Effect of Nesiritide Infusion on Insulin Sensitivity in Healthy Obese Insulin Resistant Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03234751

Acronym

BNP3

Enrollment

Registered

2017-07-31

Start date

2017-07-13

Completion date

2020-02-19

Last updated

2020-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Keywords

human B-type natriuretic peptide

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.

Interventions

DRUGContinous IV infusion of Nesiritide

Nesiritide (fhBNP) administered by continuous IV infusion during 48 hours.

DRUGHyperinsulinemic euglycemic clamp

48 hours IV infusion of nesiritide on insulin sensitivity (IS) measured by two-step hyperinsulinemic euglycemic clamp in obese nondiabetic insulin resistant subjects.

DRUGPlacebo

48 hours of placebo.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

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.

Eligibility

Sex/Gender

ALL

Age

40 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
IV infusion of nesiritide at a 3pmol/kg rate	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026