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

Diabetes Clinical Trial

— BNP3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03234751
• Other study ID #: TRIMDFH 1081082
• Status: Completed
• Phase: Phase 1
• Start date: July 13, 2017
• Est. completion date: February 19, 2020

Study information

• Verified date: March 2020
• Source: Translational Research Institute for Metabolism and Diabetes, Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: February 19, 2020
• Est. primary completion date: September 24, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Insulin Resistance

Intervention

Drug:
• Continous IV infusion of Nesiritide
Nesiritide (fhBNP) administered by continuous IV infusion during 48 hours.
• 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.
• Placebo
48 hours of placebo.

Locations

Country	Name	City	State
United States	Translational Research Institute for Metabolism and Diabetes	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Translational Research Institute for Metabolism and Diabetes, Florida

Country where clinical trial is conducted

United States, 

References & Publications (23)

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* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IV infusion of nesiritide at a 3pmol/kg rate	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