FFA Hypertension and Inflammation in Lean and Obese Subjects

NCT ID: NCT00721617

Last Updated: 2015-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2011-06-30

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.

Conditions

Diabetes; Hypertension; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Obese subjects

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)

Group Type: ACTIVE_COMPARATOR

Intralipid 20%

Intervention Type: OTHER

Lean and obese normotensive subjects will receive Intralipid 20% infusion. Intralipid is an oil-in-water emulsion derived from egg phospholipids, soybean, and glycerol. The Intralipid 20% long-chain triglyceride emulsion contains: 200 g of soy bean oil; 12 g of egg yolk; 25 g of glycerol. The emulsion is composed of the following free fatty acids (FFAs): linoleic acid: 50%, oleic acid: 26%, palmitic acid: 10%, stearic acid: 9%, egg yolk, phospholipids: 3.5% It will be given intravenously at 20 ml/hr (96 g/24 h) for 24 hours.

Normal Saline

Intervention Type: OTHER

Lean and obese normotensive subjects will receive normal saline at 20 ml/hr for 24 hours.

Oral fat load

Intervention Type: OTHER

Lean and obese normotensive subjects will receive an oral fat load at 96 g/24hr. The oral liquid fat load will be given in equal amounts (16 g) every 4 hours (total 96 g over 24 hours).

Lean subjects

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)

Group Type: ACTIVE_COMPARATOR

Intralipid 20%

Intervention Type: OTHER

Lean and obese normotensive subjects will receive Intralipid 20% infusion. Intralipid is an oil-in-water emulsion derived from egg phospholipids, soybean, and glycerol. The Intralipid 20% long-chain triglyceride emulsion contains: 200 g of soy bean oil; 12 g of egg yolk; 25 g of glycerol. The emulsion is composed of the following free fatty acids (FFAs): linoleic acid: 50%, oleic acid: 26%, palmitic acid: 10%, stearic acid: 9%, egg yolk, phospholipids: 3.5% It will be given intravenously at 20 ml/hr (96 g/24 h) for 24 hours.

Normal Saline

Intervention Type: OTHER

Lean and obese normotensive subjects will receive normal saline at 20 ml/hr for 24 hours.

Oral fat load

Intervention Type: OTHER

Lean and obese normotensive subjects will receive an oral fat load at 96 g/24hr. The oral liquid fat load will be given in equal amounts (16 g) every 4 hours (total 96 g over 24 hours).

Interventions

Intralipid 20%

Lean and obese normotensive subjects will receive Intralipid 20% infusion. Intralipid is an oil-in-water emulsion derived from egg phospholipids, soybean, and glycerol. The Intralipid 20% long-chain triglyceride emulsion contains: 200 g of soy bean oil; 12 g of egg yolk; 25 g of glycerol. The emulsion is composed of the following free fatty acids (FFAs): linoleic acid: 50%, oleic acid: 26%, palmitic acid: 10%, stearic acid: 9%, egg yolk, phospholipids: 3.5% It will be given intravenously at 20 ml/hr (96 g/24 h) for 24 hours.

Intervention Type: OTHER

Normal Saline

Lean and obese normotensive subjects will receive normal saline at 20 ml/hr for 24 hours.

Intervention Type: OTHER

Oral fat load

Lean and obese normotensive subjects will receive an oral fat load at 96 g/24hr. The oral liquid fat load will be given in equal amounts (16 g) every 4 hours (total 96 g over 24 hours).

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Diabetes Association

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Guillermo Umpierrez

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guillermo Umpierrez, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Grady Memorial Hospital

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

IRB00009277

Identifier Type: -

Identifier Source: org_study_id