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

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05831709

Acronym

OPERATE

Enrollment

390

Registered

2023-04-26

Start date

2023-05-12

Completion date

2028-12-31

Last updated

2025-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menopausal Complaints, Postmenopause

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.

Interventions

OTHERExercise program

The intervention consists of a supervised exercise program

DRUGHormonal substitution therapy per SOC

Subjects take hormonal substitution therapy per standard of care

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Postmenopausal women (diagnosed by physician) with complaints due to menopause * Indication for hormonal substitution therapy (except for the control group) * Good general health * BMI: 20-30 kg/m2 * Only the use of cholesterol-, blood pressure- or/and thyroid-regulating medication is permitted

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of the cardiovascular risk	+12 weeks; +24 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 three timepoints of measurement; once at inclusion, once at 12 weeks, and once at 24 weeks.
Evaluation of the insulin sensitivity	+12 weeks, +24 weeks	The insulin sensitivity will be estimated by blood- and urine analysis and a AGE (i.e. Advanced Glycation End products)-reader. There are three timepoints of measurement; once at inclusion, once at 12 weeks, and once at 24 weeks.

Secondary

Measure	Time frame	Description
Evaluation of the body composition	+12 weeks; +24 weeks	The body composition will be measured using bioimpedance technology (Tanita-scale). The body composition will be measured three times; once at inclusion, once at 12 weeks and once at 24 weeks.
Evaluation of the muscle mass	+12 weeks; +24 weeks	The musle mass will be evaluated by performing a maximal effort test (i.e. cycling test). This test will be performed three times; once at inclusion, once at 12 weeks, and once at 24 weeks.

Countries

Belgium

Contacts

Primary ContactHerman Depypere

studieco.vrouwenkliniek@uzgent.be003293323783

Backup ContactStudy coordinator Women's Clinic