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Glucose, Brain and Microbiota (IRONMEt+CGM)

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ClinicalTrials.gov Identifier: NCT03889132
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
José Manuel Fernández-Real, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Brief 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) and the composition of the microbiota, evaluated by metagenomics.


Condition or disease Intervention/treatment
Obesity Procedure: Bariatric Surgery

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Integrated Analysis of the Interactions Between Glycemia and Microbiota Composition, and Their Impact on Brain Iron Deposition and Cognition in Subjects With Obesity
Actual Study Start Date : March 5, 2019
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Premenopausal women with obesity Procedure: Bariatric Surgery
Subjects with obesity (N=60) will be undertaken a hypocaloric diet and a periodic follow up, also 30 of them will undergo bariatric surgery

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

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

Premenopausal women without obesity
Postmenopausal women without obesity
Men without obesity



Primary Outcome Measures :
  1. Concentration of advanced glycation end products (AGE) receptor agonists. [ Time Frame: 30 months ]
    Enzyme-linked immunosorbent assay (ELISA).

  2. Glycemic variability. [ Time Frame: 30 months ]
    Mean and standard deviation of glucose measures in mg/dL using a continuous glucose monitoring during 10 days.


Secondary Outcome Measures :
  1. Effect on memory function [ Time Frame: 30 months ]
    California Verbal Learning Test (CVLT): Measures verbal memory (Total score of the 12 trials); a higher score reflects a better memory function.

  2. Effect on brain structure. [ Time Frame: 30 months ]
    Brain structure will be assessed using magnetic resonance imaging.

  3. Effect on gut microbiota. [ Time Frame: 30 months ]
    Gut microbiota will be analysed by metagenomics and metabolomics.

  4. 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. [ Time Frame: 30 months ]
    Subjects with obesity will be undertaken conventional treatment or bariatric surgery for weight loss; controls will not undergo any additional measure.



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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with obesity, without known type 2 diabetes, previously scheduled at the Service of Endocrinology, Diabetes and Nutrition (UDEN) of the Hospital "Dr. Josep Trueta" of Girona (Spain) will be recruited and studied.

Subjects without obesity will also be recruited through a public announcement.

Criteria

Inclusion Criteria:

  1. Caucasian men and women aged 30-65 years.
  2. Informed consent for participation in the study.

Exclusion Criteria:

  1. Serious systemic disease unrelated to obesity such as cancer, severe kidney, or liver disease, known type 1 or type 2 diabetes.
  2. 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.
  3. Pregnancy and lactation.
  4. Patients with severe disorders of eating behaviour.
  5. Persons whose liberty is under legal or administrative requirement.
  6. Clinical symptoms and signs of infection in the previous month.
  7. Antibiotic, antifungal or antiviral treatment in the previous 3 months.
  8. Anti-inflammatory chronic treatment with steroidal and/or non-steroidal anti-inflammatory drugs.
  9. Major psychiatric antecedents.
  10. Excessive alcohol intake, either acute or chronic (alcohol intake greater than 40 g a day (women) or 80 g/day (men)) or drugs abuse.
  11. Serum liver enzymes (AST, ALT) activity over twice the upper limit of normal.
  12. History of disturbances in iron balance (e.g., genetic hemochromatosis, hemosiderosis from any cause, atransferrinemia, paroxysmal nocturnal hemoglobinuria).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03889132


Contacts
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Contact: José Manuel Fernández-Real, M.D., Ph.D. +34 972 94 02 00 jmfreal@idibgi.org
Contact: María Arnoriaga Rodríguez, M.D. +34 972 94 02 00 ext 2325 marnoriaga@idibgi.org

Locations
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Spain
Institut d'Investigació Biomèdica de Girona (IDIBGI) Recruiting
Girona, Spain, 17007
Contact: Yenny Leal    0034 972940200 ext 2325    yleal@idibgi.org   
Contact: Marzena Wos    0034 972940200 ext 2325    mawos@idibgi.org   
Sponsors and Collaborators
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Investigators
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Principal Investigator: José Manuel Fernández-Real, M.D., Ph.D. Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Publications:

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Responsible Party: José Manuel Fernández-Real, Principal investigator, clinical professor, section chief of Endocrinology and Nutrition Department of Josep Trueta University Hospital, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
ClinicalTrials.gov Identifier: NCT03889132     History of Changes
Other Study ID Numbers: PI18/01022
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by José Manuel Fernández-Real, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta:
Obesity
Continous Glucose Monitoring
Cognition
Brain Iron content
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms