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Investigation of Urinary Biomarkers for the Diagnosis of Insulin Resistance

Investigation of Urinary Biomarkers for the Diagnosis of Insulin Resistance

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04010903
Acronym
BIOMUIR
Enrollment
304
Registered
2019-07-08
Start date
2019-09-16
Completion date
2024-07-29
Last updated
2024-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance

Keywords

INSULIN RESISTANCE

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.

Interventions

DIAGNOSTIC_TESTassessment of biomarkers of insulin resistance

blood and urine sample collection for assays of BCAAs

Sponsors

Centre National de la Recherche Scientifique, France
CollaboratorOTHER
Sys2Diag, Mixt laboratory CNRS/Alcediag, Montpellier
CollaboratorUNKNOWN
University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Cohort of subjects with/without overweight and with/without insulin resistance

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation between urinary levels of BCAAs and HOMA indexthrough study completion, an average of two years and a halfIdentification of urinary BCAAs as markers of insulin resistance

Secondary

MeasureTime frameDescription
Correlation between blood and urine BCAAs levelsthrough study completion, an average of two years and a halfValidation of urinary BCAAs as biomarkers of insulin resistance
Correlation between urine BCAAs levels measured by enzymatic method (artificial vesicles) and classic methodthrough study completion, an average of two years and a halfMeasured 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 indexthrough study completion, an average of two years and a halfMeasured by enzymatic method (artificial vesicles) and HOMA index

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026