No phaseActive, not recruitingAge-related condition
Menopausal Hormone Therapy, GLP-1 Agonists, and Glucose and Energy Homeostasis in Postmenopausal Women With Overweight/Obesity and Impaired Glucose Homeostasis (DECLARED-CT)
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 (Academic or other)
- Enrollment
- 96 planned
- Conditions
- Menopause; Type 2 Diabetes
- Interventions
- GLP-1 Receptor Agonist; Menopausal Hormone Therapy
- Ages
- adults, older adults
- Registry
- NCT06715514
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Change in HbA1C
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered