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Trial record 3 of 809 for:    APOB

The Association of SAA With Apolipoprotein B Affects Cardiovascular Risk

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ClinicalTrials.gov Identifier: NCT02770872
Recruitment Status : Completed
First Posted : May 12, 2016
Last Update Posted : March 29, 2018
Sponsor:
Collaborator:
VA Office of Research and Development
Information provided by (Responsible Party):
Lisa Tannock, University of Kentucky

Brief Summary:
Cardiovascular disease (CVD) is the leading cause of death in developed nations and a major health issue in Veterans. Despite a number of different treatments, cardiovascular disease remains a major health burden, thus further treatments are needed. Individuals with obesity and/or diabetes are at particularly high risk for cardiovascular disease, and research suggests that elevated levels of serum amyloid A (SAA) may contribute to cardiovascular disease, particularly atherosclerosis. In preliminary studies in both mouse and human the investigators have identified that SAA appears to shift between lipid particles. SAA is mainly found on high density lipoprotein (HDL) particles; however, the investigators have found that in both mice and humans with obesity and/or diabetes SAA is found on low density lipoprotein (LDL) and very low density lipoprotein (VLDL) particles, and the investigators hypothesize that the presence of SAA on LDL or VLDL makes these particles more likely to cause cardiovascular disease. To determine what leads SAA to shift between lipid particles, SAA knockout mice will be injected with HDL containing SAA then blood collected at several time points over 24 hours, and the lipid particles will be isolated to measure SAA. In some experiments the investigators will compare different isoforms of SAA, different types of HDL particles, or induce expression of enzymes likely involved in shifting SAA between particles. To determine if the presence of SAA makes lipid particles bind vascular matrix more strongly, the investigators will collect carotid arteries and compare the extent of lipid particles bound to the vascular matrix in the vessel wall when the particles have or do not have SAA present. If this research confirms this hypothesis then the presence of SAA on LDL or VLDL may 1) be a new marker indicating humans at highest risk for cardiovascular disease and 2) be a new target of therapy to prevent cardiovascular disease.

Condition or disease Intervention/treatment
Cardiovascular Disease Other: Observation of SAA on apoB containing lipoproteins

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 19 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: The Association of SAA With Apolipoprotein B Affects Cardiovascular Risk
Study Start Date : February 2014
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : February 28, 2018

Group/Cohort Intervention/treatment
Obese, normal
Approximately 25 subjects aged 50-75 with BMI's between 27-45 kg/m2. Observation of SAA on apoB containing lipoproteins
Other: Observation of SAA on apoB containing lipoproteins
attempting to elicit the conditions by which SAA shifts from apo-A1 containing lipoproteins to apoB containing lipoproteins

Obese, MetS
Approximately 25 subjects aged 50-75 with BMI's between 27-45 kg/m2, blood pressure above 135/80, HDL less than 40 mg/dl, triglycerides greater the 150 mg/dl and fasting blood glucose greater than 100 mg/dl but less than 126 mg/dl. Observation of SAA on apoB containing lipoproteins
Other: Observation of SAA on apoB containing lipoproteins
attempting to elicit the conditions by which SAA shifts from apo-A1 containing lipoproteins to apoB containing lipoproteins

Obese, diabetic
Approximately 25 subjects aged 50-75 with BMI's between 27-45 kg/m2 and physician diagnosed diabetes mellitis. Observation of SAA on apoB containing lipoproteins
Other: Observation of SAA on apoB containing lipoproteins
attempting to elicit the conditions by which SAA shifts from apo-A1 containing lipoproteins to apoB containing lipoproteins




Primary Outcome Measures :
  1. Post-prandial SAA content on apoB containing lipoproteins after consumption of a high fat shake [ Time Frame: Baseline and once every hour for 8 hours. Study completed in a single day ]
    Subjects will arrive at the clinic fasted and have an IV line established. A baseline blood sample will be drawn at hour zero. The subject will then consume a high fat shake within a 15 minute window. Blood samples will then be drawn every hour for eight hours to determine the time course of SAA shifting from HDL to apoB containing lipoproteins.

  2. Degree of insulin resistance [ Time Frame: 4.5 hour study completed in a single day ]
    Subjects will arrive at the clinic fasted. The subject will have IV sites established in both arms and two baseline blood samples will be drawn (-30 and -10 minute). At time zero, a bolus of glucose will be injected followed by blood sample collection. Blood will be collected at the following time points in minutes; 0, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 19. At time 20 minutes, the subject will receive an IV bolus of insulin and frequent blood sampling will continue at the following time points in minutes; 20, 22, 23, 24, 25, 27, 30, 40, 50, 70, 90, 100, 120, 140 ,160, 180, 210, 240. A total of 32 blood samples will be collected over the course of 4.5 hours.


Biospecimen Retention:   Samples With DNA
Whole blood will be collected, which will contain DNA


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study will recruit male and female subjects eligible for medical care within the VA healthcare system
Criteria

Inclusion Criteria:

Up to 80 U.S. veterans age 50-75 will be recruited in the following three groups:

  • Obese (BMI 27-45 kg/m2), metabolically healthy, (25-30 subjects)
  • Obese (BMI 27-45 kg/m2), metabolic syndrome, (25-30 subjects)
  • Obese (BMI 27-45 kg/m2), diabetic, (25-30 subjects)

Exclusion Criteria:

The use of:

  • Statins (we will not exclude subjects on lipid lowering medications if they are willing to discontinue them for 1-2 weeks prior to participation)
  • Fibrates
  • Niacin
  • Anti-inflammatory drugs including Thiazolidinediones, non-steroidal anti-inflammatories (NSAID), aspirin, steroids
  • Estrogen replacement

Conditions such as:

  • Acute illness
  • Chronic inflammatory illness (such as psoriasis, rheumatoid arthritis, lupus, etc.)
  • Infections
  • Impaired renal function (eGFR < 60 ml/min)
  • Hypo- or hyperthyroidism (subjects biochemically euthyroid on levothyroxine therapy are permitted)
  • Gastrointestinal dysfunction

Lifestyles including:

  • Use of tobacco products
  • Consumption of > 3 drinks /day

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02770872


Locations
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United States, Kentucky
VA Medical Center
Lexington, Kentucky, United States, 40515
Sponsors and Collaborators
Lisa Tannock
VA Office of Research and Development
Investigators
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Principal Investigator: Lisa R Tannock, MD VA Medical System

Publications:

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Responsible Party: Lisa Tannock, Sponsor/PI, University of Kentucky
ClinicalTrials.gov Identifier: NCT02770872     History of Changes
Other Study ID Numbers: TAN-14-002-HAF
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Lisa Tannock, University of Kentucky:
serum amyloid a
lipoprotein
insulin resistance
dyslipidemia
Additional relevant MeSH terms:
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Cardiovascular Diseases