The Effect of Pharmacotherapy With GLP-1 and GIP/GLP-1 Analogs on Changes in Qualitative and Quantitative Parameters of the Diet as Well as Metabolic and Behavioral Parameters in Patients With Excess Body Weight
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- change in body weight
研究概览
简要总结
The aim of this study is to comprehensively assess the early and long-term effects of GLP-1 and GIP/GLP-1 analogue medications on metabolic and behavioral parameters, with particular emphasis on qualitative and quantitative dietary changes in patients undergoing treatment for overweight and obesity. Participation in the study will involve four follow-up visits per year at the Clinic of Diabetology and Internal Medicine, Central Clinical Hospital, University Clinical Clinical Hospital, Medical University of Warsaw: before treatment initiation and after 3, 6, and 12 months. The analysis will focus not only on metabolic effects (weight loss, changes in body composition, and improved biochemical parameters), but also on nutritional and behavioral aspects, including diet, appetite regulation, risk of malnutrition and muscle loss, and the occurrence of adverse events. The study will allow for a multifaceted assessment of the impact of treatment with GLP-1 and GIP/GLP-1 analogues on patients with excess body weight.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years,
- •Diagnosed obesity (BMI ≥ 30 kg/m²) or overweight (BMI ≥ 27 kg/m²) with comorbidities associated with excess body weight (including type 2 diabetes, hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease),
- •Eligibility for treatment with GLP-1 or GIP/GLP-1 analogues,
- •Not taking GLP-1 and GIP/GLP-1 analogue medications for at least one year prior to study enrollment,
- •Ability to provide informed consent,
- •Informed consent to participate in the study.
排除标准
- •Age under 18 or over 65 years,
- •Inability to qualify for treatment with GLP-1 and GIP/GLP-1 analogues,
- •Pregnancy or breastfeeding,
- •Diagnosed eating disorders,
- •Active cancer or gastrointestinal conditions that may affect the absorption or tolerance of treatment (e.g., inflammatory bowel disease, conditions after extensive gastrointestinal resections, conditions after bariatric surgery),
- •Inability to participate in regular follow-up visits,
- •Inability to provide informed consent,
- •Failure to provide informed consent to participate in the study.
结局指标
主要结局
change in body weight
时间窗: 12 months
percentage change in body weight from baseline to the end of follow-up
次要结局
- Change in percent body fat(12 months)
- Change in fasting insulin concentration(12 months)
- Change in HOMA-IR(12 months)
- Change in liver enzymes and creatinine(12 months)
- Change in daily energy intake(12 months)
- Change in diet quality score (KomPAN)(12 months)
- Change in emotional eating score (TFEQ-R18)(12 months)
- Change in uncontrolled eating score (TFEQ-R18)(12 months)
- Change in cognitive restraint score (TFEQ-R18)(12 months)
- Change in lean body mass(12 months)
- Change in HbA1c(12 months)
- Change in daily protein intake(12 months)
- Change in sweet taste preference (VAS)(12 months)
- Change in total fat mass(12 months)
- Change in daily fat intake(12 months)
- Change in frequency of consumption of selected food groups(12 months)
- Change in preference for high-fat foods (VAS)(12 months)
- Change in subjective hunger (VAS)(12 months)
- Change in subjective satiety (VAS)(12 months)
- Change in fasting plasma glucose(12 months)
- Change in diabetes treatment(12 months)
- Change in lipid profile(12 months)
- Change in antihypertensive treatment(12 months)
- Change in daily carbohydrate intake(12 months)
- Change in preference for salty foods (VAS)(12 months)
- Change in preference for meat-based products (VAS)(12 months)
- Change in preference for fresh/fruit-based foods (VAS)(12 months)
- Change in risk of inadequate nutrient intake(12 months)
- Change in meal frequency(12 months)
- Change in mean daily step count(12 months)
- Change in handgrip strength(12 months)