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

Not Applicable

Recruiting

• Conditions: Postmenopause
• Interventions: Other: Exercise program

• Registration Number: NCT05831709
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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

Detailed Description

270 postmenopausal women will be included. Each woman will perform a 12 to 24 weeks sports program with supervised training exercises.

Study Timeline

• Study First Submitted: 2023-04-12
• Study First Submitted QC: 2023-04-25
• Study First Posted: 2023-04-26
• Study Start: 2023-05-12
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-27
• Primary Completion: 2027-12-31
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 270

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supervised training + immediate hormone substitution therapy	Exercise program	-
Supervised training + delayed hormone substitution therapy	Exercise program	-
Delayed supervised training + immediate hormone substitution therapy	Exercise program	-

Primary Outcome Measures

Name	Time	Method
Evaluation of the insulin sensitivity	+12 weeks	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.
Evaluation of the cardiovascular risk	+12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Evaluation of the muscle mass	+12 weeks	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.
Evaluation of the body composition	+12 weeks	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.

Trial Locations

Locations (1)

Ghent University Hospital - Women's Clinic; 🇧🇪 Ghent, Belgium