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Dietary intervention aims to tame weight regain in Graves' patients

NCT ID NCT06921304

Disease control Sponsor: Istituti Clinici Scientifici Maugeri SpA Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a personalized low-calorie Mediterranean-style diet, combined with lifestyle coaching, can prevent people newly diagnosed with Graves' disease from regaining too much weight after their thyroid levels normalize. Fifty-four adults will be randomly assigned to either the diet program or standard care, and followed for a year. The goal is to see if the diet helps maintain a healthy weight and improves body composition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Intensive Lifestyle Intervention (personalized low-energy Mediterranean-style diet and lifestyle counseling)
What this could lead to
If it works, this could show that structured dietary support helps people with Graves' disease avoid unhealthy weight gain while on standard medication.
What could go wrong
This is a small early-stage trial (54 people) testing a behavioral change, not a drug. Results may not apply to everyone, and sticking to the diet long-term can be challenging.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 54 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Body Weight Graves disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Graves disease

Contacts and locations

Locations

  • Istituti Clinici Maugeri IRCCS

    Pavia, PV, 27100, Italy

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