Investigation of Urinary Biomarkers for the Diagnosis of Insulin Resistance (BIOMUIR)

University Hospital Center (CHU)

Status: Completed

Conditions: Insulin Resistance

Treatments: Diagnostic Test: assessment of biomarkers of insulin resistance

Study type: Interventional

Funder types: Other

Identifiers

NCT04010903

19_0077

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 304 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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304 participants in 3 patient groups

HEALTHY SUBJECTS

Experimental group

Description:

SUBJECTS WITH BMI\<27 and HOMA\<4

Treatment:

Diagnostic Test: assessment of biomarkers of insulin resistance

OVERWEIGHT NON INSULINRESISTANT PATIENTS

Experimental group

Description:

SUBJECTS WITH BMI\>27 and HOMA\<4

Treatment:

Diagnostic Test: assessment of biomarkers of insulin resistance

OVERWEIGHT INSULINRESISTANT PATIENTS

Experimental group

Description:

SUBJECTS WITH BMI\>27 and HOMA\>4

Treatment:

Diagnostic Test: assessment of biomarkers of insulin resistance