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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Body weight increase vs pre-disease weight
研究概览
简要总结
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.
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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.
详细描述
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?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Usual Medical Care (UMC)
Usual Medical Care for Graves' Disease and general lifestyle advice
Intensive Lifestyle Intervention (ILI)
Usual Medical Care for Graves' Disease plus a personalized diet and lifestyle counseling
干预措施: Intensive Lifestyle Intervention (Behavioral)
结局指标
主要结局
Body weight increase vs pre-disease weight
时间窗: 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
次要结局
- Adherence to the Mediterranean Diet(Through study completion, an average of 1 year)
- BMI changes(Through study completion, an average of 1 year)
- Changes in body composition parameters(Through study completion, an average of 1 year)
- Changes in waist-to-hip ratio(Through study completion, an average of 1 year)
研究者
Laura Croce
Professor
Istituti Clinici Scientifici Maugeri SpA