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

Completed · Phase 1 · Has a placebo group

Conditions studied: Diabetes

In brief

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.

Key facts

Study ID

NCT03234751

Run by

AdventHealth Translational Research Institute

People needed

6

Starts

2017-07-13

Expected to finish

2020-02-19

Last updated by the study team

2020-03-10

Who can join

Age: 40 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Translational Research Institute for Metabolism and Diabetes — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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