CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 128 enrolled
Drug / intervention
Bariatric Surgeryprocedure
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03889132
NCT03889132N/ACompleted

Integrated Analysis of the Interactions Between Glycemia and Microbiota Composition, and Their Impact on Brain Iron Deposition and Cognition in Subjects With Obesity

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta·observational·Posted Mar 26, 2019·Updated Mar 31, 2026

In Brief

An observational study evaluating Bariatric Surgery for Obesity. Completed, enrolled 128 participants across 1 site.

Detailed Summary

The accumulation of iron is known to affect the functions of the liver, adipose tissue and muscle. The brain is a well-known place of iron deposition, which is associated with cognitive parameters of subjects with obesity. The hypothesis is that certain parameters related to glucose metabolism (glycemic variability, the circulating concentration of AGE receptor agonists, pentosidine and HbA1c) are associated with cognitive function, brain iron content and gut microbiota composition in subjects with obesity. The study includes both a cross-sectional (comparison of subjects with and without obesity) and a longitudinal design (evaluation one year after weight loss induced by bariatric surgery or by diet in patient with obesity) to evaluate the associations between continuous glucose monitoring, brain iron content (by magnetic resonance), cognitive function (by means of cognitive tests), physical activity (measured by activity and sleep tracker device) and the composition of the microbiota, evaluated by metagenomics.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMar 26, 2019
Enrollment StartMar 5, 2019
Primary CompletionJul 31, 2022
Study CompletionMay 31, 2025
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 7.3 years ago

Interventions

Bariatric Surgeryprocedure

Subjects with obesity (N=60) will be undertaken a hypocaloric diet and a periodic follow up, also 30 of them will undergo bariatric surgery