NCT03889132Completed
Glucose, Brain and Microbiota
Integrated Analysis of the Interactions Between Glycemia and Microbiota Composition, and Their Impact on Brain Iron Deposition and Cognition in Subjects With Obesity
Source: ClinicalTrials.gov · Last updated 31 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 128 (actual)
- First submitted
- 27 Feb 2019
- Start date
- Mar 2019
- Primary completion date
- Jul 2022
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
- Diseases
- Obesity
- NCT number
- NCT03889132
What you commit to
- Study type: Observational
- Participants enrolled: 128
- From Mar 2019 to the primary completion date, Jul 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Clinical symptoms and signs of infection in the previous month.
- Antibiotic, antifungal or antiviral treatment in the previous 3 months.
- Anti-inflammatory chronic treatment with steroidal and/or non-steroidal anti-inflammatory drugs.
- Excessive alcohol intake, either acute or chronic (alcohol intake greater than 40 g a day (women) or 80 g/day (men)) or drugs abuse.
Other illness
- Serious systemic disease unrelated to obesity such as cancer, severe kidney, or liver disease, known type 1 or type 2 diabetes.
- Systemic diseases with intrinsic inflammatory activity such as rheumatoid arthritis, Crohn's disease, asthma, chronic infection (e.g., HIV, active tuberculosis) or any type of infectious disease.
- Patients with severe disorders of eating behaviour.
- Major psychiatric antecedents.
- History of disturbances in iron balance (e.g., genetic hemochromatosis, hemosiderosis from any cause, atransferrinemia, paroxysmal nocturnal hemoglobinuria).
Lab values
- Serum liver enzymes (AST, ALT) activity over twice the upper limit of normal.
Other
- Pregnancy and lactation.
- Persons whose liberty is under legal or administrative requirement.
Who the study is looking for
- Men and women aged 30-65 years.
- Informed consent for participation in the study.
Age in the registry: 30 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut d'Investigació Biomèdica de Girona (IDIBGI) Coordinator of this site? Confirm its status | Girona | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.