Clinical trial NCT01977859: BNP Pharmacodynamics and Effects on Metabolism in Lean and Obese Subjects
Official title: BNP Pharmacodynamics and Effects on Metabolism in Lean and Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Cardiovascular Disease
Hypertension
Diabetes
Keywords: B-type Natriuretic Peptide
Metabolism
Insulin infusion
Lead sponsor: AdventHealth Translational Research Institute
Sponsor class: OTHER
Collaborators: name: Sanford-Burnham Medical Research Institute
First posted: 2013-11-07
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to collect data to help researchers better understand the various causes of obesity, which may lead to the development of new obesity treatment options.

Detailed description: Obesity is major metabolic health concern and the potential beneficial effects of natriuretic peptides, specifically B-type natriuretic peptide (BNP) on adipocyte biology, energy expenditure and body weight could be of great significance. This study will provide insight into the mechanisms of dysregulation of the natriuretic peptides system in obesity and will contribute to delineate the roles and the clinical importance of BNP in the treatment of obesity.

Eligibility criteria: Inclusion Criteria:

* Age 18-65 years, inclusive
* Men and women
* Able to provide written, informed consent
* Weight stable (± 3 kg) during the 3 months prior to enrollment
* BMI ≤ 25 kg/m2 for lean subjects or ≥ 30 kg/m2 for obese subjects

Exclusion Criteria:

* 1) Diagnosed with any of the following co-morbidities: a) coronary artery disease, angina or heart failure, b) diabetes, c) bleeding disorders, d) infections, e) hepatitis and/or cirrhosis, f) severe asthma or Chronic obstructive pulmonary disease (COPD), g) renal insufficiency, h) bariatric surgery, i) inflammatory bowel disease or malabsorption, j) cancer within the last 3 years (except non-melanoma skin cancer or treated cervical carcinoma in situ), k) psychiatric or eating disorders, l) untreated or inadequately controlled thyroid or other endocrine disorders, m) active rheumatoid arthritis or other inflammatory rheumatic disorder
* Pregnant or nursing women
* Presence of clinically significant abnormalities on electrocardiogram;
* Smoking
* 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 COX-2 inhibitors, g) other drugs known to affect immune or metabolic function and h) orlistat, phentermine or other weight loss or anorectic agents.
* Your blood pressure at your screening visit is less than or equal to 100/60 or greater than or equal to 160/100.

Primary outcomes:
measure: Difference in level of B-type Natriuretic Peptide (BNP)
timeFrame: Days -2, 7, 14
Secondary outcomes:
measure: Differences in the expression of NPRC
timeFrame: Day 7
measure: Determine whether short term infusion of rhBNP increases metabolic rate and/or fat oxidation
timeFrame: Day 7
measure: determine whether short term infusion of rhBNP alters gene expression in subcutaneous adipose tissue and skeletal muscle in a pattern consistent with activation of thermogenic pathways
timeFrame: Day 7
measure: Difference in responses of lean and obese subjects
timeFrame: Days -2, 7, 14
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Translational Research Institute for Metabolism and Diabetes
state: Florida
Study officials:
affiliation: AdventHealth
name: Richard E. Pratley, MD
role: PRINCIPAL_INVESTIGATOR
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