FFA Hypertension and Inflammation in Lean and Obese Subjects

NCT00721617 | Completed Results DMC

• 1 other identifier: IRB00009277
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Hypertension; Obesity

Outcome Measures

Primary Outcomes (5)

• Change in Flow-mediated Dilation From Baseline to 4 Hours

  Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. FMD is expressed as the change in diameter from baseline to 4 hours.

  Baseline, 4 hours

• Change in Systolic Blood Pressure From Baseline to 4 Hours

  Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 4 hour systolic blood pressure from baseline systolic blood pressure.

  Baseline, 4 hours

• Change in Systolic Blood Pressure From Baseline to 8 Hours

  Systolic blood pressure is the amount of pressure your heart generates when pumping blood through your arteries to the rest of your body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 8 hour systolic blood pressure from baseline systolic blood pressure.

  Baseline, 8 hours

• Change in Diastolic Blood Pressure From Baseline to 4 Hours

  Diastolic blood pressure is the amount of pressure in your arteries when your heart is at rest between beats. Current guidelines identify normal diastolic blood pressure as lower than 80 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 4 hour diastolic blood pressure from baseline diastolic blood pressure.

  Baseline, 4 hours

• Change in Diastolic Blood Pressure From Baseline to 8 Hours

  Diastolic blood pressure is the amount of pressure in your arteries when your heart is at rest between beats. Current guidelines identify normal diastolic blood pressure as lower than 80 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 8 hour diastolic blood pressure from baseline diastolic blood pressure.

  Baseline, 8 hours

Secondary Outcomes (16)

• Change in FFA (Free Fatty Acid) Levels From Baseline to 4 Hours

  Baseline, 4 hours

• Changes in FFA (Free Fatty Acid) Levels From Baseline to 8 Hours

  Baseline, 8 hours

• Change in Triglyceride Levels From Baseline to 4 Hours

  Baseline, 4 hours

• Change in Triglyceride Levels From Baseline to 8 Hours

  Baseline, 8 hours

• Plasma Glucose Levels for Saline Infusion

  Baseline, 4 hours, 8 hours

Study Arms (2)

Obese subjects

ACTIVE COMPARATOR

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)

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

Lean subjects

ACTIVE COMPARATOR

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)

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

Interventions

Intralipid 20% 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.

Lean subjects; Obese subjects

Normal Saline OTHER

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

Lean subjects; Obese subjects

Oral fat load 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; Obese subjects

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• American Diabetes Association: collaborator

Study Sites (1)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension; Obesity

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

A larger sample size and inclusion of subjects from different ethnicities would be required to generalize the results of this study. Study used healthy volunteers--outcomes cannot be applied to patients with diabetes mellitus or insulin resistance

Results Point of Contact

• Title: Dr. Guillermo Umpierrez
• Organization: Emory University

geumpie@emory.edu

404-778-1665

Study Officials

• Guillermo Umpierrez, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 26, 2008
• First Posted: July 24, 2008
• Study Start: April 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: July 27, 2015
• Results First Posted: July 27, 2015

Record last verified: 2015-07

Locations

US (1)