Logo 1 Logo 2

Clinical Trial Details

Trial ID: L2857
Source ID: NCT04841668
Associated Drug: Metformin
Title: Gut-Brain-axis: Targets for Improvement of Cognition in the Elderly
Acronym: SmartAge
Status: RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Metformin
Outcome Measures: Primary: Gut microbiota composition., It will be identified in the stool by cultures and DNA and mRNA expression after metformin treatment., 12 months|Cognitive impairment, It will be measured by Mini-Examen Cognoscitivo (MEC)., 12 months|Audioverbal memory, It will be measured by Test aprendizaje verbal-TAVEC., 12 months|Visual memory, It will be measured by Rey-Osterrieth Complex Figure., 12 months|Depressive symptomatology, It will be measured by Patient Health Questionnaire-9 (PHQ-9)., 12 months|Impulsivity, It will be measured by UPPS Impulsive Behavior Scale., 12 months|Food Addiction, It will be measured by Yale Food Addiction Scale., 12 months|Behavioral inhibition, It will be measured by Sensitivity to Punishment and Sensitivity to Reward (SPSRQ)., 12 months|Behavioral activation, It will be measured by Sensitivity to Punishment and Sensitivity to Reward (SPSRQ)., 12 months|Visoconstructive function, It will be measured by Rey-Osterrieth Complex Figure., 12 months|Visuospatial perception, It will be measured by Judgment Line Orientation., 12 months|Naming, It will be measured by Boston Naming Test., 12 months|Selective and alternating attention, It will be measured by Trail making test (Part A y B)., 12 months|Attention and working memory, It will be measured by the Wechsler Adult Intelligence Scales, Fourth Edition (WAIS-IV)., 12 months|Inhibition, It will be measured by Stroop Color-Word Test., 12 months|Phonemic verbal fluency, It will be measured by PMR, 12 months|Semantic verbal fluency, It will be measured by Animals, 12 months | Secondary: The percentage of time in glucose target range (glucose level 70mg/dl-180mg/dl), 12 months|Effect on gut microbiota, Gut microbiota will be analysed by metagenomics and metabolomics., 12 months|The percentage of time in glucose range (glucose level below 100 mg/dl), 12 months|The percentage of time in glucose range (glucose level between 100-125 mg/dl), 12 months|The percentage of time in glucose range (glucose level between 126-139 mg/dl), 12 months|The percentage of time in glucose range (glucose level between 140-199 mg/dl), 12 months | Other: Integrity of the brain gray matter, It will be assessed using magnetic resonance imaging (T1-weighted), 12 months|Integrity of the white matter tracts, It will be assessed using magnetic resonance imaging with diffusion tensor imaging (DTI), 12 months|Brain iron accumulation, It will be assessed using magnetic resonance imaging using (R2\*), 12 months|Resting-state functional brain sequences, It will be assessed using magnetic resonance imaging (T2\*-weighted echo-planar imaging), 12 months|Insulin resistance, It will be measured by HOMA, 12 months|Markers of chronic inflammation: C-reactive protein, IL-6, adiponectin and soluble, tumor necrosis factor-α receptor fractions., Enzyme-linked immunosorbent assay (ELISA) and quantitative polymerase chain reaction (qPCR), 12 months|Glycosylated hemoglobin (HbA1c) value, Glycosylated hemoglobin (HbA1c) in % or mmol/mol, 12 months|The percentage of time in hyperglycaemia (glucose level above 180 mg/dl), 12 months|The percentage of time in hypoglycaemia (glucose level below 70 mg/dl), 12 months|The glycaemic risk measured with low blood glucose index (LBGI), Low blood glucose index (LBGI) is a parameter that quantifies the risk of glycaemic excursions in non-negative numbers., 12 months|The glycaemic risk measured with high blood glucose index (HBGI), High blood glucose index (HBGI) is a parameter that quantifies the risk of glycaemic excursions in non-negative numbers., 12 months|The glycaemic variability measured with mean amplitude of glycaemic excursions (MAGE), measured in mg/dl, 12 months|Burned calories, Mean and standard deviation of burned calories measures by activity and sleep tracker device., 12 months|Steps, Mean and standard deviation of steps measures by activity and sleep tracker device., 12 months|Distance, Mean and standard deviation of distance measures by activity and sleep tracker device., 12 months|Plants, Mean and standard deviation of plants measures by activity and sleep tracker device., 12 months|Minutes null activity, Mean and standard deviation of minutes null activity measures by activity and sleep tracker device., 12 months|Minutes slight activity, Mean and standard deviation of minutes slight activity measures by activity and sleep tracker device., 12 months|Minutes mean activity, Mean and standard deviation of minutes mean activity measures by activity and sleep tracker device., 12 months|Minutes high activity, Mean and standard deviation of minutes high activity measures by activity and sleep tracker device., 12 months|Calories consumption, Mean and standard deviation of calories measures by activity and sleep tracker device., 12 months|Minutes asleep, Mean and standard deviation of minutes asleep measures by activity and sleep tracker device., 12 months|Minutes awake, Mean and standard deviation of minutes awake measures by activity and sleep tracker device., 12 months|Bed time, Mean and standard deviation of bed time measures by activity and sleep tracker device., 12 months|Minutes light sleep, Mean and standard deviation of minutes light sleep measures by activity and sleep tracker device., 12 months|Minutes deep sleep, Mean and standard deviation of minutes deep sleep measures by activity and sleep tracker device., 12 months|Minutes rapid eye movement (REM), Mean and standard deviation of minutes REM measures by activity and sleep tracker device., 12 months|Number time awake, Mean and standard deviation of number time awake measures by activity and sleep tracker device., 12 months
Sponsor/Collaborators: Sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Gender: ALL
Age: OLDER_ADULT
Phases:
Enrollment: 136
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2021-04-10
Completion Date: 2026-02-28
Results First Posted:
Last Update Posted: 2024-03-08
Locations: Institut d'Investigació Biomèdica de Girona (IDIBGI), Girona, 17007, Spain
URL: https://clinicaltrials.gov/show/NCT04841668