Pharmacogenetic Study of Different Hormone Therapies in Recent Menopause Women

N/ACompletedNCT01432028

Denusa Wiltgen90 enrolled

Overview

This is cross-over, randomized clinical trial, with objective to evaluate the effects of low-dose oral hormone therapy and non-oral hormone therapy on endothelial function markers (fibrinogen, von Willebrand factor, c-reactive protein), natriuretic peptide and on anthropometric, metabolic and hormonal variables in early and healthy postmenopausal women and analyzing polymorphisms in the estrogen receptor gene and FTO polymorphisms Patients will be randomized to receive oral hormone treatment or non-oral hormone treatment The investigators hypothesis is that a different genotypes in the receptor estrogen gene and FTO may have an influences on treatment response in metabolic markers and cardiovascular risk

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Postmenopause

Interventions

Eligibility

Sex: FEMALEMin age: 42 YearsMax age: 58 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria: * last menstrual period between 6 months and 3 years before the beginning of the study plus FSH levels higher than 35 IU/L; * age between 42 and 58 years; * no use of any medication known to interfere with hormonal, glucose, or lipoprotein levels in the past 3 months; * no use of steroidal or no steroidal anti-inflammatory drugs in the last 15 days. Exclusion criteria: * patients with diabetes, * previous hysterectomy, * endometrial thickness \>0.5cm, * history of cancer, * thromboembolism, or * established cardiovascular disease

Outcomes

Primary Outcomes

Polymorphisms of estrogen receptor

Influence of 4 polymorphisms (PVUII, ALUI, RSAI and BSTUI) on the effect of different treatment regimens. Change from Baseline in weight, waist circumference, BMI, systolic and diastolic blood pressure, fasting glucose, glucose at 120 min, Fasting insulin, HOMA, Cholesterol, HDL-c, LDL-c, Triglycerides, Von Willebrand Factor, Fibrinogen, Testosterone and C-reactive protein at six months.

Time frame: six months

Secondary Outcomes

Polymorphisms in the fat mass-and obesity-associated (FTO) gene

Influence of 2 polymorphisms (rs9939609 and rs8050136) on the effect of different treatment regimens. Change from Baseline in weight, waist circumference, BMI, systolic and diastolic blood pressure, fasting glucose, glucose at 120 min, Fasting insulin,HOMA, Cholesterol, HDL-c, LDL-c, Triglycerides, Von Willebrand Factor, Fibrinogen, Testosterone and C-reactive protein at six months.

Time frame: Six Months