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

Sponsor
University Hospital, Ghent (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05831709
Collaborator
(none)
90
Enrollment
3
Arms
20.2
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Exercise program
 N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
De Invloed Van Hormoonsubstitutietherapie en Gesuperviseerde Training op Lichaamssamenstelling, Cardiovasculair Risico en Insulinegevoeligheid Bij Postmenopauzale Vrouwen
Anticipated Study Start Date :
Apr 26, 2023
Anticipated Primary Completion Date :
Apr 26, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Supervised training + immediate hormone substitution therapy

Other: Exercise program
The intervention consists of a supervised exercise program
Experimental: Supervised training + delayed hormone substitution therapy

Other: Exercise program
The intervention consists of a supervised exercise program
Active Comparator: Delayed supervised training + immediate hormone substitution therapy

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

Secondary Outcome Measures

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital, Ghent

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT05831709
Other Study ID Numbers:
  • ONZ-2023-0015
First Posted:
Apr 26, 2023
Last Update Posted:
Apr 26, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 26, 2023