N/A
N=13
FFA-Induced Hypertension and Endothelial Dysfunction
Endothelial Dysfunction · Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00589888 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcome: Primary: Change in Systolic Blood Pressure to After Completing an 8-hour Normal Saline Infusion in Obese Normotensive Subjects. — 13 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intralipid 20% @ 20cc/hour (Drug); Intralipid 20%@ 40cc/hour (Drug); Normal Saline (Drug); 32-gram oral fat load (Dietary_supplement); 64-gram oral fat load (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Systolic Blood Pressure to After Completing an 8-hour Normal Saline Infusion in Obese Normotensive Subjects. |
13 | — |
| PRIMARY Change in Systolic Blood Pressure From Baseline to After Completing an 8-hour 20% Intralipid @ 20cc/hr Infusion in Obese Normotensive Subjects. |
14 | — |
| PRIMARY Changes in Systolic Blood Pressure From Baseline to After Completing an 8-hour 20% Intralipid @ 40cc/hr Infusion in Obese Normotensive Subjects |
12 | — |
| PRIMARY Change in Systolic Blood Pressure From Baseline to After Completing an Oral 32-gram Fat Load in Obese Normotensive Subjects. |
13 | — |
| PRIMARY Changes in Systolic Blood Pressure From Baseline to After Completing an Oral 64-gram Fat Load in Obese Normotensive Subjects |
11 | — |
| SECONDARY Change in Flow-mediated Dilation (FMD) of Endothelium-dependent Brachial Artery From Baseline to After Completing a Specific Intervention in Obese Normotensive Subjects. |
3.8; 4.1; 0.3; 3.8; 5 | — |
| SECONDARY Change in Blood Glucose Levels From Baseline to 6-8 Hours After Intervention Among Obese Healthy Subjects |
93.9; 92.3; 91.5; 91.5; 87.1; 84.2 | — |
| SECONDARY Change in C-peptide Concentration Levels From Baseline to After Specific Intervention Among the Healthy Obese Subjects |
1.64; 2.06; 1.95; 2.02; 2.5; 2.1 | — |
| SECONDARY Change in Blood Insulin Levels From Baseline to After Intervention Among the Normal Obese Subjects |
8.5; 9.2; 8.8; 7.8; 9.1; 8.6 | — |
Summary
The study is a prospective open label study to examine the effects of oral and intravenous fat load on blood pressure, endothelial function, sympathetic activity, and oxidative stress in obese healthy subjects. Subjects will receive either 8-hour of intravenous or oral fat loads in either low or high doses or normal saline in random order. Blood samples are drawn and vitals are measured before and after the infusions. Endothelial function and plasma glucose and lipid levels are measured to study the effects.
Eligibility Criteria
Inclusion Criteria
- Males or females between the ages of 18 and 65 years.
- Definition: obese = BMI ≥ 30 kg/m2
- Blood pressure 250 mg/dL during the stabilization period.
- Liver disease (ALT 2.5x > upper limit of normal), or other significant medical or surgical illness, including myocardial ischemia, congestive heart failure, liver failure, and infectious processes.
- Serum creatinine ≥1.5 mg/dL for males, or ≥ 1.4 mg/dL for females.
- History of drug or alcohol abuse within the last 5 years.
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- Female subjects are pregnant or breast feeding at time of enrollment into the study.
Data sourced from ClinicalTrials.gov (NCT00589888). 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.