Resting Energy Expenditure in Postmenopausal Women

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorInsel Gruppe AG, University Hospital Bern

About this trial

Obesity and its associated comorbidities are rising at an alarming rate, particularly among postmenopausal women. Menopause, characterized by a decline in estradiol and progesterone levels, is often accompanied by weight gain. Fear of this weight gain is a major reason why many women hesitate to initiate or continue menopausal hormone therapy (MHT), with discontinuation often occurring within the first few months. However, scientific evidence on whether MHT influences weight gain remains inconclusive. A Cochrane Review found no significant effect of estrogen or combined estrogen-progestogen therapy on menopause-related weight gain, suggesting that aging and lifestyle changes play a more prominent role.

While the effects of estrogen on energy intake have been well-documented, data on its impact on energy expenditure-particularly resting energy expenditure (REE), the largest component of total energy expenditure-are scarce. Several studies suggest that sex hormones may influence REE, as observed in premenopausal women, where REE increases during the luteal phase when estradiol and progesterone levels are high. However, findings on this topic remain inconsistent, and it is unclear whether estrogen or progesterone plays the primary role. Research on the effects of exogenous hormone administration, such as MHT, on REE is extremely limited, with existing studies producing mixed results. Additionally, the potential influence of progestogens on REE has been largely overlooked. Given that a low REE is a strong predictor of weight gain and obesity, understanding the effects of MHT on REE is crucial.

This observational clinical trial aims to investigate the precise effect of MHT (estradiol + progesterone) on REE in postmenopausal women with an indication for MHT. Secondary objectives include examining MHT's impact on energy intake, physical activity energy expenditure, performance capacity, body composition, core body temperature, serum hormone profiles (luteinizing hormone, follicle-stimulating hormone, estradiol, progesterone), glucose metabolism, fasting blood lipid levels, and miRNA expression (miR-370 and miR-29b, which are involved in lipid and glucose metabolism). Additionally, the study will assess various aspects of subjective well-being and quality of life.

By addressing the current gaps in scientific knowledge, this study seeks to provide robust evidence on the role of MHT in energy metabolism, potentially reshaping perspectives on its risks and benefits in postmenopausal women.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Informed Consent as documented by signature

Healthy postmenopausal woman

Indication for MHT (e.g. climacteric syndrome, osteoporosis, etc.)

Body Mass Index (BMI) 18.5 - 29.9 kg/m2

Disqualifiers

Pregnancy or Lactation

Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)

Systemic hormone therapy or hormonal contraception (estrogens, progestogens, androgens) during the study and within 12 weeks prior to study entry

Phytotherapeutics for therapy of climacteric syndrome during the study and within 12 weeks prior to study entry

Trial population

Postmenopausal women with an indication for MHT (e.g. climacteric syndrome, osteoporosis, etc.). Women will be recruited at the University Hospital of Bern, Switzerland - Department of Gynecological Endocrinology and Reproductive Medicine.

Trial design

Design model

Case-crossover

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

37 Participants
are grouped into 1 trial group
Group A: Menopausal Hormone Therapy (MHT)

Trial outcomes

Primary outcomes

1

Resting Energy Expenditure (REE)

Difference in absolute REE (kcal/day) before hormonal substitution and after four weeks of MHT

Time frame
4 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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