analysis
Exhaled breath and blood test
No Intervention group
Description:
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.
Treatment:
Other: Breath analysis and blood analysis

Trial contacts and locations

1

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Central trial contact

Eddy Karnieli, MD; Margalit Levy, BA

Data sourced from clinicaltrials.gov

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