Clinical trial NCT03234751: Effect of Nesiritide Infusion on Insulin Sensitivity in Healthy Obese Insulin Resistant Subjects
Official title: Effect of Nesiritide Infusion on Insulin Sensitivity in Healthy Obese Insulin Resistant Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Keywords: human B-type natriuretic peptide
Lead sponsor: AdventHealth Translational Research Institute
Sponsor class: OTHER
First posted: 2017-07-31
Enrollment: 6
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study is prospective randomized, double masked, 2-period cross over design, proof of concept study of the effects of intravenously administered rhBNP (nesiritide) on insulin sensitivity in otherwise healthy obese nondiabetic insulin resistant subjects.
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

1. Age 40-65 years inclusive
2. Men and women
3. Able to provide written, informed consent
4. Weight stable (± 3 kg) during the 3 months prior to enrollment
5. BMI ≥ 30 kg/m2; body weight ≤ 106 kg
6. Resting blood pressure ≥ 110/60 mmHg and ≤ 150/100 mmHg

Exclusion Criteria:

1. Known coronary artery disease, angina or heart failure
2. Type 1 or Type 2 Diabetes (A1c ≥ 6.5% and/or fasting plasma glucose \>125mg/dL)
3. Bleeding disorders
4. Hemoglobin level \< 12.5 g/dL for women; \< 13.0 g/dL for men
5. Acute or chronic infections
6. Hepatitis and/or cirrhosis (AST or Alanine Aminotransferase 2.5 times upper limit of normal)
7. Severe asthma or chronic obstructive pulmonary disease
8. Renal insufficiency (creatinine \> 1.6 mg/dL)
9. Prior bariatric surgery
10. Inflammatory bowel disease or malabsorption
11. Cancer within the last 3 years (except non-melanoma skin cancer or treated cervical carcinoma in situ)
12. Psychiatric or eating disorders
13. Untreated or inadequately controlled thyroid (abnormal TSH) or other endocrine disorders
14. Active rheumatoid arthritis or other inflammatory rheumatic disorder
15. Pregnant or nursing women
16. Presence of clinically significant abnormalities on electrocardiogram
17. Smoking (within the last 3 months)
18. Known hypersensitivity to nesiritide or any of its excipients
19. Poor intravenous access
20. 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.

Primary outcomes:
measure: IV infusion of nesiritide at a 3pmol/kg rate
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Translational Research Institute for Metabolism and Diabetes
state: Florida
Study officials:
affiliation: Translational Reseach institute for Metabolism and Diabetes
name: Richard Pratley, MD
role: PRINCIPAL_INVESTIGATOR
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