A Study Comparing the Effect of Niacin and Insulin on Splanchnic Bed Fatty Acid Spillover
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Rochester, Minnesota: 13-008002
Sponsor Protocol Number: 13-008002
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.
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.
- 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
- 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)
- 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.
- 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
Mayo Clinic principal investigator
Rita Basu, M.D.
Closed for enrollment
Publications are currently not available