Change in Glycated Hemoglobin (HbA1c)
Change from baseline in glycated hemoglobin (HbA1c, %) measured using standard clinical laboratory assays as a marker of glycemic control and cardiometabolic risk.
Time frame: Baseline to 6 months and Baseline to 12 months
Histological Complete Response Rate of Endometrial Lesion
Percentage of patients achieving complete histological response of the endometrial lesion assessed by endometrial biopsy with or without hysteroscopy. Histological evaluation is performed by gynecologic pathologists using standardized pathological criteria. Complete response is defined as absence of endometrial carcinoma or atypical hyperplasia on biopsy during follow-up.
Unit of Measure: Percentage of patients (%).
Time frame: Baseline to 6 months and 12 months
Proportion of patients reaching eligibility for minimally invasive surgery
Proportion of patients who meet predefined clinical criteria for minimally invasive hysterectomy after multimodal optimization, including adequate metabolic improvement, anesthetic clearance, functional capacity, and absence of disease progression on pathology or imaging. Eligibility is determined by the multidisciplinary tumor board and surgical team.
Time frame: Up to 12 months
Change in Health-Related Quality of Life Score (SF-36)
Change from baseline in health-related quality of life assessed using the Short Form-36 Health Survey (SF-36) questionnaire. The SF-36 evaluates multiple domains of physical and mental health. Scores range from 0 to 100, with higher scores indicating better health-related quality of life..
Time frame: Baseline to 12 months
Incidence of adverse events related to standard-of-care treatments
Frequency, severity, and type of adverse events associated with standard-of-care treatments, including semaglutide and hormonal therapy. Events are documented through clinical records and routine follow-up visits, classified according to CTCAE criteria, and categorized as mild, moderate, severe, serious, or treatment-limiting. Only events occurring during active management and follow-up are included
Time frame: Baseline to 12 months
Perioperative outcomes following minimally invasive surgery
Perioperative outcomes in patients who undergo minimally invasive hysterectomy after optimization, including operative time, estimated blood loss, conversion to laparotomy, intraoperative complications, hospital stay, 30-day postoperative complications, and readmission. Complications will be graded according to Clavien-Dindo classification.
Time frame: At time of surgery and 30 days postoperatively
Changes in anthropometric measures (BMI, waist circumference, visceral adiposity)
Change in BMI, waist circumference, and percent weight loss categories (≥5%, ≥10%, ≥15%). Measurements taken at scheduled visits and analyzed longitudinally to evaluate response to multimodal optimization.
Time frame: Up to 12 months
Adherence to GLP-1 therapy, hormonal therapy, diet, and exercise interventions
Adherence to semaglutide, hormonal therapy (LNG-IUD ± oral progestins), dietary plan, and structured exercise program, including reasons for modification or discontinuation. Data obtained from clinical records, pharmacy dispensation, and self-reported logs.
Time frame: Baseline to 12 months
Change in Fasting Plasma Glucose
Change from baseline in fasting plasma glucose concentration (mg/dL) measured using standard biochemical laboratory analysis.
Time frame: Baseline to 6 months and Baseline to 12 months
Change in Serum Triglycerides
Change from baseline in serum triglyceride levels (mg/dL) measured using routine clinical laboratory lipid panel testing.
Time frame: Baseline to 6 months and Baseline to 12 months
Change in HDL Cholesterol
Change from baseline in high-density lipoprotein (HDL) cholesterol levels (mg/dL) measured using standard lipid panel testing.
Time frame: Baseline to 6 months and Baseline to 12 months
Change in LDL Cholesterol
Change from baseline in low-density lipoprotein (LDL) cholesterol levels (mg/dL) measured using standard lipid panel testing.
Time frame: Baseline to 6 months and Baseline to 12 months
Change in Blood Pressure
Change from baseline in systolic and diastolic blood pressure (mmHg) measured using standard clinical sphygmomanometry during routine clinical visits
Time frame: Baseline to 6 months and Baseline to 12 months
Change in C-Reactive Protein (CRP)
Change from baseline in serum C-reactive protein concentration (mg/L) measured using standard laboratory assays as a marker of systemic inflammation.
Time frame: Baseline to 6 months and Baseline to 12 months
Change in Quality of Life Score (EORTC QLQ-C30)
Change from baseline in quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). The questionnaire evaluates global health status, functional scales, and symptom scales in oncology patients. Scores range from 0 to 100 according to EORTC scoring guidelines.
Time frame: Baseline to 12 months
Change in Functional Capacity
Change from baseline in functional capacity assessed using standardized physical activity tolerance or performance measures recorded during clinical follow-up visits.
Time frame: Baseline to 12 months
