Clinical trial NCT00721617: FFA Hypertension and Inflammation in Lean and Obese Subjects
Official title: Free Fatty Acids-Induced Hypertension, Endothelial Dysfunction, Inflammation, Insulin Resistance, and Autonomic Dysfunction in Lean and Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Hypertension
Obesity
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
First posted: 2008-07-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed description: Recent studies indicate that increased levels of a circulating fat (free fatty acids or FFAs) increases blood pressure, impairs endothelial (vascular) function, and increases inflammatory markers in subjects with and without diabetes. The effects of FFA on blood pressure and vasculature have not been fully investigated. A group of 12 obese nondiabetic, normotensive subjects will be admitted to the Grady Clinical Research Center (GCRC) on separate 4 occasions. Research subjects will receive, in random order, a 8-hour intravenous (IV) infusion of Intralipid 20% at 40 mL/h (a fat solution), 8-hour IV infusion of normal saline at 40 mL/h, 8-hour IV infusion of dextrose (sugar) 10% at 40 mL/h, and a 8-hour intravenous (IV) infusion combination of Intralipid 20% and dextrose 10% at 40mL/h.

Eligibility criteria: Inclusion Criteria:

* Males or females
* Obese subjects (body mass index (BMI) ≥ 30 kg/m\^2)
* 18 and 65 years
* Blood pressure reading \< 140/80 mm Hg and no prior history of hypertension

Exclusion Criteria:

* History of diabetes mellitus
* History of hypertension
* Fasting triglyceride levels \> 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

Primary outcomes:
measure: Change in Flow-mediated Dilation From Baseline to 4 Hours
timeFrame: Baseline, 4 hours
measure: Change in Systolic Blood Pressure From Baseline to 4 Hours
timeFrame: Baseline, 4 hours
measure: Change in Systolic Blood Pressure From Baseline to 8 Hours
timeFrame: Baseline, 8 hours
measure: Change in Diastolic Blood Pressure From Baseline to 4 Hours
timeFrame: Baseline, 4 hours
measure: Change in Diastolic Blood Pressure From Baseline to 8 Hours
timeFrame: Baseline, 8 hours
Secondary outcomes:
measure: Change in FFA (Free Fatty Acid) Levels From Baseline to 4 Hours
timeFrame: Baseline, 4 hours
measure: Changes in FFA (Free Fatty Acid) Levels From Baseline to 8 Hours
timeFrame: Baseline, 8 hours
measure: Change in Triglyceride Levels From Baseline to 4 Hours
timeFrame: Baseline, 4 hours
measure: Change in Triglyceride Levels From Baseline to 8 Hours
timeFrame: Baseline, 8 hours
measure: Plasma Glucose Levels for Saline Infusion
timeFrame: Baseline, 4 hours, 8 hours
measure: Plasma Glucose Levels for Intralipid Infusion
timeFrame: Baseline, 4 hours, 8 hours
measure: Plasma Glucose Levels for Dextrose Infusion
timeFrame: Baseline, 4 hours, 8 hours
measure: Plasma Glucose Levels for Intralipid/Dextrose Infusion
timeFrame: Baseline, 4 hours, 8 hours
measure: Insulin Levels for Saline Infusion
timeFrame: Baseline, 4 hours, 8 hours
measure: Insulin Levels for Intralipid Infusion
timeFrame: Baseline, 4 hours, 8 hours
measure: Insulin Levels for Dextrose Infusion
timeFrame: Baseline, 4 hours, 8 hours
measure: Insulin Levels for Intralipid/Dextrose Infusion
timeFrame: Baseline, 4 hours, 8 hours
measure: C-peptides Levels for Saline Infusion
timeFrame: Baseline, 4 hours, 8 hours
measure: C-peptides Levels for Intralipid Infusion
timeFrame: Baseline, 4 hours, 8 hours
measure: C-peptides Levels for Dextrose Infusion
timeFrame: Baseline, 4 hours, 8 hours
measure: C-peptides Levels for Intralipid/Dextrose Infusion
timeFrame: Baseline, 4 hours, 8 hours
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Guillermo Umpierrez, MD
role: PRINCIPAL_INVESTIGATOR
References: