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Completed

NCT Number: NCT02237079

Bazedoxifene/Conjugated Estrogens (BZA/CE) Improvement of Metabolism (BIM)

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.

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Key information

Conditions

Obesity Body Weight Glucose Homeostasis Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Postmenopausal Symptoms Signs and Symptoms

Age range

50 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Tulane University Clinical Translational Unit

New Orleans, Louisiana, 70112, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Bazedoxifene/Conjugated Estrogens (BZA/CE)

Drug

Daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg.

Other names: DUAVEE

Placebo oral tablet

Drug

Daily placebo tablet

Primary outcomes

  1. Change in Body Mass Index

    Time frame: Change at 3 months from baseline

    Body composition will be assessed through change in body mass index at baseline and at 3 months post-treatment.

  2. Effect of CE/BZA on Body Composition Using Waist-to-hip Ratio

    Time frame: Change at 3 months from baseline

    Body composition will be assessed through change in waist-to-hip ratio at baseline and at 3 months post-treatment.

  3. Change in Body Composition Using Dual-energy X-ray Absorptiometry (DXA)

    Time frame: Change at 3 months from baseline

    Dual-Energy X-ray Absorptiometry was used to assess body composition. DXA uses an x-ray technique to look at the density of the body and can then estimate the amount of lean muscle mass and fat tissue. Body composition will be assessed through change in DXA body composition at baseline and at 3 months post-treatment.

  4. Change in Acute Insulin Response to Glucose (AIRg)

    Time frame: Change at 3 months from baseline

    This will be assessed through an IV Glucose Tolerance Test (IVGTT) conducted at baseline and 3 months to measure the change in acute insulin response to glucose. IVGTT data derived by MINMOD Millennium software. MINMOD: a computer program to calculate insulin sensitivity and pancreatic responsivity from the frequently sampled intravenous glucose tolerance test. Acute Insulin Response (AIRg) to Intravenous Glucose is based on glucose and insulin levels obtained during the frequently sampled intravenous glucose tolerance test and calculated using a mathematical model. AIRg is measured as the magnitude of the insulin response to an intravenous glucose injection following glucose administration. A low AIRg indicates decreased ability of the pancreas to secrete insulin.

  5. Change in Basal Glucose Concentration (Gb)

    Time frame: Change at 3 months from baseline

    This will be assessed through an IV Glucose Tolerance Test (IVGTT) conducted at baseline and 3 months to measure the change in basal glucose concentration. IVGTT data derived by MINMOD Millennium software.

  6. Change in Disposition Index (DI)

    Time frame: Change at 3 months from baseline

    Disposition index (DI) is the product of insulin sensitivity times the amount of insulin secreted in response to blood glucose levels. DI is commonly used as a measure of β-cell function. This will be assessed through an IV Glucose Tolerance Test (IVGTT) conducted at baseline and 3 months to measure the change in disposition index (DI). IVGTT data derived by MINMOD Millennium software. DI is based on glucose and insulin levels obtained during the frequently sampled intravenous glucose tolerance test and calculated using a mathematical model. DI is the product of insulin sensitivity and the amount of insulin secreted in response to blood glucose levels. Disposition index is used as a measure of beta cell function and the ability of the body to dispose of a glucose load. A low DI is indicative of a higher risk of developing diabetes.

  7. Change in Insulin Sensitivity (SI) Index

    Time frame: Change at 3 months from baseline

    SI indicates the net capacity for insulin to promote the disposal of glucose and to inhibit the endogenous production of glucose. This will be assessed through an IV Glucose Tolerance Test (IVGTT) conducted at baseline and 3 months to measure the change in insulin sensitivity (SI) index. IVGTT data derived by MINMOD Millennium software. SI is based on glucose and insulin levels obtained during the frequently sampled intravenous glucose tolerance test and calculated using a mathematical model. SI is a measure of tissue response to circulating insulin in the blood following glucose injection. A low SI signifies low insulin sensitivity and high SI represents high insulin sensitivity.

  8. Change in Homeostatic Model Assessment (HOMA) β-cell Function

    Time frame: Change at 3 months from baseline

    The homeostasis model assessment of β-cell function (HOMA-β) is an index of insulin secretory function derived from fasting plasma glucose and insulin concentrations. This will be assessed at baseline and 3 months to measure the change in Homeostatic model assessment (HOMA) β-cell function. (HOMA) β-cell function is a method used to quantify beta-cell function from fasting blood samples of insulin and glucose. Normal levels for (HOMA) β-cell function is 107 or more. Lower numbers mean higher risk of developing diabetes.

  9. Change in Homeostatic Model Assessment (HOMA) Insulin Resistance (IR)

    Time frame: Change at 3 months from baseline

    Homeostatic model assessment (HOMA) is a method for assessing β-cell function and insulin resistance (IR) from basal (fasting) glucose and insulin or C-peptide concentrations. This will be assessed at baseline and 3 months to measure the change in Homeostatic model assessment (HOMA) insulin resistance. HOMA IR is a method used to quantify insulin resistance from fasting blood samples of insulin and glucose. Normal levels for HOMA-IR is less than 2.0. Higher levels mean higher risk for developing diabetes.

  10. Change in Fasting Insulin Clearance (FIC)

    Time frame: Change at 3 months from baseline

    This will be assessed at baseline and 3 months to measure the change in fasting insulin clearance (FIC). FIC derived from fasting C-peptide to insulin ratio.

  11. Change in Glucose-stimulated Insulin Clearance (GSIC)

    Time frame: Change at 3 months from baseline

    This will be assessed through an IV Glucose Tolerance Test (IVGTT) conducted at baseline and 3 months to measure the change in glucose-stimulated insulin clearance (GSIC). GSIC derived from molar ratio of C-peptide to insulin area under curve (AUC) over first 20 min of IVGTT.

Secondary outcomes

  1. Measure Change in Serum Biomarkers Panel 1

    Time frame: Change at 3 months from baseline

    Systematic inflammation will be measured through change in serum biomarkers (Leptin, Lipocalin 2 (LCN2), plasminogen activator inhibitor-1 (PAI-1), Intact OCN) taken at baseline and 3 months.

  2. Measure Change in Serum Biomarkers Panel 2

    Time frame: Change at 3 months from baseline

    Systematic inflammation will be measured through change in serum biomarkers (Adiponectin, RBP4) taken at baseline and 3 months.

  3. Measure Change in Leptin:Adiponectin Ratio (LAR)

    Time frame: Change at 3 months from baseline

    Systematic inflammation will be measured through change in leptin:adiponectin ratio (LAR) taken at baseline and 3 months.

  4. Measure Change in Fibroblast Growth Factor-21 (FGF-21)

    Time frame: Change at 3 months from baseline

    Systematic inflammation will be measured through change in Fibroblast growth factor-21 (FGF-21) taken at baseline and 3 months.

  5. Measure Change in C-Reactive Protein (CRP)

    Time frame: Change at 3 months from baseline

    Systematic inflammation will be measured through change in C-Reactive Protein (CRP) taken at baseline and 3 months.

  6. Measure Change in Thiobarbituric Acid Reactive Substance (TBARS)

    Time frame: Change at 3 months from baseline

    Systematic inflammation will be measured through change in Thiobarbituric acid reactive substance (TBARS) taken at baseline and 3 months.

Sponsors and collaborators

Lead sponsor

Tulane University Health Sciences Center

Other

Registry information

Acronym: BIM

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Sep 11, 2014
Registry last updated
Jun 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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