Overview

This trial is active, not recruiting.

Conditions obesity, cardiovascular disease, hypertension, diabetes
Treatments nesiritide, saline
Phase phase 1
Sponsor Translational Research Institute for Metabolism and Diabetes, Florida
Collaborator Sanford-Burnham Medical Research Institute
Start date November 2013
End date December 2015
Trial size 48 participants
Trial identifier NCT01977859, TRIMDFH 472930

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose basic science
Arm
(Placebo Comparator)
Saline infusion
saline
(Active Comparator)
Nesiritide infused for 90 minute, initially at 0.5 pmol/kg/min and doubled every 15 minutes to achieve a target infusion rate of 1.0 pmol/kg/min, followed by a steady state infusion at the target rate for an additional 150 minutes (4 hours total).
nesiritide
(Active Comparator)
Nesiritide infused for 90 minute, initially at 0.5 pmol/kg/min and doubled every 15 minutes to achieve a target infusion rate of 2.0 pmol/kg/min, followed by a steady state infusion at the target rate for an additional 150 minutes (4 hours total).
nesiritide
(Active Comparator)
Nesiritide infused for 90 minute, initially at 0.5 pmol/kg/min and doubled every 15 minutes to achieve a target infusion rate of 4.0 pmol/kg/min, followed by a steady state infusion at the target rate for an additional 150 minutes (4 hours total).
nesiritide
(Active Comparator)
Nesiritide infused for 90 minute, initially at 0.5 pmol/kg/min and doubled every 15 minutes to achieve a target infusion rate of 8.0 pmol/kg/min, followed by a steady state infusion at the target rate for an additional 150 minutes (4 hours total).
nesiritide

Primary Outcomes

Measure
Difference in level of B-type Natriuretic Peptide (BNP)
time frame: Days -2, 7, 14

Secondary Outcomes

Measure
Differences in the expression of NPRC
time frame: Day 7
Determine whether short term infusion of rhBNP increases metabolic rate and/or fat oxidation
time frame: Day 7
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
time frame: Day 7
Difference in responses of lean and obese subjects
time frame: Days -2, 7, 14

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

Official title BNP Pharmacodynamics and Effects on Metabolism in Lean and Obese Subjects
Principal investigator Richard E. Pratley, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Translational Research Institute for Metabolism and Diabetes, Florida.