Investigation of Urinary Biomarkers for the Diagnosis of Insulin Resistance (BIOMUIR)

March 29, 2021 updated by: University Hospital, Montpellier

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

330

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HEALTHY SUBJECTS
SUBJECTS WITH BMI<27 and HOMA<4
Diagnostic test: assessment of biomarkers of insulin resistance
blood and urine sample collection for assays of BCAAs
Experimental: OVERWEIGHT NON INSULINRESISTANT PATIENTS
SUBJECTS WITH BMI>27 and HOMA<4
Diagnostic test: assessment of biomarkers of insulin resistance
blood and urine sample collection for assays of BCAAs
Experimental: OVERWEIGHT INSULINRESISTANT PATIENTS
SUBJECTS WITH BMI>27 and HOMA>4
Diagnostic test: assessment of biomarkers of insulin resistance
blood and urine sample collection for assays of BCAAs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of two years and a half

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of two years and a half
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)
through study completion, an average of two years and a half
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
through study completion, an average of two years and a half

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Collaborators

Centre National de la Recherche Scientifique, France

Investigators

  • Study Director: EMILIE BARDE, UH Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2019

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

July 2, 2019

First Submitted That Met QC Criteria

July 4, 2019

First Posted (Actual)

July 8, 2019

Study Record Updates

Last Update Posted (Actual)

March 30, 2021

Last Update Submitted That Met QC Criteria

March 29, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19_0077

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Insulin Resistance

Clinical Trials on assessment of biomarkers of insulin resistance

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe