Investigation of Urinary Biomarkers for the Diagnosis of Insulin Resistance

NCT04010903 | Completed

• 1 other identifier: 19_0077
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulin Resistance

Keywords

INSULIN RESISTANCE

Outcome Measures

Primary Outcomes (1)

• Correlation between urinary levels of BCAAs and HOMA index

  Identification of urinary BCAAs as markers of insulin resistance

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

Secondary Outcomes (3)

• Correlation between blood and urine BCAAs levels

  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

  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

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

Study Arms (3)

HEALTHY SUBJECTS

EXPERIMENTAL

SUBJECTS WITH BMI\<27 and HOMA\<4

Diagnostic Test: assessment of biomarkers of insulin resistance

OVERWEIGHT NON INSULINRESISTANT PATIENTS

EXPERIMENTAL

SUBJECTS WITH BMI\>27 and HOMA\<4

Diagnostic Test: assessment of biomarkers of insulin resistance

OVERWEIGHT INSULINRESISTANT PATIENTS

EXPERIMENTAL

SUBJECTS WITH BMI\>27 and HOMA\>4

Diagnostic Test: assessment of biomarkers of insulin resistance

Interventions

assessment of biomarkers of insulin resistance DIAGNOSTIC_TEST

blood and urine sample collection for assays of BCAAs

HEALTHY SUBJECTS; OVERWEIGHT INSULINRESISTANT PATIENTS; OVERWEIGHT NON INSULINRESISTANT PATIENTS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• no diabetes
• according to studied subpopulations: BMI\<27 and HOMA \<4, BMI\>27 and HOMA\>4, BMI\>27 and HOMA\<4

You may not qualify if:

• pregnancy or lactation
• active or suspected chronic infection
• treatment affecting insulin sensitivity

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Centre National de la Recherche Scientifique, France: collaborator
• Sys2Diag, Mixt laboratory CNRS/Alcediag, Montpellier: collaborator

Study Sites (1)

UH Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• EMILIE BARDE

  UH Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cohort of subjects with/without overweight and with/without insulin resistance

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 8, 2019
• Study Start: September 16, 2019
• Primary Completion: September 30, 2023
• Study Completion: July 29, 2024
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)