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Personalized Medicine for Diabetes Prediction and Prevention of Complications

Primary Purpose

Metabolic Syndrome, Diabetes

Status

Unknown status

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

Breath analysis and blood analysis

About this trial

This is an interventional diagnostic trial for Metabolic Syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Rambam Medical Center - Inst. Endocrinology, Diabetes & Metabolism

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exhaled breath uptake blood test

Exhaled breath and blood test

Arm Description

Diabetic patients receiving oral hypoglycemic drug will be tested for biomarkers in their breath and blood samples

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.

Outcomes

Primary Outcome Measures

Development of Diabetes or complication

Secondary Outcome Measures

Full Information

NCT ID

NCT01268813

First Posted

December 29, 2010

Last Updated

December 30, 2010

Sponsor

Rambam Health Care Campus

Collaborators

Technion, Israel Institute of Technology

1. Study Identification

Unique Protocol Identification Number

NCT01268813

Brief Title

Personalized Medicine for Diabetes Prediction and Prevention of Complications

Official Title

Personalized Medicine in Diabetes Using a Nanotechnology Platform

Study Type

Interventional

2. Study Status

Record Verification Date

November 2010

Overall Recruitment Status

Unknown status

Study Start Date

February 2011 (undefined)

Primary Completion Date

December 2012 (Anticipated)

Study Completion Date

March 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Rambam Health Care Campus

Collaborators

Technion, Israel Institute of Technology

4. Oversight

Data Monitoring Committee

5. Study Description

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".

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Syndrome, Diabetes

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Exhaled breath uptake blood test

Arm Type

Experimental

Arm Description

Diabetic patients receiving oral hypoglycemic drug will be tested for biomarkers in their breath and blood samples

Arm Title

Exhaled breath and blood test

Arm Type

No Intervention

Arm 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.

Intervention Type

Other

Intervention Name(s)

Breath analysis and blood analysis

Other Intervention Name(s)

nanothecnology platform

Intervention Description

Exhaled breath and blood samples will be collected and further tested using Gas Chromatography-Mass Spectroscopy system.

Primary Outcome Measure Information:

Title

Development of Diabetes or complication

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Metabolic Syndrome Type 2 diabetes Healthy volunteers with 20<Body Mass Index<25 Exclusion Criteria: Smoking Chronic or acute lung disease

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Eddy Karnieli, MD

Phone

+97248541606

eddy@rambam.health.gov.il

First Name & Middle Initial & Last Name or Official Title & Degree

Margalit Levy, BA

Phone

+97248541606

endo@rambam.health.gov.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eddy Karnieli, MD

Organizational Affiliation

Rambam Medicl Center, Technion

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rambam Medical Center - Inst. Endocrinology, Diabetes & Metabolism

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eddy Karnieli, MD

First Name & Middle Initial & Last Name & Degree

Sagit Zolotov, MD

12. IPD Sharing Statement

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Personalized Medicine for Diabetes Prediction and Prevention of Complications

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