Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT04010903
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.
Study:
NCT04010903
Study Brief:
Protocol Section:
NCT04010903