Glucose, Brain and Microbiota
NCT03889132, Completed, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Glucose, Brain and Microbiota | ClinicalTrials.gov |
| NCT number | NCT03889132 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Enrollment | 128 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta | ClinicalTrials.gov |
| Conditions | Obesity | ClinicalTrials.gov |
| Interventions | Bariatric Surgery | ClinicalTrials.gov |
| First posted | 2019-03-26 | ClinicalTrials.gov |
| Last updated | 2026-03-31 | ClinicalTrials.gov |
Registered outcomes 52
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Concentration of advanced glycation end products (AGE) receptor agonists. | 30 months | Enzyme-linked immunosorbent assay (ELISA). | ClinicalTrials.gov |
| Primary | Glycemic variability. | 30 months | Mean and standard deviation of glucose measures in mg/dL using a continuous glucose monitoring during 10 days. | ClinicalTrials.gov |
| Primary | The percentage of time in glucose target range (glucose level 100mg/dl-125mg/dl) | 30 months | ClinicalTrials.gov | |
| Primary | The glycaemic risk measured with low blood glucose index (LBGI) | 30 months | Low blood glucose index (LBGI) is a parameter that quantifies the risk of glycaemic excursions in non-negative numbers. | ClinicalTrials.gov |
| Primary | The glycaemic risk measured with high blood glucose index (HBGI) | 30 months | High blood glucose index (HBGI) is a parameter that quantifies the risk of glycaemic excursions in non-negative numbers. | ClinicalTrials.gov |
| Primary | The glycaemic variability measured with mean amplitude of glycaemic excursions (MAGE) | 30 months | measured in mg/dl | ClinicalTrials.gov |
| Primary | Minutes light sleep | 30 months | Mean and standard deviation of minutes light sleep measures by activity and sleep tracker device. | ClinicalTrials.gov |
| Primary | Minutes deep sleep | 30 months | Mean and standard deviation of minutes deep sleep measures by activity and sleep tracker device. | ClinicalTrials.gov |
| Primary | Minutes rapid eye movement (REM) | 30 months | Mean and standard deviation of minutes REM measures by activity and sleep tracker device. | ClinicalTrials.gov |
| Secondary | Effect on brain structure. | 30 months | Brain structure will be assessed using magnetic resonance imaging. | ClinicalTrials.gov |
| Secondary | Effect on gut microbiota. | 30 months | Gut 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 months | Subjects with obesity will be undertaken conventional treatment or bariatric surgery for weight loss; controls will not undergo any additional measure. | ClinicalTrials.gov |
| Secondary | Cognitive impairment | 30 months | It will be measured by Mini-Examen Cognoscitivo (MEC). Minimum/maximum scale values (0-30), where ≥ 27 is a normal score. | ClinicalTrials.gov |
| Secondary | Audioverbal memory | 30 months | It will be measured by California Verbal Learning Test (CVLT). Minimum/maximum scale values (0-16), where 16 is a better audioverbal memory. | ClinicalTrials.gov |
| Secondary | Visual memory | 30 months | It will be measured by Rey-Osterrieth Complex Figure. Minimum/maximum scale values (0-36), where 36 is a better visual memory | ClinicalTrials.gov |
| Secondary | Depressive symptomatology | 30 months | It will be measured by Patient Health Questionnaire-9 (PHQ-9). Minimum/maximum scale values (0-27), where ≥ 20 is severe depression. | ClinicalTrials.gov |
| Secondary | Impulsivity | 30 months | It will be measured by Impulsive Behavior Scale (UPPS-P). The test evaluates: Negative urgency (tendency to act rashly under extreme negative emotions), Lack of Premeditation (tendency to act without thinking), Lack of Perseverance (inability to remain focused on a task) and Sensation Seeking (tendency to seek out novel and thrilling experiences). All items are rated on a four point scale from 1 (strongly agree) to 4 (strongly disagree). | ClinicalTrials.gov |
| Secondary | Food Addiction | 30 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 |
| Secondary | Behavioral inhibition | 30 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 |
| Secondary | Behavioral activation | 30 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.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 28
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 8080980 | BACKGROUND | PubMed |
| 9580307 | BACKGROUND | PubMed |
| 12145144 | BACKGROUND | PubMed |
| 12433763 | BACKGROUND | PubMed |
| 16443885 | BACKGROUND | PubMed |
| 17977953 | BACKGROUND | PubMed |
| 21677749 | BACKGROUND | PubMed |
| 22634723 | BACKGROUND | PubMed |
| 24731656 | BACKGROUND | PubMed |
| 25125507 | BACKGROUND | PubMed |
| 25163604 | BACKGROUND | PubMed |
| 25217888 | BACKGROUND | PubMed |
| 25459912 | BACKGROUND | PubMed |
| 25948725 | BACKGROUND | PubMed |
| 26590418 | BACKGROUND | PubMed |
| 26765579 | BACKGROUND | PubMed |
| 26813526 | BACKGROUND | PubMed |
| 27409811 | BACKGROUND | PubMed |
| 27745814 | BACKGROUND | PubMed |
| 27842994 | BACKGROUND | PubMed |
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 6
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Complex Figure Copy and Recall | Secondary outcome | ConductCognition |
| Picture Naming Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
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)