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Production of Free Fatty Acids From Blood Triglycerides

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00911482
Recruitment Status : Completed
First Posted : June 2, 2009
Last Update Posted : November 7, 2012
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
Mayo Clinic

Tracking Information
First Submitted Date May 29, 2009
First Posted Date June 2, 2009
Last Update Posted Date November 7, 2012
Study Start Date June 2008
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 1, 2009)
Spillover of free fatty acids from chylomicrons [ Time Frame: Measured at 1 to 6 days ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Production of Free Fatty Acids From Blood Triglycerides
Official Title FFA Production From Triglyceride-Rich Lipoproteins
Brief Summary The overall hypothesis of these studies is that circulating triglycerides, coming primarily from fat in the diet, are an important source of free fatty acids. Free fatty acids are the major fat fuel in the body, and when they are elevated in the blood they are thought to raise the risk of cardiovascular disease by causing insulin resistance (in some cases leading to diabetes), raising blood pressure, and other effects. The investigator will use sophisticated methods for tracing triglycerides and free fatty acids in the blood. These methods involve the administration of low doses of radioactive and stable isotopes of naturally occurring fats. The studies will determine the contribution of triglycerides to free fatty acids in normal people and also in people with diabetes.
Detailed Description Lipid energy is transported in the blood in several forms, including chylomicrons and free fatty acids (FFA). Chylomicrons are key elements in the absorption and storage of dietary fat, and also play a role in the pathogenesis of atherosclerosis via the production of remnant particles, but their role as a direct fuel source has not been explored. FFA are the major lipid fuel in the body, and increases in their concentration have been shown to cause insulin resistance, endothelial dysfunction and increases in the production of very low density lipoproteins. FFA are released into the blood through the action of hormone sensitive lipase on triglyceride stores in fat cells. Very little is known about the role of chylomicrons in FFA metabolism, but the potential contribution of chylomicrons to FFA is considerable, especially in people who consume high fat diets. Initial studies indicate that in addition to the role of chylomicrons in fat storage, a portion of chylomicron fatty acids are released as FFA in a process called "spillover". These studies indicate that the contribution of chylomicrons to FFA is increased in type 2 diabetes. A study of spillover in the splanchnic bed found very high rates of splanchnic spillover in overweight and obese individuals with hypertriglyceridemia. Extremely accurate and precise methods have been developed by the investigator for the measurement of the concentration and specific activity of FFA and chylomicron triglyceride fatty acids in plasma. In addition, a tracer method for accurately determining the kinetics of chylomicrons has been developed. In the proposed studies, the tracer technique will be used to systematically investigate the contribution of chylomicrons to total FFA availability. The technique will be applied to normal subjects at rest and after exercise, as well as subjects with type 2 diabetes mellitus and hypertriglyceridemia. Specifically, these studies will: 1) determine whether weight loss in people with type 2 diabetes reduces spillover from chylomicrons; 2) determine whether acute lowering of FFA with insulin infusion reduces spillover in nondiabetic individuals with dyslipidemia; 3) determine whether noninsulin-mediated lowering of FFA reduces spillover in diabetic individuals with dyslipidemia, and 4) determine whether obese, insulin-resistant individuals have increased spillover in the splanchnic bed.
Study Type Observational
Study Design Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Plasma samples obtained during the study are stored for lipid analysis.
Sampling Method Probability Sample
Study Population Volunteers from the region around Rochester, Minnesota who meet the inclusion criteria will be recruited.
Condition
  • Diabetes Mellitus, Type 2
  • Insulin Resistance
  • Dyslipidemias
Intervention Not Provided
Study Groups/Cohorts
  • Diabetes/weight loss
    12 individuals with type 2 diabetes and hypertriglyceridemia
  • Nondiabetic/hypertriglyceridemic
    10 insulin resistant nondiabetic individuals with dyslipidemia
  • Normotensive/nondiabetic
    10 insulin resistant, normotensive, nondiabetic individuals
  • Insulin resistant/dyslipidemic
    14 insulin resistant nondiabetic individuals with dyslipidemia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 6, 2012)
16
Original Estimated Enrollment
 (submitted: June 1, 2009)
53
Actual Study Completion Date January 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Type 2 diabetes
  • Atherogenic dyslipidemia
  • Obesity

Exclusion Criteria:

  • Kidney disease
  • Liver disease
  • Coronary artery disease
  • Retinopathy
  • Neuropathy
Sex/Gender
Sexes Eligible for Study: All
Ages 35 Years to 60 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00911482
Other Study ID Numbers 08-001493
R01HL067933 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party John M. Miles, MD, Mayo Foundation
Original Responsible Party Same as current
Current Study Sponsor Mayo Clinic
Original Study Sponsor National Heart, Lung, and Blood Institute (NHLBI)
Collaborators National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: John M. Miles, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date November 2012