Postmenopause Clinical Trial
— OPERATEOfficial title:
De Invloed Van Hormoonsubstitutietherapie en Gesuperviseerde Training op Lichaamssamenstelling, Cardiovasculair Risico en Insulinegevoeligheid Bij Postmenopauzale Vrouwen
NCT number | NCT05831709 |
Other study ID # | ONZ-2023-0015 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 12, 2023 |
Est. completion date | May 1, 2025 |
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.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | May 1, 2025 |
Est. primary completion date | May 1, 2025 |
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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Ghent University Hospital - Women's Clinic | Ghent |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Ghent |
Belgium,
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 |
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