Graves DiseaseBASEDIETNCT06921304
BASE-DIET: a Study on Nutritional Intervention in Patients With Graves' Disease
A study testing Intensive Lifestyle Intervention in people with Graves Disease, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
Trial 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 recently diagnosed with Graves' disease (Basedow's disease). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graves Disease
- What is being tested?
- Intensive Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteItaly
- Study dates
- 8 Jan 2024to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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 recently diagnosed with Graves' disease (Basedow's disease).
The main questions it aims to answer are:
Read more
- Can a dietary intervention prevent patients from regaining more than 1 kg above their pre-disease body weight after restoring euthyroidism?
- Does the intervention lead to improvements in body composition, dietary habits, and adherence to the Mediterranean diet? Researchers will compare patients receiving an Intensive Lifestyle Intervention (ILI) including a personalized diet and lifestyle counseling to patients receiving Usual Medical Care (UMC) with general lifestyle advice to see if the dietary intervention results in less weight regain and better metabolic and anthropometric outcomes.
Participants will:
- Receive antithyroid medication as standard medical care.
- Be randomized into either the intervention group (ILI) or control group (UMC).
If in the ILI group, participants will:
- Receive an individual nutritional consultation within 1 week of enrollment.
- Follow a personalized Mediterranean-style low-energy diet.
- Attend follow-up visits at 3, 6, 9, and 12 months for:
- Dietary adherence and lifestyle assessments.
- Anthropometric measurements (weight, BMI, waist/hip circumference).
- Bioimpedance analysis (at 6 and 12 months) for body composition.
- Dietary intake logs and adherence assessments (3-day food diary).
If in the UMC group, participants will:
- Receive routine clinical management for Graves' disease.
- Complete basic dietary and lifestyle questionnaires at baseline and 12 months.
- Undergo anthropometric measurements and bioimpedance at T0 and at the end of study.
This study aims to provide evidence on the role of nutritional support in managing weight and metabolic risks in patients undergoing treatment for Graves' disease.
Read the 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 condition) manage weight changes and improve their health during and after treatment.
Graves' disease often causes weight loss when it's active. But after treatment, many people gain back the weight-and sometimes even more than they had before. This study wants to find out if a personalized diet and lifestyle approach can help prevent that excessive weight gain and promote better health outcomes.
Why is this study important? When thyroid function is brought back to normal (called "euthyroidism"), many patients regain weight. In fact, up to 80% of patients report weight gain after treatment, which can impact self-esteem and health.
Some research shows this weight gain might go beyond what people weighed before getting sick. This study wants to see whether a structured diet and lifestyle program can make a positive difference compared to the usual medical care alone.
Who is participating in the study?
Adults newly diagnosed with Graves' disease at endocrinology clinics in Italy are invited to take part. Participants must:
- Be over 18 years old
- Have been diagnosed within the previous month
- Have a BMI between 16 and 35
- Be willing to commit to a 1-year program They cannot participate if they are pregnant, have certain health conditions, or are already taking weight-related medications.
How is the study organized?
The study randomly assigns people to one of two groups:
- Intervention Group (ILI) - This group receives:
- Personalized nutrition counseling by a licensed dietitian
- A Mediterranean-style, low-calorie diet plan
- Support on physical activity and lifestyle
- Follow-up appointments at 3, 6, 9, and 12 months
- Control Group (UMC) - This group receives:
- Standard medical care for Graves' disease
- General lifestyle and diet tips (no personalized plan)
- Two check-ins at the beginning and end of the 12-month period What is being measured? The main goal (primary outcome) is to see if people in the intervention group are less likely to gain more than 1 kg over their pre-disease weight after 12 months.
Secondary goals include:
- Changes in Body Mass Index (BMI)
- Body composition (muscle vs. fat mass)
- Waist-to-hip ratio
- Adherence to a Mediterranean diet
- Improved eating habits and quality of life What happens during follow-up?
At each check-up, researchers will:
- Measure weight, height, waist and hip size
- Use a body composition test (bioimpedance analysis)
- Review a 3-day food diary
- Ask about physical activity and lifestyle changes
- Check how closely participants follow the prescribed diet Only the intervention group receives repeated, in-depth dietary coaching. How long does the study last? The full study duration for each participant is 12 months, with an extended follow-up period for data collection.
How many people are in the study? The study plans to enroll 60 people (30 in each group), which accounts for a small number of possible dropouts.
Is the study safe and ethical?
Yes. It follows strict ethical guidelines:
- All participants give written informed consent
- Privacy is fully protected
- Participation is voluntary, and people can leave at any time There are no outside sponsors-it's a non-profit, academic study led by IRCCS Maugeri in Pavia, Italy.
What will happen with the results?
Results will be:
- Published in scientific journals
- Shared at medical conferences
- Made available to the public The goal is to better understand how diet can help people with Graves' disease manage their weight and improve their recovery.
- Conditions
- Graves Disease
- Being tested
- Intensive Lifestyle Intervention
- Keywords
- graves disease, diet, body weight, PREDIMED
- Medical subject headings
- Graves Disease, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Lifestyle InterventionBehavioural
ILI combines a low-calorie dietary approach with improved lifestyle and physical activity, in addition to usual medical care. Behavioral support for lifestyle intervention will also be provided.
| Study group | Role | What they receive |
|---|---|---|
| Usual Medical Care (UMC) | No intervention | Usual Medical Care for Graves' Disease and general lifestyle advice |
| Intensive Lifestyle Intervention (ILI) | Experimental | Usual Medical Care for Graves' Disease plus a personalized diet and lifestyle counseling Receives: Behavioral: Intensive Lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight increase vs pre-disease weight
Weight gain compared to the estimated pre-disease body weight. A 'failure' will be defined as a weight gain of more than 1 kg above the patient-reported estimated pre-disease body weight, assessed 12 months after the start of the study. Body weight and height will be combined to report BMI in kg/m^2
Measured: Through study completion, an average of 1 year
Secondary outcomes (4)
BMI changes
Direct comparison of the BMI achieved at the end of the study period between the two groups, with subsequent calculation of weight gain relative to baseline weight. Weight change will be assessed as the difference between the weight measured in kilograms at the end of the study and that measured at the beginning, expressed as a percentage of the initial weight. Body weight and height will be combined to report BMI in kg/m^2
Measured: Through study completion, an average of 1 year
Adherence to the Mediterranean Diet
A successful outcome will be defined as an improvement in adherence scores based on the PREDIMED questionnaire.
Measured: Through study completion, an average of 1 year
Changes in body composition parameters
This will be defined as the normalization of abnormal values of fat mass percentage, lean mass, or total body water detected at baseline (T0). For participants with optimal values at T0, success will be defined as maintaining optimal parameters; worsening of these parameters will be considered a failure.
Measured: Through study completion, an average of 1 year
Changes in waist-to-hip ratio
A successful outcome will be defined as an improvement in waist-to-hip ratio in participants with abnormal values at baseline. For those with optimal values at T0, maintaining optimal parameters will be considered a success, while deterioration will be considered a failure.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start8 Jan 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Graves DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Croce, Istituti Clinici Scientifici Maugeri SpA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921304
- Sponsor's protocol ID
- BASE-DIET 01
- Acronym
- BASEDIET
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2025
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Croce L, Pallavicini C, Busca N, Cali B, Bellastella G, Coperchini F, Magri F, Chiovato L, Cena H, Rotondi M. Pre-surgery dietician counseling can prevent post-thyroidectomy body weight gain: results of an intervention trial. Endocrine. 2023 Aug;81(2):246-251. doi: 10.1007/s12020-023-03365-z. Epub 2023 Apr 19.
PubMed 37074559Pijl H, de Meijer PH, Langius J, Coenegracht CI, van den Berk AH, Chandie Shaw PK, Boom H, Schoemaker RC, Cohen AF, Burggraaf J, Meinders AE. Food choice in hyperthyroidism: potential influence of the autonomic nervous system and brain serotonin precursor availability. J Clin Endocrinol Metab. 2001 Dec;86(12):5848-53. doi: 10.1210/jcem.86.12.8112.
PubMed 11739450van Veenendaal NR, Rivkees SA. Treatment of pediatric Graves' disease is associated with excessive weight gain. J Clin Endocrinol Metab. 2011 Oct;96(10):3257-63. doi: 10.1210/jc.2011-1601. Epub 2011 Aug 17.
PubMed 21849528Chng CL, Lim AY, Tan HC, Kovalik JP, Tham KW, Bee YM, Lim W, Acharyya S, Lai OF, Chong MF, Yen PM. Physiological and Metabolic Changes During the Transition from Hyperthyroidism to Euthyroidism in Graves' Disease. Thyroid. 2016 Oct;26(10):1422-1430. doi: 10.1089/thy.2015.0602. Epub 2016 Sep 7.
PubMed 27465032Kim MJ, Cho SW, Choi S, Ju DL, Park DJ, Park YJ. Changes in Body Compositions and Basal Metabolic Rates during Treatment of Graves' Disease. Int J Endocrinol. 2018 May 3;2018:9863050. doi: 10.1155/2018/9863050. eCollection 2018.
PubMed 29853888Krassas GE, Pontikides N, Loustis K, Koliakos G, Constantinidis T, Panidis D. Resistin levels in hyperthyroid patients before and after restoration of thyroid function: relationship with body weight and body composition. Eur J Endocrinol. 2005 Aug;153(2):217-21. doi: 10.1530/eje.1.01963.
PubMed 16061827Hoogwerf BJ, Nuttall FQ. Long-term weight regulation in treated hyperthyroid and hypothyroid subjects. Am J Med. 1984 Jun;76(6):963-70. doi: 10.1016/0002-9343(84)90842-8.
PubMed 6731468Alton S, O'Malley BP. Dietary intake in thyrotoxicosis before and after adequate carbimazole therapy; the impact of dietary advice. Clin Endocrinol (Oxf). 1985 Nov;23(5):517-20. doi: 10.1111/j.1365-2265.1985.tb01111.x.
PubMed 4085132Lonn L, Stenlof K, Ottosson M, Lindroos AK, Nystrom E, Sjostrom L. Body weight and body composition changes after treatment of hyperthyroidism. J Clin Endocrinol Metab. 1998 Dec;83(12):4269-73. doi: 10.1210/jcem.83.12.5338.
PubMed 9851762
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06921304
- Acronym / sponsor ID
- BASEDIET / BASE-DIET 01
- Conditions
- Graves Disease
- Keywords
- graves disease, diet, body weight, PREDIMED
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 recently diagnosed with Graves' disease (Basedow's disease).
The main questions it aims to answer are:
- Can a dietary intervention prevent patients from regaining more than 1 kg above their pre-disease body weight after restoring euthyroidism?
- Does the intervention lead to improvements in body composition, dietary habits, and adherence to the Mediterranean diet? Researchers will compare patients receiving an Intensive Lifestyle Intervention (ILI) including a personalized diet and lifestyle counseling to patients receiving Usual Medical Care (UMC) with general lifestyle advice to see if the dietary intervention results in less weight regain and better metabolic and anthropometric outcomes.
Participants will:
- Receive antithyroid medication as standard medical care.
- Be randomized into either the intervention group (ILI) or control group (UMC).
If in the ILI group, participants will:
- Receive an individual nutritional consultation within 1 week of enrollment.
- Follow a personalized Mediterranean-style low-energy diet.
- Attend follow-up visits at 3, 6, 9, and 12 months for:
- Dietary adherence and lifestyle assessments.
- Anthropometric measurements (weight, BMI, waist/hip circumference).
- Bioimpedance analysis (at 6 and 12 months) for body composition.
- Dietary intake logs and adherence assessments (3-day food diary).
If in the UMC group, participants will:
- Receive routine clinical management for Graves' disease.
- Complete basic dietary and lifestyle questionnaires at baseline and 12 months.
- Undergo anthropometric measurements and bioimpedance at T0 and at the end of study.
This study aims to provide evidence on the role of nutritional support in managing weight and metabolic risks in patients undergoing treatment for Graves' disease.
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 condition) manage weight changes and improve their health during and after treatment.
Graves' disease often causes weight loss when it's active. But after treatment, many people gain back the weight-and sometimes even more than they had before. This study wants to find out if a personalized diet and lifestyle approach can help prevent that excessive weight gain and promote better health outcomes.
Why is this study important? When thyroid function is brought back to normal (called "euthyroidism"), many patients regain weight. In fact, up to 80% of patients report weight gain after treatment, which can impact self-esteem and health.
Some research shows this weight gain might go beyond what people weighed before getting sick. This study wants to see whether a structured diet and lifestyle program can make a positive difference compared to the usual medical care alone.
Who is participating in the study?
Adults newly diagnosed with Graves' disease at endocrinology clinics in Italy are invited to take part. Participants must:
- Be over 18 years old
- Have been diagnosed within the previous month
- Have a BMI between 16 and 35
- Be willing to commit to a 1-year program They cannot participate if they are pregnant, have certain health conditions, or are already taking weight-related medications.
How is the study organized?
The study randomly assigns people to one of two groups:
- Intervention Group (ILI) - This group receives:
- Personalized nutrition counseling by a licensed dietitian
- A Mediterranean-style, low-calorie diet plan
- Support on physical activity and lifestyle
- Follow-up appointments at 3, 6, 9, and 12 months
- Control Group (UMC) - This group receives:
- Standard medical care for Graves' disease
- General lifestyle and diet tips (no personalized plan)
- Two check-ins at the beginning and end of the 12-month period What is being measured? The main goal (primary outcome) is to see if people in the intervention group are less likely to gain more than 1 kg over their pre-disease weight after 12 months.
Secondary goals include:
- Changes in Body Mass Index (BMI)
- Body composition (muscle vs. fat mass)
- Waist-to-hip ratio
- Adherence to a Mediterranean diet
- Improved eating habits and quality of life What happens during follow-up?
At each check-up, researchers will:
- Measure weight, height, waist and hip size
- Use a body composition test (bioimpedance analysis)
- Review a 3-day food diary
- Ask about physical activity and lifestyle changes
- Check how closely participants follow the prescribed diet Only the intervention group receives repeated, in-depth dietary coaching. How long does the study last? The full study duration for each participant is 12 months, with an extended follow-up period for data collection.
How many people are in the study? The study plans to enroll 60 people (30 in each group), which accounts for a small number of possible dropouts.
Is the study safe and ethical?
Yes. It follows strict ethical guidelines:
- All participants give written informed consent
- Privacy is fully protected
- Participation is voluntary, and people can leave at any time There are no outside sponsors-it's a non-profit, academic study led by IRCCS Maugeri in Pavia, Italy.
What will happen with the results?
Results will be:
- Published in scientific journals
- Shared at medical conferences
- Made available to the public The goal is to better understand how diet can help people with Graves' disease manage their weight and improve their recovery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Medical Care (UMC) | No intervention | –Usual Medical Care for Graves' Disease and general lifestyle advice |
| Intensive Lifestyle Intervention (ILI) | Experimental | Behavioral: Intensive Lifestyle InterventionUsual Medical Care for Graves' Disease plus a personalized diet and lifestyle counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive Lifestyle InterventionILI combines a low-calorie dietary approach with improved lifestyle and physical activity, in addition to usual medical care. Behavioral support for lifestyle intervention will also be provided. | Behavioural | Intensive Lifestyle Intervention (ILI) |
Primary outcome
Body weight increase vs pre-disease weight
Time frame: Through study completion, an average of 1 year
Weight gain compared to the estimated pre-disease body weight. A 'failure' will be defined as a weight gain of more than 1 kg above the patient-reported estimated pre-disease body weight, assessed 12 months after the start of the study. Body weight and height will be combined to report BMI in kg/m^2
4 secondary outcomes
BMI changes
Time frame: Through study completion, an average of 1 year
Adherence to the Mediterranean Diet
Time frame: Through study completion, an average of 1 year
Changes in body composition parameters
Time frame: Through study completion, an average of 1 year
Changes in waist-to-hip ratio
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Background: PubMed 37074559Croce L, Pallavicini C, Busca N, Cali B, Bellastella G, Coperchini F, Magri F, Chiovato L, Cena H, Rotondi M. Pre-surgery dietician counseling can prevent post-thyroidectomy body weight gain: results of an intervention trial. Endocrine. 2023 Aug;81(2):246-251. doi: 10.1007/s12020-023-03365-z. Epub 2023 Apr 19.
- Background: PubMed 11739450Pijl H, de Meijer PH, Langius J, Coenegracht CI, van den Berk AH, Chandie Shaw PK, Boom H, Schoemaker RC, Cohen AF, Burggraaf J, Meinders AE. Food choice in hyperthyroidism: potential influence of the autonomic nervous system and brain serotonin precursor availability. J Clin Endocrinol Metab. 2001 Dec;86(12):5848-53. doi: 10.1210/jcem.86.12.8112.
- Background: PubMed 21849528van Veenendaal NR, Rivkees SA. Treatment of pediatric Graves' disease is associated with excessive weight gain. J Clin Endocrinol Metab. 2011 Oct;96(10):3257-63. doi: 10.1210/jc.2011-1601. Epub 2011 Aug 17.
- Background: PubMed 27465032Chng CL, Lim AY, Tan HC, Kovalik JP, Tham KW, Bee YM, Lim W, Acharyya S, Lai OF, Chong MF, Yen PM. Physiological and Metabolic Changes During the Transition from Hyperthyroidism to Euthyroidism in Graves' Disease. Thyroid. 2016 Oct;26(10):1422-1430. doi: 10.1089/thy.2015.0602. Epub 2016 Sep 7.
- Background: PubMed 29853888Kim MJ, Cho SW, Choi S, Ju DL, Park DJ, Park YJ. Changes in Body Compositions and Basal Metabolic Rates during Treatment of Graves' Disease. Int J Endocrinol. 2018 May 3;2018:9863050. doi: 10.1155/2018/9863050. eCollection 2018.
- Background: PubMed 16061827Krassas GE, Pontikides N, Loustis K, Koliakos G, Constantinidis T, Panidis D. Resistin levels in hyperthyroid patients before and after restoration of thyroid function: relationship with body weight and body composition. Eur J Endocrinol. 2005 Aug;153(2):217-21. doi: 10.1530/eje.1.01963.
- Background: PubMed 6731468Hoogwerf BJ, Nuttall FQ. Long-term weight regulation in treated hyperthyroid and hypothyroid subjects. Am J Med. 1984 Jun;76(6):963-70. doi: 10.1016/0002-9343(84)90842-8.
- Background: PubMed 4085132Alton S, O'Malley BP. Dietary intake in thyrotoxicosis before and after adequate carbimazole therapy; the impact of dietary advice. Clin Endocrinol (Oxf). 1985 Nov;23(5):517-20. doi: 10.1111/j.1365-2265.1985.tb01111.x.
- Background: PubMed 9851762Lonn L, Stenlof K, Ottosson M, Lindroos AK, Nystrom E, Sjostrom L. Body weight and body composition changes after treatment of hyperthyroidism. J Clin Endocrinol Metab. 1998 Dec;83(12):4269-73. doi: 10.1210/jcem.83.12.5338.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Lifestyle Intervention in people with Graves Disease, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight increase vs pre-disease weight (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06921304, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.