Status:
RECRUITING
BASE-DIET: a Study on Nutritional Intervention in Patients With Graves' Disease
Lead Sponsor:
Istituti Clinici Scientifici Maugeri SpA
Conditions:
Graves Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to determine whether a structured dietary-nutritional intervention can prevent excessive weight regain and improve body composition and lifestyle habits in adults re...
Detailed Description
What is the BASE-DIET Study? The BASE-DIET study is a clinical trial looking at how a healthy diet and lifestyle program can help people newly diagnosed with Graves' disease (an autoimmune thyroid con...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Diagnosis of Graves' disease in an endocrinology setting based on the presence of thyrotoxicosis and positive TRAb antibodies.
- Diagnosis of Graves' disease within 1 month prior to randomization.
- BMI \> 16 kg/m² and \< 35 kg/m² at the time of the first visit for Graves' disease.
- Age \> 18 years.
- Ability to commit to the duration of the study.
- Ability to provide informed consent and willingness to participate in the study.
- Exclusion Criteria
- Relapse of Graves' disease or thyrotoxicosis not related to Graves' disease.
- Any serious cardiovascular or renal event in the last 6 months.
- Current pregnancy, breastfeeding, or planning pregnancy during the study period.
- Any condition potentially leading to fluid overload such as heart failure (NYHA class \> I) or liver cirrhosis.
- Previously diagnosed significant psychiatric disorder (e.g., schizophrenia, post-traumatic stress disorder, obsessive-compulsive disorder).
- Active eating disorder.
- Uncontrolled depression.
- Uncontrolled epilepsy.
- Known cause of malabsorption (including uncontrolled celiac disease, lactose intolerance, or inflammatory bowel disease).
- Ongoing therapy with weight-modifying medications (e.g., GLP-1 analogs, metformin).
- Estimated BMI before disease onset \< 18 kg/m². This parameter will be calculated based on the "estimated pre-disease body weight" as reported by the patient.
Exclusion
Key Trial Info
Start Date :
January 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT06921304
Start Date
January 8 2024
End Date
June 30 2026
Last Update
April 13 2025
Active Locations (1)
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1
Istituti Clinici Maugeri IRCCS
Pavia, PV, Italy, 27100