N/A
Completed N=36
Free Fatty Acids-Induced Hypertension in Obese Subjects (Aim #2)
Source: ClinicalTrials.gov NCT02406586 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
May 2015
Primary outcomePrimary: Change in Systolic Blood Pressure. — 15.37; 10.04; 10.25 mmHg
Summary
The purpose of this study is to see if salsalate, an Nuclear factor-kappaB (NF-κB) mediated inflammation inhibitor, or carvedilol, an α- and β-blocker, will protect against free fatty acid induced hypertension, insulin resistance, endothelial dysfunction, inflammation and oxidative stress, and autonomic dysfunction in obese normotensive subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Systolic Blood Pressure. |
15.37; 10.04; 10.25 | — |
| PRIMARY Change in Systolic Blood Pressure |
11.23; 9.92; 3.04 | — |
| PRIMARY Change in Systolic Blood Pressure |
11.23; 9.92; 3.04 | — |
| PRIMARY Change in Systolic Blood Pressure |
11.23; 9.92; 3.04 | — |
| PRIMARY Change in Systolic Blood Pressure |
11.23; 9.92; 3.04 | — |
| PRIMARY Change in Systolic Blood Pressure |
11.23; 9.92; 3.04 | — |
| PRIMARY Change in Systolic Blood Pressure |
11.23; 9.92; 3.04 | — |
| PRIMARY Change in Systolic Blood Pressure |
11.23; 9.92; 3.04 | — |
| PRIMARY Change in Systolic Blood Pressure |
11.23; 9.92; 3.04 | — |
| PRIMARY Change in Systolic Blood Pressure |
11.23; 9.92; 3.04 | — |
| PRIMARY Change in Systolic Blood Pressure |
11.23; 9.92; 3.04 | — |
| PRIMARY Change in Systolic Blood Pressure |
11.23; 9.92; 3.04 | — |
| PRIMARY Change in Flow-mediated Dilation |
0.39; 0.70; 0.48 | — |
| PRIMARY Change in Flow-mediated Dilation |
0.39; 0.70; 0.48 | — |
| PRIMARY Change in Flow-mediated Dilation |
0.39; 0.70; 0.48 | — |
| PRIMARY Change in Flow-mediated Dilation |
0.39; 0.70; 0.48 | — |
| SECONDARY Change in Diastolic Blood Pressure From Baseline to 6 Weeks |
1.00; -1.50; 2.22 | — |
| SECONDARY Change in Oxidative Stress Markers. |
— | — |
| SECONDARY Change in Augmentation Index (AIx) |
— | — |
| SECONDARY Change in Expression of Inflammatory Biomarker Interleukin-6 (IL-6) |
-0.29; -1.84; -0.36 | — |
| SECONDARY Change in FFA (Free Fatty Acid) Levels From Baseline to 6 Weeks |
-0.08; 0.04; 0.03 | — |
| SECONDARY Change in Pulse Wave Velocity (PWV) |
— | — |
| SECONDARY Change in Expression of Inflammatory Biomarker C-Reactive Protein (CRP) |
2.55; -7.08; -0.20 | — |
Eligibility Criteria
Inclusion Criteria
- Males or females
- Obese subjects (body mass index (BMI) ≥ 30 kg/m^2)
- 18 and 65 years
- Blood pressure reading 250 mg/dL
- Liver disease (ALT 2.5x > upper limit of normal)
- Serum creatinine ≥1.5 mg/dL
- Smokers, drug or alcohol abuse
- Mental condition rendering the subject unable to understand the scope and possible consequences of the study
- Female subjects who are pregnant or breast feeding
Data sourced from ClinicalTrials.gov (NCT02406586). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.