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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04010903
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : November 2, 2020
Sponsor:
Collaborator:
Centre National de la Recherche Scientifique, France
Information provided by (Responsible Party):
University Hospital, Montpellier

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.


Condition or disease Intervention/treatment Phase
Insulin Resistance Diagnostic Test: assessment of biomarkers of insulin resistance Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cohort of subjects with/without overweight and with/without insulin resistance
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Investigation of Urinary Biomarkers for the Diagnosis of Insulin Resistance
Actual Study Start Date : September 16, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010903


Contacts
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Contact: ERIC RENARD, MD +33 467 338 384 e-renard@chu-montpellier.fr

Locations
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France
UH Montpellier Recruiting
Montpellier, France, 34295
Contact: ERIC RENARD, MD    +33467338384    e-renard@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
Centre National de la Recherche Scientifique, France
Investigators
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Study Director: EMILIE BARDE UH Montpellier
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04010903    
Other Study ID Numbers: 19_0077
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: November 2, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
INSULIN RESISTANCE
Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs