Insulin ResistanceBIOMUIRNCT04010903
Investigation of Urinary Biomarkers for the Diagnosis of Insulin Resistance
A study testing assessment of biomarkers of insulin resistance in people with Insulin Resistance, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- assessment of biomarkers of insulin resistance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteFrance
- Study dates
- 16 Sep 2019to 29 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- no diabetes
- according to studied subpopulations: BMI<27 and HOMA <4, BMI>27 and HOMA>4, BMI>27 and HOMA<4
Who cannot join
- pregnancy or lactation
- active or suspected chronic infection
- treatment affecting insulin sensitivity
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Insulin Resistance
- Being tested
- assessment of biomarkers of insulin resistance
- Keywords
- INSULIN RESISTANCE
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessment of biomarkers of insulin resistanceDiagnostic test
blood and urine sample collection for assays of BCAAs
| Study group | Role | What they receive |
|---|---|---|
| HEALTHY SUBJECTS | Experimental | SUBJECTS WITH BMI<27 and HOMA<4 Receives: Diagnostic Test: assessment of biomarkers of insulin resistance |
| OVERWEIGHT NON INSULINRESISTANT PATIENTS | Experimental | SUBJECTS WITH BMI>27 and HOMA<4 Receives: Diagnostic Test: assessment of biomarkers of insulin resistance |
| OVERWEIGHT INSULINRESISTANT PATIENTS | Experimental | SUBJECTS WITH BMI>27 and HOMA>4 Receives: Diagnostic Test: assessment of biomarkers of insulin resistance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between urinary levels of BCAAs and HOMA index
Identification of urinary BCAAs as markers of insulin resistance
Measured: through study completion, an average of two years and a half
Secondary outcomes (3)
Correlation between blood and urine BCAAs levels
Validation of urinary BCAAs as biomarkers of insulin resistance
Measured: 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
Measured by enzymatic method (artificial vesicles) and classic method (standard LC-MS/MS)
Measured: 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
Measured by enzymatic method (artificial vesicles) and HOMA index
Measured: through study completion, an average of two years and a half
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start16 Sep 2019
- Primary completion30 Sep 2023
- Study completion29 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Cohort of subjects with/without overweight and with/without insulin resistance
- Masking
- None (open label)
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France, Sys2Diag, Mixt laboratory CNRS/Alcediag, Montpellier
- Responsible party
- Sponsor
- Investigators
- EMILIE BARDE, Study director, UH Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04010903
- Sponsor's protocol ID
- 19_0077
- Acronym
- BIOMUIR
- Status last verified
- Oct 2024
- First submitted
- 2 Jul 2019
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Urinary Biomarkers for the Diagnosis of Insulin Resistance
- ClinicalTrials.gov ID
- NCT04010903
- Acronym / sponsor ID
- BIOMUIR / 19_0077
- Conditions
- Insulin Resistance
- Keywords
- INSULIN RESISTANCE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France, Sys2Diag, Mixt laboratory CNRS/Alcediag, Montpellier
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 29 Jul 2024 (actual)
- First posted
- 8 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Cohort of subjects with/without overweight and with/without insulin resistance
| Arm | Type | Receives |
|---|---|---|
| HEALTHY SUBJECTS | Experimental | Diagnostic Test: assessment of biomarkers of insulin resistanceSUBJECTS WITH BMI<27 and HOMA<4 |
| OVERWEIGHT NON INSULINRESISTANT PATIENTS | Experimental | Diagnostic Test: assessment of biomarkers of insulin resistanceSUBJECTS WITH BMI>27 and HOMA<4 |
| OVERWEIGHT INSULINRESISTANT PATIENTS | Experimental | Diagnostic Test: assessment of biomarkers of insulin resistanceSUBJECTS WITH BMI>27 and HOMA>4 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- no diabetes
- according to studied subpopulations: BMI<27 and HOMA <4, BMI>27 and HOMA>4, BMI>27 and HOMA<4
Key exclusion criteria (3 listed)
- pregnancy or lactation
- active or suspected chronic infection
- treatment affecting insulin sensitivity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| assessment of biomarkers of insulin resistanceblood and urine sample collection for assays of BCAAs | Diagnostic test | HEALTHY SUBJECTS, OVERWEIGHT INSULINRESISTANT PATIENTS, OVERWEIGHT NON INSULINRESISTANT PATIENTS |
Primary outcome
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
3 secondary outcomes
Correlation between blood and urine BCAAs levels
Time frame: 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
Time frame: 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
Time frame: through study completion, an average of two years and a half
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Insulin Resistance
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Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
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Effects of Meal Macronutrients on Postprandial Lipids
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Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
EMILIE BARDE study director
UH Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing assessment of biomarkers of insulin resistance in people with Insulin Resistance, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between urinary levels of BCAAs and HOMA index (time frame: through study completion, an average of two years and a half). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2024.