RecruitingNot ApplicableNCT06715514

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

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


Sponsor

Lia Bally

Enrollment

96 participants

Start Date

Feb 18, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining how menopausal hormone therapy (MHT) and GLP-1 medications (a class of type 2 diabetes and weight-loss drugs) interact to affect blood sugar control and energy use in postmenopausal women with diabetes or prediabetes. **You may be eligible if...** - You are in early postmenopause (confirmed by hormone levels) - You have menopausal symptoms - You have a BMI of 27 or above - You have prediabetes or type 2 diabetes with an HbA1c between 5.7% and 8.5% - You have never used menopausal hormone therapy before **You may NOT be eligible if...** - You have used GLP-1 medications (like Ozempic or Wegovy) in the past 6 months - You have used insulin or other diabetes medications recently - You have had bariatric (weight-loss) surgery - You have a personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 - You have a history of breast cancer, unexplained vaginal bleeding, blood clots, or porphyria - You are currently using hormonal contraceptives or other hormone therapies Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGLP-1 Receptor Agonist

Wegovy®

DRUGMenopausal Hormone Therapy

Estradot® and Utrogestan®\* (in women with intact uterus\*)


Locations(1)

University Hospital Bern

Bern, Switzerland

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NCT06715514


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