Menopausal Hormone Therapy, GLP-1 Agonists, and Glucose and Energy Homeostasis in Postmenopausal Women With Diabetes

Launched by LIA BALLY · Nov 28, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how menopausal hormone therapy (MHT) combined with GLP-1 agonists can help improve blood sugar control and overall health in women who are early in menopause and have type 2 diabetes. The researchers believe that restoring hormone levels may enhance the benefits of GLP-1 medications, which are often used to manage diabetes. They will compare the effects of this combination treatment to GLP-1 medications alone, looking not only at blood sugar levels but also at weight, heart health, lifestyle habits, and menopausal symptoms.

To participate in this study, women aged 65 to 74 must be early in menopause and experiencing menopausal symptoms, have a body mass index (BMI) of 27 or higher, and have pre-existing or newly diagnosed type 2 diabetes. Participants should not have used hormone therapy before the study and must meet other specific health criteria. Those who join the trial can expect to receive either the combination treatment or the GLP-1 medication alone, along with regular check-ups to monitor their health and progress. This study aims to provide valuable insights into managing diabetes and menopause together, which could lead to better treatment options in the future.

Gender

FEMALE

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
• • Known or suspected cancer of breast or other sexual organ, abnormal genital bleeding of unknown cause, hepatic neoplasia
• • Arterial or venous thromboembolic events, porphyria
• • Known allergy or hypersensitivity to Wegovy®, Estradot® or Utrogestan® (pharmaceutical agents or any of the excipients)
• • Systemic hormone therapy or hormonal contraceptives (e.g. estrogens, progestogens, androgens) during the study and within 12 months prior to participation
• • Herbal remedies and complimentary medicines for menopausal symptoms during the study
• • Physical or psychological condition or any medical intervention (including medication not specified above) likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator
• • Participation in another clinical trial that interferes with the interpretation of the study results
• • Inability to read German
• • Unwillingness to follow the study procedures