|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
Emory University American Diabetes Association |
|---|---|
| Information provided by: | Emory University |
| ClinicalTrials.gov Identifier: | NCT00721617 |
Purpose
Our 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. We hypothesize that observed changes in blood pressure are the result of acute endothelial dysfunction, and/or increased activation of the autonomic nervous system. In addition, it is not known if increased FFAs by repeated oral fat load results in similar blood pressure than intravenous lipid infusion. Accordingly, we propose: 1) a systematic evaluation of the effects of increasing FFA levels on blood pressure and endothelial (vascular) function, and 2) determine the effects of comparable increases in FFA concentration via intravenous infusion of Intralipid or by repeated oral fat load on blood pressure, insulin resistance and endothelial dysfunction in obese subjects. This study has two parts.
| Condition | Intervention |
|---|---|
|
Diabetes Hypertension Obesity |
Drug: Intravenous Infusions with Intralipid 20%, normal saline and liquid fat Drug: Intravenous Infusions with Intralipid 20% |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Free Fatty Acids-Induced Hypertension, Endothelial Dysfunction, Inflammation, Insulin Resistance, and Autonomic Dysfunction in Lean and Obese Subjects |
| Estimated Enrollment: | 48 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
during 3 visits 12 lean subjects will be given separate 24 hour challenges with i.v. saline (control), i.v. Intralipid 20% solution at 20 mL/h (96 g/24 h), and oral fat load of 96 g/24 h. |
Drug: Intravenous Infusions with Intralipid 20%, normal saline and liquid fat
Research subjects will receive, in random order, a 24-hour intravenous (IV) infusion of Intralipid 20% at 20ml/hr (a fat solution), 24-hour IV infusion of normal saline, or an oral liquid fat diet every 4 hours for 24-hours.
|
|
2: Placebo Comparator
Twelve obese nondiabetic and normotensive subjects will be randomized to receive salsalate, carvedilol or placebo for 6 weeks (total of 36 subjects). Study subjects may be those who participated in Aim 1 or a second cohort of subjects. Subjects who participated in Aim 1 will be randomized following completion of baseline (Aim 1) studies. |
Drug: Intravenous Infusions with Intralipid 20%
Twelve obese nondiabetic and normotensive subjects will be randomized to receive salsalate, carvedilol or placebo for 6 weeks (total of 36 subjects). Study subjects may be those who participated in Aim 1 or a second cohort of subjects. Subjects who participated in Aim 1 will be randomized following completion of baseline (Aim 1) studies. |
In the first part of the study, a group of 12 obese and 12 lean nondiabetic, normotensive subjects will be admitted to the Grady Clinical Research Center (GCRC) on separate 3 occasions. Research subjects will receive, in random order, a 24-hour intravenous (IV) infusion of Intralipid 20ml/hr (a fat solution), 24-hour IV infusion of normal saline, or an oral liquid fat diet every 4 hours for 24-hours. The effect of increased FFAs on blood pressure and endothelial (vascular) function via intravenous infusion versus oral fat load therapy will be assessed. The fat load (IV vs. oral) that causes the largest effect on blood pressure and endothelial function will be used in the second portion of the protocol. In the second part of the study, a group of 36 obese normotensive (diabetic and nondiabetic) subjects will be admitted to the GCRC on 2 separate occasions for a randomized control trial. Study subjects will first be admitted to receive a fat load and then they will be randomly placed on either salsalate, carvedilol, or placebo for 6 weeks. After the 6-week intervention period, the subjects will be re-admitted to the GCRC to see if the intervention has any effect on improving blood pressure or endothelial function.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Guillermo Umpierrez, MD | 404.778.1665 | geumpie@emory.edu |
| Contact: Dawn Smiley, MD | 404.778.1664 | dsmiley@emory.edu |
| United States, Georgia | |
| Grady Memorial Hospital | Recruiting |
| Atlanta, Georgia, United States, 30303 | |
| Contact: Guillermo Umpierrez, MD 404-778-1665 geumpie@emory.edu | |
| Contact: Dawn Smiley, MD 404.778.1664 dsmiley@emory.edu | |
| Principal Investigator: | Guillermo Umpierrez, MD | Emory University |
More Information
| Responsible Party: | Emory University School of Medicine ( Guillermo Umpierrez, MD ) |
| Study ID Numbers: | e9277 |
| Study First Received: | June 26, 2008 |
| Last Updated: | August 25, 2009 |
| ClinicalTrials.gov Identifier: | NCT00721617 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Diabetes Hypertension Obesity |
|
Obesity Salicylsalicylic acid Diabetes Mellitus Vascular Diseases Sodium Salicylate Overweight Insulin Inflammation |
Body Weight Signs and Symptoms Nutrition Disorders Overnutrition Insulin Resistance Carvedilol Hypertension |
|
Body Weight Signs and Symptoms Obesity Pathologic Processes Vascular Diseases Nutrition Disorders |
Overweight Overnutrition Cardiovascular Diseases Inflammation Hypertension |
