Investigating hormone therapy and GLP-1 agonists for diabetes management in postmenopausal women
Effects of Combined Menopausal Hormone Therapy and GLP-1 Receptor Agonist Therapy on Glucose and Energy Homeostasis in Early Postmenopausal Women With or at Risk of Diabetes
NA · Insel Gruppe AG, University Hospital Bern · NCT06715514
This study is testing if adding hormone therapy to a diabetes medication can help early postmenopausal women with type 2 diabetes manage their blood sugar and improve their overall health.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Insel Gruppe AG, University Hospital Bern (other) |
| Locations | 1 site (Bern) |
| Trial ID | NCT06715514 on ClinicalTrials.gov |
What this trial studies
This study aims to explore how restoring estradiol levels through menopausal hormone therapy (MHT) can improve glucose and energy balance in early postmenopausal women with type 2 diabetes. It will compare the effects of combined MHT and GLP-1 receptor agonists (GLP-1RA) against GLP-1RA alone on glucose control and other health measures. Secondary objectives include assessing body weight, cardiometabolic health, lifestyle behaviors, menopausal symptoms, and the underlying mechanisms of these effects. The study will involve randomized controlled methods to ensure robust results.
Who should consider this trial
Good fit: Ideal candidates are early postmenopausal women with a BMI of 27 or higher and pre-existing type 2 diabetes.
Not a fit: Patients who have recently used certain diabetes medications or have contraindications for MHT may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic approach to improve glucose control and overall health in postmenopausal women with diabetes.
How similar studies have performed: While the approach of combining MHT with GLP-1RA is innovative, similar studies have shown promising results in related areas, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bern
- University Hospital Bern — Bern, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Prof. Dr. med. et Dr. phil.Lia Bally — Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital
- Study coordinator: Prof. Dr. med. et Dr. phil.Lia Bally
- Email: lia.bally@insel.ch
- Phone: +41 31 632 36 77
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Menopause, Type 2 Diabetes, Diabetes, Menopausal Hormone Therapy, Womens Health, Randomized Controlled Trial, GLP-1 receptor agonist