| Outcome Measures: |
Primary: Change From Baseline in Insulin Sensitivity as Measured by Glucose Infusion Rate (GIR), Insulin sensitivity was measured the morning after an overnight fast during an in-patient stay in the Clinical Research Unit \& was determined by the mean GIR necessary to maintain euglycemia during a hyperinsulinemic (1.5 mcIU/kg of FFM per minute)-euglycemic (85-95 mg/dL) clamp. The clamp is an 8 hour process where a hand vein is catheterized to collect blood samples and intravenous lines are used to infuse glucose, saline, insulin, phenylalanine and amino acid solutions at at pre-specified times/rates. The mean GIR was calculated as the rate per kilograms of fat-free mass (FFM) during 4 hours of steady-state (hours 4-8 of the 8 hour clamp) reported as micromols/kilogram of FFM per minute. The FFM was measured by dual-energy x-ray absorptiometry (DEXA) scan. Insulin was infused with 5% essential amino acid solution (3mL/kg of FFM/hour) to prevent the insulin-dependent decrease of amino acids during insulin infusion., Baseline, 3 months | Secondary: Change From Baseline in Fasting Blood Glucose Level, Glucose (sugar) was measured in the blood and reported in milligrams per deciliter (mg/dL)., Baseline, 3 months|Change From Baseline in Glycosylated Hemoglobin (HbA1c), HbA1c is a measure of average blood sugar levels over the preceding 3 month period. HbA1c was measured by ion-exchange chromatography and reported as a percentage., Baseline, 3 months|Change From Baseline in Insulin Levels, Insulin levels in the blood were measured by immunoenzymatic assay and reported in micro International Units per milliliter (mcIU/mL)., Baseline, 3 months|Change From Baseline in Lipid Profile, Change in lipids were measured by the change from baseline to 3 months of triglycerides, high-density lipoprotein cholesterol (HDL-C) and non-high-density lipoprotein cholesterol (non-HDL-C). All were reported in milligrams/deciliter (mg/dL)., Baseline, 3 months|Change From Baseline in the Thrombotic Biomarker Fibrinogen, Fibrinogen was measured by thrombin clotting rate assay (Beckman Coulter, Inc. Brea, California) and reported in milligrams/deciliter (mg/dL)., Baseline, 3 months|Change From Baseline in the Thrombotic Biomarker Plasminogen Activator Inhibitor-1 (PAI-1), PAI-1 was measured by enzyme-linked immunosorbent assay (Diagnostica Stago Inc., Parsippany, New Jersey) and reported in nanograms per milliliter (ng/mL)., Baseline, 3 months|Change From Baseline in the Inflammatory Biomarker Interleukin 6 (IL-6), IL-6 is an inflammatory cytokine and reported in picograms per deciliter (pg/dL)., Baseline, 3 months|Change From Baseline in the Inflammatory Biomarker C-Reactive Protein (CRP), CRP is an inflammatory cytokine and is reported in milligrams per deciliter (mg/dL)., Baseline, 3 months|Change From Baseline in Inflammatory Biomarker Tumor Necrosis Factor-alpha (TNF-α), TNF-α is an inflammatory cytokine and is reported in picograms/milliliter (pg/mL)., Baseline, 3 month|Change From Baseline in the Inflammatory Biomarker Adiponectin, Adiponectin is an anti-inflammatory cytokine and is reported in milligrams per milliliter (mg/mL)., Baseline, 3 months | Other: Change From Baseline in Body Mass Index, Body Mass Index (BMI) is a health index for comparing weight to height. BMI is a person's weight in kilograms (kg) divided by his or her height in meters squared. The body mass index is an indication if a person is at a suitable weight for his height on an approximation of body fat., Baseline, 3 months|Change From Baseline in Body Fat, Body fat is reported as a percentage of body weight., Baseline, 3 months|Change From Baseline in Fat-Free Mass (FFM), FFM was measured using dual energy x-ray absorptiometry (DEXA) scans and is reported in kilograms (kg)., Baseline, 3 months
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