Clinical trial NCT02237079: Bazedoxifene/Conjugated Estrogens (BZA/CE) Improvement of Metabolism (BIM)
Official title: Bazedoxifene/Conjugated Estrogens (BZA/CE) Improvement of Metabolism (BIM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Glucose Homeostasis
Postmenopausal Symptoms
Lead sponsor: Tulane University
Sponsor class: OTHER
First posted: 2014-09-11
Enrollment: 17
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this pilot clinical study is to perform a randomized placebo-controlled study to assess the beneficial effect of a 3 month-treatment with Bazedoxifene/Conjugated Estrogens (BZA/CE) vs. placebo on glucose homeostasis and body composition in 20 post-menopausal women. The recruitment will be performed at Tulane Health Sciences Center.


Eligibility criteria: Inclusion Criteria:

* Post-menopausal women (\<5y since final menstrual period) with age between 50-60y
* Symptomatic (hot flashes, vaginal dryness) or asymptomatic
* BMI 26-45 kg/m2 (Overweight, Obesity I and Obesity II)
* Fasting glucose \<125mg/dl
* Triglycerides \<200mg/dl
* Normal mammogram within past 12 months
* Physician clearance

Exclusion Criteria:

* Amenorrhea from other causes (Hyperandrogenemia and anovulation)
* type 2 and type 1 diabetes
* Medications: diabetes or diabetic drugs, dyslipidemia, estrogen/progestin therapy, antidepressants and antipsychotics, antiretroviral (HIV), oral steroids, weight loss drugs
* ≤ 3 month washout of birth control pill (often prescribed for postmenopausal symptoms)
* Hysterectomy (partial or complete)
* Contraindications to estrogen treatment (unusual vaginal bleeding, blot clots, hepatic disease, bleeding disorder, past/present history of breast or uterine cancer, pregnant, breastfeeding)

Primary outcomes:
measure: Change in Body Mass Index
timeFrame: Change at 3 months from baseline
measure: Effect of CE/BZA on Body Composition Using Waist-to-hip Ratio
timeFrame: Change at 3 months from baseline
measure: Change in Body Composition Using Dual-energy X-ray Absorptiometry (DXA)
timeFrame: Change at 3 months from baseline
measure: Change in Acute Insulin Response to Glucose (AIRg)
timeFrame: Change at 3 months from baseline
measure: Change in Basal Glucose Concentration (Gb)
timeFrame: Change at 3 months from baseline
measure: Change in Disposition Index (DI)
timeFrame: Change at 3 months from baseline
measure: Change in Insulin Sensitivity (SI) Index
timeFrame: Change at 3 months from baseline
measure: Change in Homeostatic Model Assessment (HOMA) β-cell Function
timeFrame: Change at 3 months from baseline
measure: Change in Homeostatic Model Assessment (HOMA) Insulin Resistance (IR)
timeFrame: Change at 3 months from baseline
measure: Change in Fasting Insulin Clearance (FIC)
timeFrame: Change at 3 months from baseline
measure: Change in Glucose-stimulated Insulin Clearance (GSIC)
timeFrame: Change at 3 months from baseline
Secondary outcomes:
measure: Measure Change in Serum Biomarkers Panel 1
timeFrame: Change at 3 months from baseline
measure: Measure Change in Serum Biomarkers Panel 2
timeFrame: Change at 3 months from baseline
measure: Measure Change in Leptin:Adiponectin Ratio (LAR)
timeFrame: Change at 3 months from baseline
measure: Measure Change in Fibroblast Growth Factor-21 (FGF-21)
timeFrame: Change at 3 months from baseline
measure: Measure Change in C-Reactive Protein (CRP)
timeFrame: Change at 3 months from baseline
measure: Measure Change in Thiobarbituric Acid Reactive Substance (TBARS)
timeFrame: Change at 3 months from baseline
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Tulane University Clinical Translational Unit
state: Louisiana
Study officials:
affiliation: Tulane University
name: Franck Mauvais-Jarvis, MD
role: PRINCIPAL_INVESTIGATOR
References: