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

Overview

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Rita Basu, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available
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CLS-20164342

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