FFA Hypertension and Inflammation in Lean and Obese Subjects (FFAADA)

Emory University

Status: Completed

Conditions: Hypertension; Diabetes; Obesity

Treatments: Other: Oral fat load; Other: Normal Saline; Other: Intralipid 20%

Study type: Interventional

Funder types: Other

Identifiers

NCT00721617

IRB00009277

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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12 participants in 2 patient groups

Obese subjects

Active Comparator group

Description:

Obese normotensive subjects will receive 24 hour challenges on 3 separate occasions, in a random order, with IV Normal Saline at 20ml/hour, IV Intralipid (20% solution at 20 ml/hour and an oral fat load (96g/24 hours)

Treatment:

Other: Oral fat load

Other: Normal Saline

Other: Intralipid 20%

Lean subjects

Active Comparator group

Description:

Lean normotensive subjects will receive 24 hour challenges on 3 separate occasions, in a random order, with IV Normal Saline at 20ml/hour, IV Intralipid (20% solution at 20 ml/hour and an oral fat load (96g/24 hours)

Treatment:

Other: Oral fat load

Other: Normal Saline

Other: Intralipid 20%