A Study Comparing the Effect of Niacin and Insulin on Splanchnic Bed Fatty Acid Spillover

Overview

About this study

The purpose of this study is to learn more about how the body stores dietary fat. Medical research has shown that fat stored in different parts of the body can affect the risk for diabetes, heart disease and other major health conditions.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Informed, written consent 
  • Normal blood pressure 
  • Non Diabetic 
  • Ages 30-65
  • BMI 25.1-40 kg/m2
  • Baseline lipid data to determine the presence or absence of atherogenic dyslipidemia
    • Will attempt to enroll those with fasting TGs >150 but < 400 mg/dL and/or HDL < 45 mg/dL in men, < 50 mg/dL in women with the final decision for enrollment based on the clinical judgement of the PI
  • The degree of insulin resistance will be confirmed during the screening phase by an OGTT with seven time points to measure glucose and insulin
  • age and gender matched healthy lean controls with a BMI ≤ 25.0 will be enrolled
    • The controls will have normal screening lipids 
    • The controls will be normotensive and will be on no chronic medications as noted above
  • The following screening labs, done either at a screening visit or documented in the medical record within the previous 3 months, will be within the normal range
    • CBC
    • AST
    • Creatinine
    • TSH
    • POC pregnancy test (day of screen and day of admission)
      • Women of reproductive capability will be enrolled but  radiation is used on the inpatient study day
    • Sexually active women who are able to become pregnant (i.e. intact uterus and menses within the past 1 year) must agree to use one of the birth control methods listed below
      • Hormonal methods such as birth control pills, patches, injections, vaginal ring, or implants
      • Barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm)
      • Intrauterine device (IUD)
      • Abstinence (no sex)

 

Exclusion Criteria

  • Individuals with diabetes or uncontrolled hypertension and those taking triglyceride-lowering agents (niacin) 
  • No chronic medications, especially any known to affect glucose and/or lipid metabolism, except oral contraceptives or antihistamines 
  • Must tolerate being given a stable diet 
  • Will not be involved in regular vigorous exercise 
  • Chronic health conditions other than allergies without asthma  
  • Abnormal lab results in any of the screening labs listed above.
  • Pregnancy
  • Known allergy or contraindication to niacin or insulin or to local anesthetics
  • Frequent use of alcohol (more than 1 ounce per day) or any use of recreational drugs
  • Inability or unwillingness to give written informed consent
    • For individuals who do not read and write in English, see DSMP for consent plan for subjects with English as a second language.
  • Subjects who have donated a unit of blood to a blood bank within 84 days
    • Subjects who have had a venipuncture within 84 days for other reasons than blood donation to a blood bank must not have exceeded removal of 550 mL of blood

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Rita Basu, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20164342

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