Type 2 Diabetes (T2D) Clinical Trials

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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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Switzerland
University Hospital Bern
RECRUITING
Bern
Contact Information
Primary
Prof. Dr. med. et Dr. phil.Lia Bally
lia.bally@insel.ch
+41 31 632 36 77
Time Frame
Start Date: 2025-02-18
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 96
Treatments
Other: Menopausal Hormone Therapy
Estradot®: 50 micrograms/24h, transdermal patch E2;~Utrogestan®\*: once daily 200mg of micronized progesterone (in women with intact uterus\*)
Active_comparator: GLP-1 Receptor Agonist
Wegovy®: Semaglutide injected once weekly, starting dose 0.25mg, with dose increments every four weeks reaching the maintenance dose of 1mg after eight weeks
Experimental: Combined Menopausal Hornome Therapy and GLP-1 Receptor Agonist
Wegovy®: Semaglutide injected once weekly, starting dose 0.25mg, with dose increments every four weeks reaching the maintenance dose of 1mg after eight weeks; Estradot®: 50 micrograms/24h, transdermal patch E2; Utrogestan®\*: once daily 200mg of micronized progesterone (in women with intact uterus)
Related Therapeutic Areas
Sponsors
Leads: Lia Bally

This content was sourced from clinicaltrials.gov