Evaluation of Food Preferences in Patients Treated Surgically for Craniopharyngiomas
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 346
- 试验地点
- 1
- 主要终点
- Psychometric validation of the French food preference questionnaire (FPQ): phase 1
研究概览
简要总结
The hypothalamus plays a key role in regulating appetite, satiety, and energy balance. When tumors such as craniopharyngiomas develop in this region, they can disrupt these mechanisms and lead to a form of severe weight gain known as hypothalamic obesity. Several factors play a role in the development of hypothalamic obesity that is often resistant to traditional treatments. Changes in food preferences notably a higher liking for food rich in fat and sugar may be implicated as has been reported in common obesity.
The working hypothesis of the study is that hypothalamic lesions may alter food preferences, leading to an increased preference for high-fat and high-sugar foods, and that these changes in dietary choices contribute among other factors to the development of hypothalamic obesity.
By providing the first evaluation of food preferences in adults treated surgically for craniopharyngiomas, this study will shed light on the role of hypothalamic lesions in modifying dietary choices. The results may help explain why some patients experience rapid and resistant weight gain, and could guide future strategies to better manage hypothalamic obesity.
详细描述
Hypothalamic obesity is a rare but severe condition characterized by rapid and often refractory weight gain following hypothalamic lesions. Among suprasellar tumors, craniopharyngiomas are the most frequent, and up to 40% of patients present with obesity at diagnosis. Over the course of treatment, including surgical management, the prevalence of obesity may rise to 60%. The most pronounced weight gain typically occurs within the first year after surgery. This weight increase is multifactorial, involving hypothalamic damage to nuclei regulating appetite and satiety, neuroendocrine dysfunction, reduced basal metabolic rate, decreased physical activity, and autonomic imbalance leading to hyperinsulinism. Additional contributors include neurocognitive and sleep disturbances, visual impairment, and medication side effects.
Beyond the quantitative increase in food intake, food palatability is a key determinant of dietary choices and caloric intake. Highly palatable foods, generally rich in fats and sugars, stimulate brain reward circuits, reinforcing their consumption and thereby promoting excess caloric intake and weight gain. While such mechanisms have been described in common obesity, food preferences have never been systematically investigated in patients with hypothalamic lesions, particularly those with craniopharyngiomas. Animal studies suggest that the lateral hypothalamus plays a critical role in responses to addictive substances as well as to fat and sugar consumption, raising the hypothesis that hypothalamic tumors may alter food preferences in humans and contribute to hypothalamic obesity.
This study, entitled PREFAMHYPO, is a two-phase, non-interventional observational clinical investigation designed to explore the role of food preferences in hypothalamic obesity.
Study Objectives and Design
The study has two main phases:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Common inclusion criteria: complete medical record accessible, capacity to understand and complete self-administered questionnaires, agreement to complete the questionnaires at the time of inclusion, adult subject, not in an emergency situation, provision of non-opposition (opt-out consent documented), affiliation to a social security scheme.
- •Inclusion (Phase 1): Adults residing in France, aged 18 - 74 years from the general population.
- •Inclusion (Phase 2): Adults aged 18 - 74 years;
- •Group 1: patients with craniopharyngioma surgery ≥ 3 months prior to inclusion.
- •Group 2: patients with pituitary macroadenoma surgery with documented ≥ 2 anterior pituitary deficits.
- •Group 3: Follow-up for an endocrine condition without hypothalamo-hypophyseal involvement, acceptable conditions (thyroid nodule without dysthyroidism, PCOS, peripheral hirsutism, calcium metabolism disorders), no known treatments or prior medical history likely to influence eating behaviour.
排除标准
- •Common exclusion criteria: bariatric surgery, GLP-1 agonist treatment, chronic disease affecting alimentation, pregnancy or breastfeeding, specific diets (gluten-free, vegetarian, vegan...), refusal or opposition to data use, vulnerability status (under guardianship or legal protection) or inability to complete questionnaires or to understand the proposed research or to express a clear opinion regarding non-opposition.
- •Additional exclusion criteria:
- •phase 1: Type 1 or type 2 diabetes, Active smoking, alcohol misuse, drug use, diagnosed psychiatric disorders or eating behaviour disorders.
- •Person benefiting from State Medical Aid (AME).
- •Control group:
- •Hypothalamo-hypophyseal pathology, type 1 or type 2 diabetes, uncontrolled hyperthyroidism or hypothyroidism, adrenal hormone hypersecretion disorder, history of or ongoing treatment for active cancer.
研究组 & 干预措施
groups 1: Craniopharyngioma patients
40 adults surgically treated for craniopharyngioma (≥ 3 months post-surgery).
Control participants
80 adults without hypothalamic-pituitary disease, matched on age, sex, and BMI with groups 1 and 2.
groups 2: Pituitary macroadenoma patients
40 adults surgically treated for pituitary macroadenoma with ≥ 2 anterior pituitary hormone deficiencies.
结局指标
主要结局
Psychometric validation of the French food preference questionnaire (FPQ): phase 1
时间窗: at baseline
Validation of the French version of the Food Preference Questionnaire (FPQ) in an adult population in France. The Food Preference Questionnaire (FPQ) is the primary tool used to evaluate participants' food preferences for 62 food items, such as meats, dairy products, cereals, fruits, vegetables, and snack foods. For each item, participants indicate their degree of liking using a 6-point response scale from "dislike strongly" to "like strongly" ("Do not like at all", "Dislike moderately", "Neutral", "Like a little", "Like very much", "Not applicable"), allowing quantification of preference intensity across food types. Validity will be evaluated through exploratory and confirmatory factor analyses, while reliability will be assessed using internal consistency (Cronbach's alpha coefficient) and reproducibility (test-retest).
Evaluation of scores measuring FPQ: phase 2
时间窗: at baseline
The main objective is to characterize food preferences in patients operated on for a craniopharyngioma by comparing them with two control groups: patients operated on for a pituitary macroadenoma with anterior pituitary insufficiency, and a control population matched for age, sex, and body mass index (BMI), calculated as mass (kg) /(height in m)\^2. The questionnaire validated in phase 1 will be used and questionnaire results will be analyzed quantitatively to identify specific food preference profiles within each group and to explore potential associations with clinical and metabolic parameters.
次要结局
- Collecte of BMI(at baseline)
- Evaluation of the Fat Preference(at baseline)
- Evaluate of eating behaviors(at baseline)
- Assessment of physical activity(at baseline)
- Collecte of Waist Circumference(at baseline)
- Collecte of Body Composition(at baseline)