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

Sponsor
AdventHealth Translational Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT03234751
Collaborator
(none)
6
Enrollment
1
Location
2
Arms
31.2
Actual Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Continous IV infusion of Nesiritide
  • Drug: Hyperinsulinemic euglycemic clamp
  • Drug: Placebo
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
This study is prospective randomized, double masked, 2-period cross over design, proof of concept study of the effects of intravenously administered rhBNP (nesiritide) on insulin sensitivity in otherwise healthy obese nondiabetic insulin resistant subjects.This study is prospective randomized, double masked, 2-period cross over design, proof of concept study of the effects of intravenously administered rhBNP (nesiritide) on insulin sensitivity in otherwise healthy obese nondiabetic insulin resistant subjects.
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
Effect of Nesiritide Infusion on Insulin Sensitivity in Healthy Obese Insulin Resistant Subjects
Actual Study Start Date :
Jul 13, 2017
Actual Primary Completion Date :
Sep 24, 2018
Actual Study Completion Date :
Feb 19, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. IV infusion of nesiritide at a 3pmol/kg rate [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Translational Research Institute for Metabolism and Diabetes Orlando Florida United States 32804

Sponsors and Collaborators

  • AdventHealth Translational Research Institute

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
AdventHealth Translational Research Institute
ClinicalTrials.gov Identifier:
NCT03234751
Other Study ID Numbers:
  • TRIMDFH 1081082
First Posted:
Jul 31, 2017
Last Update Posted:
Mar 10, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by AdventHealth Translational Research Institute
human B-type natriuretic peptide
Additional relevant MeSH terms:
Insulin Resistance
Natriuretic Peptide, Brain

Study Results

No Results Posted as of Mar 10, 2020