Menopausal Hormone Therapy, GLP-1 Agonists, and Glucose and Energy Homeostasis in Postmenopausal Women With Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorLia Bally
About this trial
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
Qualifiers
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%)
Disqualifiers
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
Trial design
Treatments tested in this trial
- GLP-1 Receptor Agonist
- Menopausal Hormone Therapy
Treatment groups
96 Participants
are divided into 3 treatment groupsSponsors and collaborators
Lia Bally
Lead sponsor
Insel Gruppe AG, University Hospital Bern
Sponsor institution
Source ClinicalTrials.gov