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

Primary Purpose

Insulin Resistance

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
assessment of biomarkers of insulin resistance
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Insulin Resistance focused on measuring INSULIN RESISTANCE

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UH MontpellierRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

HEALTHY SUBJECTS

OVERWEIGHT NON INSULINRESISTANT PATIENTS

OVERWEIGHT INSULINRESISTANT PATIENTS

Arm Description

SUBJECTS WITH BMI<27 and HOMA<4

SUBJECTS WITH BMI>27 and HOMA<4

SUBJECTS WITH BMI>27 and HOMA>4

Outcomes

Primary Outcome Measures

Correlation between urinary levels of BCAAs and HOMA index
Identification of urinary BCAAs as markers of insulin resistance

Secondary Outcome Measures

Correlation between blood and urine BCAAs levels
Validation of urinary BCAAs as biomarkers of insulin resistance
Correlation between urine BCAAs levels measured by enzymatic method (artificial vesicles) and classic method
Measured 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 index
Measured by enzymatic method (artificial vesicles) and HOMA index

Full Information

First Posted
July 2, 2019
Last Updated
March 29, 2021
Sponsor
University Hospital, Montpellier
Collaborators
Centre National de la Recherche Scientifique, France
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1. Study Identification

Unique Protocol Identification Number
NCT04010903
Brief Title
Investigation of Urinary Biomarkers for the Diagnosis of Insulin Resistance
Acronym
BIOMUIR
Official Title
Investigation of Urinary Biomarkers for the Diagnosis of Insulin Resistance
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 16, 2019 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
Centre National de la Recherche Scientifique, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance
Keywords
INSULIN RESISTANCE

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cohort of subjects with/without overweight and with/without insulin resistance
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HEALTHY SUBJECTS
Arm Type
Experimental
Arm Description
SUBJECTS WITH BMI<27 and HOMA<4
Arm Title
OVERWEIGHT NON INSULINRESISTANT PATIENTS
Arm Type
Experimental
Arm Description
SUBJECTS WITH BMI>27 and HOMA<4
Arm Title
OVERWEIGHT INSULINRESISTANT PATIENTS
Arm Type
Experimental
Arm Description
SUBJECTS WITH BMI>27 and HOMA>4
Intervention Type
Diagnostic Test
Intervention Name(s)
assessment of biomarkers of insulin resistance
Intervention Description
blood and urine sample collection for assays of BCAAs
Primary Outcome Measure Information:
Title
Correlation between urinary levels of BCAAs and HOMA index
Description
Identification of urinary BCAAs as markers of insulin resistance
Time Frame
through study completion, an average of two years and a half
Secondary Outcome Measure Information:
Title
Correlation between blood and urine BCAAs levels
Description
Validation of urinary BCAAs as biomarkers of insulin resistance
Time Frame
through study completion, an average of two years and a half
Title
Correlation between urine BCAAs levels measured by enzymatic method (artificial vesicles) and classic method
Description
Measured by enzymatic method (artificial vesicles) and classic method (standard LC-MS/MS)
Time Frame
through study completion, an average of two years and a half
Title
Correlation between urine BCAAs levels measured by enzymatic method (artificial vesicles) and HOMA index
Description
Measured by enzymatic method (artificial vesicles) and HOMA index
Time Frame
through study completion, an average of two years and a half

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ERIC RENARD, MD
Phone
+33 467 338 384
Email
e-renard@chu-montpellier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
EMILIE BARDE
Organizational Affiliation
UH Montpellier
Official's Role
Study Director
Facility Information:
Facility Name
UH Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ERIC RENARD, MD
Phone
+33467338384
Email
e-renard@chu-montpellier.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Investigation of Urinary Biomarkers for the Diagnosis of Insulin Resistance

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