Nutritional intervention for managing weight in Graves' disease patients
BASE-DIET: a Randomized Clinical Trial to Examine the Impact of a Dietary-nutritional Intervention on Body Weight Recovery, Metabolic Parameters, and Body Composition in Patients With a New Diagnosis of Graves' Disease
This study is testing whether a special diet and lifestyle program can help adults recently diagnosed with Graves' disease manage their weight better than just regular medical advice.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA Academic / other |
| Locations | 1 site (Pavia, PV) |
| Trial ID | NCT06921304 on ClinicalTrials.gov |
What this trial studies
The BASE-DIET study investigates the effects of a structured dietary and lifestyle intervention on adults recently diagnosed with Graves' disease. It aims to determine if this intervention can prevent excessive weight regain after treatment and improve body composition and lifestyle habits. Participants will be randomized to receive either an Intensive Lifestyle Intervention (ILI) with personalized diet and counseling or Usual Medical Care (UMC) with general advice. The study focuses on patients who have been diagnosed within the last month and are willing to commit to a year-long program.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old, recently diagnosed with Graves' disease, and have a BMI between 16 and 35.
Not a fit: Patients who are pregnant, have certain serious health conditions, or are already taking weight-related medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could help patients maintain a healthy weight and improve their overall health after treatment for Graves' disease.
How similar studies have performed: Previous research has indicated that dietary interventions can positively impact weight management in similar patient populations, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Pavia, PV
- Istituti Clinici Maugeri IRCCS — Pavia, Pv, Italy (Recruiting)
Study contacts
- Study coordinator: Laura Croce, MD PhD
- Email: laura.croce@icsmaugeri.it
- Phone: 0039 3295699821
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.