Investigation of Urinary Biomarkers for the Diagnosis of Insulin Resistance

Study Overview
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Brief Summary
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The study aims at the identification and the quantification of urinary branched-chain amino acids (BCAAs) by mass spectometry in healthy subjects and patients with insulin resistance and correlating urinary BCAAs with HOMA index. Blood and urine levels of BCAAs will be correlated with HOMA index to assess and quantify insulin resistance. Identification and quantification of urine BCAAs by an innovative method based on synthetic biology will also be performed. Correlations between mass spectometry and the innovative detection method of BCAAs will be searched.

Detailed Description
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Blood and urine samples will be collected in 330 persons to assess BCAAs levels and correlate them with HOMA index. Persons included will be: 110 persons with BMI>27 and HOMA >4 with no diabetes 110 persons with BMI>27 and HOMA < 4 with no diabetes 110 persons with BMI < 27 and HOMA <4 with no diabetes, including at least 50 men and 50 women, 30 aged 18-35, 30 aged 36-55, 30 aged 56-75. Urine BCAAs will be measured by both mass spectrometry and the innovative method based on synthetic biology.

Official Title
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Investigation of Urinary Biomarkers for the Diagnosis of Insulin Resistance

Conditions
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Insulin Resistance

Intervention / Treatment
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* Diagnostic Test: assessment of biomarkers of insulin resistance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: no diabetes according to studied subpopulations: BMI<27 and HOMA <4, BMI>27 and HOMA>4, BMI>27 and HOMA<4 Exclusion Criteria: pregnancy or lactation active or suspected chronic infection treatment affecting insulin sensitivity

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cohort of subjects with/without overweight and with/without insulin resistance
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HEALTHY SUBJECTS<br>SUBJECTS WITH BMI<27 and HOMA<4 | Diagnostic Test: assessment of biomarkers of insulin resistance<br>* blood and urine sample collection for assays of BCAAs<br>|
| Experimental: OVERWEIGHT NON INSULINRESISTANT PATIENTS<br>SUBJECTS WITH BMI>27 and HOMA<4 | Diagnostic Test: assessment of biomarkers of insulin resistance<br>* blood and urine sample collection for assays of BCAAs<br>|
| Experimental: OVERWEIGHT INSULINRESISTANT PATIENTS<br>SUBJECTS WITH BMI>27 and HOMA>4 | Diagnostic Test: assessment of biomarkers of insulin resistance<br>* blood and urine sample collection for assays of BCAAs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between urinary levels of BCAAs and HOMA index | Identification of urinary BCAAs as markers of insulin resistance | through study completion, an average of two years and a half | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between blood and urine BCAAs levels | Validation of urinary BCAAs as biomarkers of insulin resistance | through study completion, an average of two years and a half | 
| Correlation between urine BCAAs levels measured by enzymatic method (artificial vesicles) and classic method | Measured by enzymatic method (artificial vesicles) and classic method (standard LC-MS/MS) | through study completion, an average of two years and a half | 
| Correlation between urine BCAAs levels measured by enzymatic method (artificial vesicles) and HOMA index | Measured by enzymatic method (artificial vesicles) and HOMA index | through study completion, an average of two years and a half | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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INSULIN RESISTANCE