N/A N=12 Randomized Single-blind Basic Science

FFA Hypertension and Inflammation in Lean and Obese Subjects

Diabetes · Hypertension · Obesity

Bottom Line

View on ClinicalTrials.gov: NCT00721617 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2015

Primary outcome: Primary: Change in Flow-mediated Dilation From Baseline to 4 Hours — 0.16; -3.2; -0.9; -2.4 percent change in diameter

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Intralipid 20% (Other); Normal Saline (Other); Oral fat load (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Emory University
Primary completion: Jun 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Flow-mediated Dilation From Baseline to 4 Hours	0.16; -3.2; -0.9; -2.4	—
PRIMARY Change in Systolic Blood Pressure From Baseline to 4 Hours	1.92; 12.58; 3.00; 1.91	—
PRIMARY Change in Systolic Blood Pressure From Baseline to 8 Hours	0.33; 12.08; 2.58; 12.9	—
PRIMARY Change in Diastolic Blood Pressure From Baseline to 4 Hours	-1.25; 6.2; -2.08; -4.27	—
PRIMARY Change in Diastolic Blood Pressure From Baseline to 8 Hours	1.2; 4.8; -0.83; 2.7	—
SECONDARY Change in FFA (Free Fatty Acid) Levels From Baseline to 4 Hours	-0.05; 0.84; -0.13; -0.11	—
SECONDARY Changes in FFA (Free Fatty Acid) Levels From Baseline to 8 Hours	0.03; 1.03; -0.18; -0.1	—
SECONDARY Change in Triglyceride Levels From Baseline to 4 Hours	-0.83; 118.9; -4.99; 39.6	—
SECONDARY Change in Triglyceride Levels From Baseline to 8 Hours	2.1; 121.1; 3.98; 47.3	—
SECONDARY Plasma Glucose Levels for Saline Infusion	86.0; 87.0; 88.0	—
SECONDARY Plasma Glucose Levels for Intralipid Infusion	78.4; 75.6; 73.7	—
SECONDARY Plasma Glucose Levels for Dextrose Infusion	77.4; 100.4; 93.0	—
SECONDARY Plasma Glucose Levels for Intralipid/Dextrose Infusion	71.6; 101.2; 97.8	—
SECONDARY Insulin Levels for Saline Infusion	8.4; 11.3; 10.1	—
SECONDARY Insulin Levels for Intralipid Infusion	9.1; 11.3; 9.3	—
SECONDARY Insulin Levels for Dextrose Infusion	8.4; 25.1; 33.4	—
SECONDARY Insulin Levels for Intralipid/Dextrose Infusion	10.4; 28.0; 40.5	—
SECONDARY C-peptides Levels for Saline Infusion	2.21; 2.06; 2.71	—
SECONDARY C-peptides Levels for Intralipid Infusion	2.14; 2.39; 2.40	—
SECONDARY C-peptides Levels for Dextrose Infusion	1.96; 4.73; 5.79	—
SECONDARY C-peptides Levels for Intralipid/Dextrose Infusion	2.23; 4.97; 6.43	—

Summary

Although a large number of obese patients develop high blood pressure, the cause is unknown. The purpose of this study is to look at the effect of high fatty acids (a type of fat) in the development of high blood pressure in obese people.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00721617). 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.