The Influence of Hormone Replacement Therapy and Supervised Exercise Training on Body Composition, Cardiovascular Risk and Insulin Sensitivity in Postmenopausal Women

Postmenopause Clinical Trial

— OPERATE  

Official title:

De Invloed Van Hormoonsubstitutietherapie en Gesuperviseerde Training op Lichaamssamenstelling, Cardiovasculair Risico en Insulinegevoeligheid Bij Postmenopauzale Vrouwen

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05831709
• Other study ID #: ONZ-2023-0015
• Status: Recruiting
• Phase: N/A
• Start date: May 12, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: University Hospital, Ghent
• Contact: Herman Depypere
• Phone: 003293323757
• Email: studieco.vrouwenkliniek[@]uzgent.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial investigates whether supervised training in combination with hormonal substitution therapy has an impact on body composition, cardiovascular risk and insulin sensitivity in postmenopausal women.

Description:

90 postmenopausal women will be included. Each women will perform a 12 weeks sport program with supervised training exercises.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2024
• Est. primary completion date: April 26, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

Inclusion Criteria:

• Postmenopausal women
• Good general health
• BMI: 20-30 kg/m2
• Only the use of cholesterol-, blood pressure- or/and thyroid-regulating medication is permitted

Exclusion Criteria:

• Women who are not yet in the menopause
• BMI <20- and >30 kg/m2
• Use of any other medication than cholesterol-, blood pressure- and thyroid-regulating medication

Related Conditions & MeSH terms

• Postmenopause

Intervention

Other:
• Exercise program
The intervention consists of a supervised exercise program

Locations

Country	Name	City	State
Belgium	Ghent University Hospital - Women's Clinic	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the cardiovascular risk	The cardiovascular risk will be estimated by blood- and urine analysis, blood pressure and a AGE (i.e. Advanced Glycation End products)-reader. There are two timepoints of measurement; once at inclusion and once at 12 weeks.	+12 weeks
Primary	Evaluation of the insulin sensitivity	The insulin sensitivity will be estimated by blood- and urine analysis and a AGE (i.e. Advanced Glycation End products)-reader. There are two timepoints of measurement; once at inclusion and once at 12 weeks.	+12 weeks
Secondary	Evaluation of the body composition	The body composition will be measured using bioimpedance technology (Tanita-scale). The body composition will be measured twice; once at inclusion and once at 12 weeks.	+12 weeks
Secondary	Evaluation of the muscle mass	The musle mass will be evaluated by performing a maximal effort test (i.e. cycling test). This test will be performed twice; once at inclusion and once at 12 weeks.	+12 weeks