Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2026-01-01 @ 10:12 PM
Study NCT ID:
NCT04010903
Status:
COMPLETED
Last Update Posted:
2024-10-30
First Post:
2019-07-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Urinary Biomarkers for the Diagnosis of Insulin Resistance
Sponsor:
University Hospital, Montpellier
Organization:
Study Overview
Official Title:
Investigation of Urinary Biomarkers for the Diagnosis of Insulin Resistance
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIOMUIR
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: