Investigation of Urinary Biomarkers for the Diagnosis of Insulin Resistance

Not Applicable

Completed

• Conditions: Insulin Resistance
• Interventions: Diagnostic Test: assessment of biomarkers of insulin resistance

• Registration Number: NCT04010903
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-07-02
• Study First Submitted QC: 2019-07-04
• Study First Posted: 2019-07-08
• Study Start: 2019-09-16
• Primary Completion: 2023-09-30
• Study Completion: 2024-07-29
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 304

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OVERWEIGHT NON INSULINRESISTANT PATIENTS	assessment of biomarkers of insulin resistance	SUBJECTS WITH BMI\>27 and HOMA\<4
OVERWEIGHT INSULINRESISTANT PATIENTS	assessment of biomarkers of insulin resistance	SUBJECTS WITH BMI\>27 and HOMA\>4
HEALTHY SUBJECTS	assessment of biomarkers of insulin resistance	SUBJECTS WITH BMI\<27 and HOMA\<4

Primary Outcome Measures

Name	Time	Method
Correlation between urinary levels of BCAAs and HOMA index	through study completion, an average of two years and a half	Identification of urinary BCAAs as markers of insulin resistance

Secondary Outcome Measures

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

Trial Locations

Locations (1)

UH Montpellier; 🇫🇷 Montpellier, France