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NCT Number: NCT05831709

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

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.

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Key information

Conditions

Postmenopause Menopausal Complaints

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University Hospital - Women's Clinic

Ghent, 9000, Belgium

Location status: Recruiting

Location contact

CONTACT

[email protected]

+3293320758

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

exercise program

Other

The intervention consists of a supervised exercise program

Hormonal substitution therapy per SOC

Drug

Subjects take hormonal substitution therapy per standard of care

Primary outcomes

  1. Evaluation of the cardiovascular risk

    Time frame: +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.

  2. Evaluation of the insulin sensitivity

    Time frame: +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 outcomes

  1. Evaluation of the body composition

    Time frame: +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.

  2. Evaluation of the muscle mass

    Time frame: +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.

Study contacts

Contact information is provided by the study sponsor or research team.

Herman Depypere

CONTACT

[email protected]

003293323783

Study coordinator Women's Clinic

CONTACT

[email protected]

003293323783

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

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

Acronym: OPERATE

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Apr 26, 2023
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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