| Registry | NCT03234751, acronym BNP3 |
|---|---|
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional; randomized, crossover, masking: double, basic science |
| Enrollment | 6 (Actual) |
| Sponsor | AdventHealth Translational Research Institute (Other) |
| Conditions | Diabetes |
| Interventions | Continous IV infusion of Nesiritide, Hyperinsulinemic euglycemic clamp, Placebo (Drug) |
| Dates | start 2017-07-13, primary completion 2018-09-24, completion 2020-02-19, first posted 2017-07-31, last updated 2020-03-10 |
| Locations | 1 site in United States |
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All trials for Diabetes All trials of Continous IV infusion of Nesiritide All trials of Hyperinsulinemic euglycemic clamp
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Obese nondiabetic insulin resistant subjects- Panel A | Active comparator | Drug: Continous IV infusion of Nesiritide; Drug: Hyperinsulinemic euglycemic clamp; Drug: Placebo | IV nesiritide 3 pmol/kg/min or placebo for nesiritide |
| Obese nondiabetic insulin resistant subjects- Panel B | Active comparator | Drug: Continous IV infusion of Nesiritide; Drug: Hyperinsulinemic euglycemic clamp; Drug: Placebo | IV nesiritide 2 pmol/kg/min or placebo for nesiritide |
Sex: All, ages: 40 Years to 65 Years, accepts healthy volunteers
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Translational Research Institute for Metabolism and Diabetes | Orlando, Florida | United States |