Menopausal Hormone Therapy, GLP-1 Agonists, and Glucose and Energy Homeostasis in Postmenopausal Women With Diabetes
Trial Parameters
Brief Summary
The overall aim is to investigate the hypothesis that restoring E2 levels through MHT improves glucose and energy homeostasis and potentiates the beneficial effects of GLP-1RA in early postmenopausal women with pre- or existing type 2 diabetes. The primary objective is to assess the efficacy of combined MHT and GLP-1RA in improving glucose control in early postmenopausal women with pre- or existing type 2 diabetes, compared to GLP-1RA alone. Secondary objectives include efficacy analyses on body weight, other measures of cardiometabolic health, lifestyle behaviour, menopausal symptoms, and the exploration of mechanisms underpinning potential glycaemic and weight control benefits, and biomarkers of haemostasis.
Eligibility Criteria
Individuals fulfilling at enrolment all of the following inclusion criteria are eligible for the study: * Early postmenopausal status (STRAW+10 stage +1b or +1c and FSH\>25.0mU/L) * Presence of menopausal symptoms (total MRS-II score ≥1) * BMI ≥ 27.0kg/m2 * Pre- or existing type 2 diabetes (HbA1c 5.7%-8.5%) * No prior or current use of MHT The presence of any of the following exclusion criteria will lead to exclusion of the individuals: * DPP4-inhibitor, SLGT2-inhibitor or sulfonylurea use within 8 weeks prior to study enrolment * GLP-1RA use within 6 months prior to study enrolment * Insulin therapy within 8 weeks prior to study enrolment * History of bariatric surgery * More than 2% change in body weight within three months prior to study enrolment (based on documented or reported weights) * Contraindications for the use of the study medication as per prescription labelling: Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2 * Kn