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Completed

NCT Number: NCT04010903

Investigation of Urinary Biomarkers for the Diagnosis of Insulin Resistance

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.

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Key information

Conditions

Insulin Resistance Glucose Metabolism Disorders Hyperinsulinism Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UH Montpellier

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

assessment of biomarkers of insulin resistance

Diagnostic Test

blood and urine sample collection for assays of BCAAs

Primary outcomes

  1. Correlation between urinary levels of BCAAs and HOMA index

    Time frame: through study completion, an average of two years and a half

    Identification of urinary BCAAs as markers of insulin resistance

Secondary outcomes

  1. Correlation between blood and urine BCAAs levels

    Time frame: through study completion, an average of two years and a half

    Validation of urinary BCAAs as biomarkers of insulin resistance

  2. Correlation between urine BCAAs levels measured by enzymatic method (artificial vesicles) and classic method

    Time frame: through study completion, an average of two years and a half

    Measured by enzymatic method (artificial vesicles) and classic method (standard LC-MS/MS)

  3. Correlation between urine BCAAs levels measured by enzymatic method (artificial vesicles) and HOMA index

    Time frame: through study completion, an average of two years and a half

    Measured by enzymatic method (artificial vesicles) and HOMA index

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Centre National de la Recherche Scientifique, France
  • Sys2Diag, Mixt laboratory CNRS/Alcediag, Montpellier

Registry information

Acronym: BIOMUIR

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Jul 8, 2019
Registry last updated
Oct 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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