Obesity Clinical Trial
Official title:
Natriuretic Peptides and Metabolic Risk in Obesity
Verified date | October 2017 |
Source | Vanderbilt University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators are examining:
1. the relationships of insulin levels and natriuretic peptide hormone levels, and
2. the effects of administering an infusion of natriuretic peptide hormone on the breakdown
of fat
in healthy lean and otherwise healthy obese individuals.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | February 2017 |
Est. primary completion date | February 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Men and women ages 18-50 years - BMI 18 to <25 kg/m2 (lean group, N=20) or BMI 30 to <40 kg/m2 (obese group, N=20) Exclusion Criteria: - Current use of antihypertensive medications - Current use of glucocorticoids, metformin, or any antidiabetes medications - Prior or current cardiovascular disease, renal disease, or liver disease - Diabetes mellitus (taking insulin, other anti-diabetic agents, or diet-controlled) - Atrial fibrillation - Bleeding disorder or anemia - Elevated LFTs - estimuated GFR < 60 ml/min - Abnormal sodium or potassium level - Positive pregnancy test, women of child-bearing age not practicing birth control, women who are breastfeeding |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University Medical Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in plasma renin activity | 4 hours (during 2-hour study infusions and for 2 hours after study infusions) | ||
Other | Change in aldosterone | 4 hours (during 2-hour study infusions and for 2 hours after study infusions) | ||
Primary | Change in natriuretic peptide levels | 4 hours (during 2-hour study infusions and for 2 hours after study infusions) | ||
Primary | Change in glycerol levels | Change during 1-hour of low-dose BNP infusion, 1-hour of high-dose BNP infusion, and 1-hour of normal saline infusion | 1 hour | |
Secondary | Change in free fatty acid levels | Change during 1-hour of low-dose BNP infusion, 1-hour of high-dose BNP infusion, and 1-hour of normal saline infusion | 1 hour | |
Secondary | Change in triglyceride levels | Change during 1-hour of low-dose BNP infusion, 1-hour of high-dose BNP infusion, and 1-hour of normal saline infusion | 1 hour | |
Secondary | Change in energy expenditure assessed by indirect calorimetry | Change during 1-hour of low-dose BNP infusion, 1-hour of high-dose BNP infusion, and 1-hour of normal saline infusion | 1 hour |
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