Effect of Nesiritide Infusion on Insulin Sensitivity in Healthy Obese Insulin Resistant Subjects
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Diabetes
- Sponsor
- AdventHealth Translational Research Institute
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- IV infusion of nesiritide at a 3pmol/kg rate
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The purpose of the study is to compare the effects of nesiritide to placebo administered by a continuous IV infusion over 48 hours for the treatment of insulin resistance in healthy, obese, insulin resistant individuals.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 40-65 years inclusive
- •Men and women
- •Able to provide written, informed consent
- •Weight stable (± 3 kg) during the 3 months prior to enrollment
- •BMI ≥ 30 kg/m2; body weight ≤ 106 kg
- •Resting blood pressure ≥ 110/60 mmHg and ≤ 150/100 mmHg
Exclusion Criteria
- •Known coronary artery disease, angina or heart failure
- •Type 1 or Type 2 Diabetes (A1c ≥ 6.5% and/or fasting plasma glucose \>125mg/dL)
- •Bleeding disorders
- •Hemoglobin level \< 12.5 g/dL for women; \< 13.0 g/dL for men
- •Acute or chronic infections
- •Hepatitis and/or cirrhosis (AST or Alanine Aminotransferase 2.5 times upper limit of normal)
- •Severe asthma or chronic obstructive pulmonary disease
- •Renal insufficiency (creatinine \> 1.6 mg/dL)
- •Prior bariatric surgery
- •Inflammatory bowel disease or malabsorption
Arms & Interventions
Obese nondiabetic insulin resistant subjects- Panel B
IV nesiritide 2 pmol/kg/min or placebo for nesiritide
Intervention: Placebo
Obese nondiabetic insulin resistant subjects- Panel A
IV nesiritide 3 pmol/kg/min or placebo for nesiritide
Intervention: Continous IV infusion of Nesiritide
Obese nondiabetic insulin resistant subjects- Panel A
IV nesiritide 3 pmol/kg/min or placebo for nesiritide
Intervention: Hyperinsulinemic euglycemic clamp
Obese nondiabetic insulin resistant subjects- Panel A
IV nesiritide 3 pmol/kg/min or placebo for nesiritide
Intervention: Placebo
Obese nondiabetic insulin resistant subjects- Panel B
IV nesiritide 2 pmol/kg/min or placebo for nesiritide
Intervention: Continous IV infusion of Nesiritide
Obese nondiabetic insulin resistant subjects- Panel B
IV nesiritide 2 pmol/kg/min or placebo for nesiritide
Intervention: Hyperinsulinemic euglycemic clamp
Outcomes
Primary Outcomes
IV infusion of nesiritide at a 3pmol/kg rate
Time Frame: 48 hours
Average changes in glucose disposal rates (GDR) and endogenous glucose production (EGP) from baseline corrected for body weight at steady state of the clamp during the high- and low-dose portions.