Effect of Nesiritide Infusion on Insulin Sensitivity in Healthy Obese Insulin Resistant Subjects (BNP3)

March 9, 2020 updated by: AdventHealth Translational Research Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32804
        • Translational Research Institute for Metabolism and Diabetes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Obese nondiabetic insulin resistant subjects- Panel A
IV nesiritide 3 pmol/kg/min or placebo for nesiritide
Drug: Continous IV infusion of Nesiritide
Nesiritide (fhBNP) administered by continuous IV infusion during 48 hours.
Drug: Hyperinsulinemic 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.
Drug: Placebo
48 hours of placebo.
ACTIVE_COMPARATOR: Obese nondiabetic insulin resistant subjects- Panel B
IV nesiritide 2 pmol/kg/min or placebo for nesiritide
Drug: Continous IV infusion of Nesiritide
Nesiritide (fhBNP) administered by continuous IV infusion during 48 hours.
Drug: Hyperinsulinemic 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.
Drug: Placebo
48 hours of placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IV infusion of nesiritide at a 3pmol/kg rate
Time Frame: 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.
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth Translational Research Institute

Investigators

  • Principal Investigator: Richard Pratley, MD, Translational Reseach institute for Metabolism and Diabetes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 13, 2017

Primary Completion (ACTUAL)

September 24, 2018

Study Completion (ACTUAL)

February 19, 2020

Study Registration Dates

First Submitted

July 18, 2017

First Submitted That Met QC Criteria

July 26, 2017

First Posted (ACTUAL)

July 31, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 10, 2020

Last Update Submitted That Met QC Criteria

March 9, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRIMDFH 1081082

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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