Completed

BIOMUIRInvestigation of Urinary Biomarkers for the Diagnosis of Insulin Resistance

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What is being tested

assessment of biomarkers of insulin resistance

Diagnostic Test
Who is being recruted

Hyperinsulinism+2

+ Insulin Resistance

+ Metabolic Diseases

From 18 to 75 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: September 2019
See protocol details

Summary

Principal SponsorUniversity Hospital, Montpellier
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 16, 2019

Actual date on which the first participant was enrolled.

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 TitleInvestigation of Urinary Biomarkers for the Diagnosis of Insulin Resistance
NCT04010903
Principal SponsorUniversity Hospital, Montpellier
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

304 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

HyperinsulinismInsulin ResistanceMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

2 inclusion criteria required to participate
no diabetes
according to studied subpopulations: BMI<27 and HOMA <4, BMI>27 and HOMA>4, BMI>27 and HOMA<4
3 exclusion criteria prevent from participating
pregnancy or lactation
active or suspected chronic infection
treatment affecting insulin sensitivity

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
SUBJECTS WITH BMI\<27 and HOMA\<4

Group II

Experimental
SUBJECTS WITH BMI\>27 and HOMA\>4

Group III

Experimental
SUBJECTS WITH BMI\>27 and HOMA\<4

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

UH Montpellier

Montpellier, FranceOpen UH Montpellier in Google Maps
CompletedOne Study Center
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