Effect of Nesiritide Infusion on Insulin Sensitivity in Healthy Obese Insulin Resistant Subjects
NCT ID: NCT03234751
Last Updated: 2020-03-10
Study Results
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Basic Information
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COMPLETED
PHASE1
6 participants
INTERVENTIONAL
2017-07-13
2020-02-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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Obese nondiabetic insulin resistant subjects- Panel A
IV nesiritide 3 pmol/kg/min or placebo for nesiritide
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.
Obese nondiabetic insulin resistant subjects- Panel B
IV nesiritide 2 pmol/kg/min or placebo for nesiritide
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
40 Years
65 Years
ALL
Yes
Sponsors
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AdventHealth Translational Research Institute
OTHER
Responsible Party
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Principal Investigators
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Richard Pratley, MD
Role: PRINCIPAL_INVESTIGATOR
Translational Reseach institute for Metabolism and Diabetes
Locations
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Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, United States
Countries
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References
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Other Identifiers
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TRIMDFH 1081082
Identifier Type: -
Identifier Source: org_study_id
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