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Inter-relationships Among Glucose, Brain, Gut Microbiota and MicroRNAs (IRONmiRNA).

NCT05345106, Active not recruiting, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Trial 9

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

FieldValueSource
TitleInter-relationships Among Glucose, Brain, Gut Microbiota and MicroRNAs (IRONmiRNA).ClinicalTrials.gov
NCT numberNCT05345106ClinicalTrials.gov
StatusActive not recruitingClinicalTrials.gov
Enrollment138 participants, actualClinicalTrials.gov
Lead sponsorInstitut d'Investigació Biomèdica de Girona Dr. Josep TruetaClinicalTrials.gov
ConditionsObesityClinicalTrials.gov
InterventionsBariatric SurgeryClinicalTrials.gov
First posted2022-04-25ClinicalTrials.gov
Last updated2026-03-31ClinicalTrials.gov

Registered outcomes 52

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescriptionSource
PrimaryConcentration of advanced glycation end products (AGE) receptor agonists.30 monthsEnzyme-linked immunosorbent assay (ELISA).ClinicalTrials.gov
PrimaryGlycemic variability.30 monthsMean and standard deviation of glucose measures in mg/dL using a continuous glucose monitoring during 10 days.ClinicalTrials.gov
PrimaryThe percentage of time in glucose target range (glucose level 100mg/dl-125mg/dl)30 monthsClinicalTrials.gov
PrimaryThe glycaemic risk measured with low blood glucose index (LBGI)30 monthsLow blood glucose index (LBGI) is a parameter that quantifies the risk of glycaemicClinicalTrials.gov
PrimaryThe glycaemic risk measured with high blood glucose index (HBGI)30 monthsHigh blood glucose index (HBGI) is a parameter that quantifies the risk of glycaemicClinicalTrials.gov
PrimaryThe glycaemic variability measured with mean amplitude of glycaemic excursions (MAGE)30 monthsmeasured in mg/dlClinicalTrials.gov
PrimaryMinutes light sleep30 monthsMean and standard deviation of minutes light sleep measures by activity and sleep tracker device.ClinicalTrials.gov
PrimaryMinutes deep sleep30 monthsMean and standard deviation of minutes deep sleep measures by activity and sleep tracker device.ClinicalTrials.gov
PrimaryMinutes rapid eye movement (REM)30 monthsMean and standard deviation of minutes REM measures by activity and sleep tracker device.ClinicalTrials.gov
SecondaryEffect on brain structure.30 monthsBrain structure will be assessed using magnetic resonance imaging.ClinicalTrials.gov
SecondaryEffect on gut microbiota.30 monthsGut microbiota will be analysed by metagenomics and metabolomics.ClinicalTrials.gov
Secondary
Changes from baseline in circulating concentration of AGE receptor agonists and glycemic variability one year of follow-up after weight loss in association with changes in brain structure and gut microbiota.
30 monthsSubjects with obesity will be undertaken conventional treatment or bariatric surgery for weight loss; controls will not undergo any additional measure.ClinicalTrials.gov
SecondaryAnxiety state30 monthsIt will be measured by State-Trate Anxiety Inventory (STAI).ClinicalTrials.gov
SecondaryAudioverbal memory30 monthsIt will be measured by California Verbal Learning Test (CVLT). Minimum/maximum scale values (0-16), where 16 is a better audioverbal memory.ClinicalTrials.gov
SecondaryVisual memory30 monthsIt will be measured by Rey-Osterrieth Complex Figure. Minimum/maximum scale values (0-36), where 36 is a better visual memoryClinicalTrials.gov
SecondaryDepressive symptomatology30 monthsIt will be measured by Patient Health Questionnaire-9 (PHQ-9). Minimum/maximum scale values (0-27), where ≥ 20 is severe depression.ClinicalTrials.gov
SecondaryImpulsivity30 monthsIt will be measured by Impulsive Behavior Scale (UPPS-P). The test evaluates: NegativeClinicalTrials.gov
SecondaryFood Addiction30 months
It will be measured by Yale Food Addiction Scale.It is a symptom score from 0-11, based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria, for substance dependence. Food addiction is diagnosed if ≥3 symptoms are reported.
ClinicalTrials.gov
SecondaryBehavioral inhibition30 months
It will be measured by Sensitivity to Punishment and Sensitivity to Reward (SPSRQ). The scale of sensitivity to punishment is related to the behavioral inhibition system. It is made up of two subscales of 24 items each, where the higher the score, the greater the sensitivity to punishment.
ClinicalTrials.gov
SecondaryBehavioral activation30 months
It will be measured by Sensitivity to Punishment and Sensitivity to Reward (SPSRQ). The reward sensitivity scale is related to the behavioral activation system. It is made up of two subscales of 24 items each, where the higher the score, the greater the sensitivity to reward.
ClinicalTrials.gov

Outcomes 0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured asSource

Results by group 0

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnitsSource

Participant flow 0

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits countedSource

Adverse events 0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEventsSource

Adverse event totals 0

The totals the trial posted for each group.

TotalGroupAffectedAt riskSource

Papers 39

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
8080980BACKGROUNDPubMed
9580307BACKGROUNDPubMed
12145144BACKGROUNDPubMed
16443885BACKGROUNDPubMed
17629564BACKGROUNDPubMed
17977953BACKGROUNDPubMed
21677749BACKGROUNDPubMed
21976504BACKGROUNDPubMed
22925464BACKGROUNDPubMed
23345246BACKGROUNDPubMed
23396142BACKGROUNDPubMed
24478399BACKGROUNDPubMed
24731656BACKGROUNDPubMed
25125507BACKGROUNDPubMed
25163604BACKGROUNDPubMed
25217888BACKGROUNDPubMed
25948725BACKGROUNDPubMed
26438800BACKGROUNDPubMed
26494171BACKGROUNDPubMed
26764595BACKGROUNDPubMed

Grants 0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal yearsSource

Trial comparisons 0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource

Tests 5

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

TestNamed asSource
Complex Figure Copy and RecallSecondary outcomeConductCognition
Stroop Color-Word TestSecondary outcomeConductCognition
Trail Making Test ASecondary outcomeConductCognition
Verbal FluencySecondary outcomeConductCognition
Verbal LearningSecondary outcomeConductCognition

Source 5

FieldValueSource
Releasetrials-2026-11-12-0.4.0ClinicalTrials.gov
Release manifest SHA-2560f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4ClinicalTrials.gov
Registry capture2026-11-12ClinicalTrials.gov
Results copy, AACT2026-03-23ClinicalTrials.gov
NIH clinical studies file2026-11-13ClinicalTrials.gov

The same record as JSON

Release trials-2026-11-12-0.4.0

ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)