Status:
RECRUITING
Gut-Brain-axis: Targets for Improvement of Cognition in the Elderly
Lead Sponsor:
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
65-80 years
Brief Summary
Cognitive disorders increase with age and in the presence of metabolic diseases such as Type 2 Diabetes Mellitus (T2DM). In addition, digestive disorders, changes in dietary pattern and decreased acti...
Detailed Description
Subjects and methods: Longitudinal study: Patients with T2DM previously scheduled at the Service of Endocrinology, Diabetes and Nutrition (UDEN) of the Hospital "Dr. Josep Trueta" of Girona (Spain) ...
Eligibility Criteria
Inclusion
- Group A
- Age between 55 and 80 years.
- Patients with recently diagnosed T2DM (last 6 months), according to the WHO classification.
- Patients in whom written informed consent has been obtained for participation in the study.
Exclusion
- HbA1c ≥ 9%
- Metformin treatment in the past 6 months
- Creatinine greater than 1.2 and glomerular filtration rate less than 40
- Serious systemic disease not related to obesity, including any type of cancer, severe kidney disease or liver disease, and known type 1 diabetes.
- Systemic diseases with intrinsic inflammatory activity such as rheumatoid arthritis, Crohn's disease, asthma, or chronic infection (e.g., HIV, active tuberculosis) or any type of infectious disease.
- Current treatment for malignant neoplasia, other than basal cell or squamous cell skin cancer.
- Class III or IV heart disease, known ischemic cardiovascular disease
- Kidney failure, history of kidney transplant, or current dialysis treatment
- Serum liver enzymes (GOT, GPT) above twice the upper limit of normal. Obvious signs or symptoms of liver disease, acute or chronic hepatitis.
- Chronic constipation (stool habit ≥ 7 days)
- Pregnancy or breastfeeding
- Treatments that affect glucose metabolism or the intestinal microbiota with biguanides, sulfonylurea secretagogues or non-sulfonylurea secretagogues, insulin sensitizers, insulin, thiazolidinediones, alpha glucosidase inhibitors, incretin mimetics, Dipeptidyl peptidase IV inhibitors, use of cathartics.
- Chronic anti-inflammatory treatment with steroidal drugs (during the previous 3 months).
- Symptoms and / or clinical signs of infection in the previous month.
- Antibiotic, antifungal or antiviral treatment active in the previous 3 months.
- Treatment with glucocorticoids chronic or during the 2 months prior to inclusion in the study.
- Treatment with a weight loss product during the previous two months
- Immunosuppressant treatment.
- Excessive alcohol consumption (alcohol intake greater than 40 g per day (women) or 80 g / day (men)) either acute or chronic, or drug use. History of drug or alcohol abuse.
- Patients with severe eating disorders
- History of alterations in iron balance (known chronic hemoglobinopathies or anemia, genetic hemochromatosis, hemosiderosis from any cause, atransferrinemia, paroxysmal nocturnal hemoglobinuria).
- Important psychiatric history.
- Participation in any other study.
- People whose freedom is under legal or administrative requirement.
- Group B
- Inclusion Criteria:
- Age between 65 and 80 years.
- Patients with long-term T2DM according to the WHO classification
- Patients in whom written informed consent has been obtained for participation in the study.
Key Trial Info
Start Date :
April 10 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT04841668
Start Date
April 10 2021
End Date
February 1 2026
Last Update
December 12 2025
Active Locations (1)
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1
Institut d'Investigació Biomèdica de Girona (IDIBGI)
Girona, Girona, Spain, 17007