Investigation of Urinary Biomarkers for the Diagnosis of Insulin Resistance

NCT ID: NCT04010903

Last Updated: 2024-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-16

Study Completion Date

2024-07-29

Brief Summary

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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

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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.

Conditions

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Insulin Resistance

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Cohort of subjects with/without overweight and with/without insulin resistance
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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HEALTHY SUBJECTS

SUBJECTS WITH BMI\<27 and HOMA\<4

Group Type EXPERIMENTAL

assessment of biomarkers of insulin resistance

Intervention Type DIAGNOSTIC_TEST

blood and urine sample collection for assays of BCAAs

OVERWEIGHT NON INSULINRESISTANT PATIENTS

SUBJECTS WITH BMI\>27 and HOMA\<4

Group Type EXPERIMENTAL

assessment of biomarkers of insulin resistance

Intervention Type DIAGNOSTIC_TEST

blood and urine sample collection for assays of BCAAs

OVERWEIGHT INSULINRESISTANT PATIENTS

SUBJECTS WITH BMI\>27 and HOMA\>4

Group Type EXPERIMENTAL

assessment of biomarkers of insulin resistance

Intervention Type DIAGNOSTIC_TEST

blood and urine sample collection for assays of BCAAs

Interventions

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assessment of biomarkers of insulin resistance

blood and urine sample collection for assays of BCAAs

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre National de la Recherche Scientifique, France

OTHER

Sponsor Role collaborator

Sys2Diag, Mixt laboratory CNRS/Alcediag, Montpellier

UNKNOWN

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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EMILIE BARDE

Role: STUDY_DIRECTOR

UH Montpellier

Locations

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UH Montpellier

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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19_0077

Identifier Type: -

Identifier Source: org_study_id

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