Status:
COMPLETED
Effect of Nesiritide Infusion on Insulin Sensitivity in Healthy Obese Insulin Resistant Subjects
Lead Sponsor:
AdventHealth Translational Research Institute
Conditions:
Diabetes
Eligibility:
All Genders
40-65 years
Phase:
PHASE1
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 re...
Eligibility Criteria
Inclusion
- 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
- 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
- Cancer within the last 3 years (except non-melanoma skin cancer or treated cervical carcinoma in situ)
- Psychiatric or eating disorders
- Untreated or inadequately controlled thyroid (abnormal TSH) or other endocrine disorders
- Active rheumatoid arthritis or other inflammatory rheumatic disorder
- Pregnant or nursing women
- Presence of clinically significant abnormalities on electrocardiogram
- Smoking (within the last 3 months)
- Known hypersensitivity to nesiritide or any of its excipients
- Poor intravenous access
- Use of medications: a) nitrates, b) beta-blockers, c) digoxin, d) anti-diabetic agents, e) oral, injected or chronic topical steroids (inhaled steroids for mild asthma are acceptable), f) chronic use of aspirin or other non-steroidal anti-inflammatory drugs, including cyclooxygenase-2 inhibitors, g) other drugs known to affect immune or metabolic function and h) orlistat, phenteramine or other weight loss or anorectic agents.
Key Trial Info
Start Date :
July 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 19 2020
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03234751
Start Date
July 13 2017
End Date
February 19 2020
Last Update
March 10 2020
Active Locations (1)
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1
Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, United States, 32804