Investigation of Urinary Biomarkers for the Diagnosis of Insulin Resistance

Insulin Resistance Clinical Trial

— BIOMUIR  

Official title:

Investigation of Urinary Biomarkers for the Diagnosis of Insulin Resistance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04010903
• Other study ID #: 19_0077
• Status: Recruiting
• Phase: N/A
• Start date: September 16, 2019
• Est. completion date: March 2023

Study information

• Verified date: March 2021
• Source: University Hospital, Montpellier
• Contact: ERIC RENARD, MD
• Phone: +33 467 338 384
• Email: e-renard[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: March 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance

Intervention

Diagnostic Test:
• assessment of biomarkers of insulin resistance
blood and urine sample collection for assays of BCAAs

Locations

Country	Name	City	State
France	UH Montpellier	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Centre National de la Recherche Scientifique, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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