Clinical Trials

Inclusion Criteria:

• Males and females between 18 and 65 years of age.
• Able to comprehend instructions, follow study procedures.
• Willing to sign an informed consent form.
• Willing to consume an isoenergetic diet eating all meals from Mayo GCRC for at least 3 days prior to study.
• Overweight/Obese volunteers will have a BMI 29.0 – 40.0 kg/m^2:
• Upper body/visceral obesity (UBO) in women will be those with a waist-hip ratio (WHR) > 0.85 and/or increased visceral fat by single slice CT scan and/or biochemical evidence of metabolic syndrome. 
• Upper body obesity in men will be defined as a waist-hip ratio of > 0.95 and/or increased visceral fat by single slice CT scan and/or biochemical evidence of metabolic syndrome.
• Volunteers with Type 2 Diabetes will have HbA1C from 6.5-11.5%.
• Hold metformin and sulfonylurea for 1 week prior study.
• Avoid pioglitazone due to long half life.
• Resting vital signs are within the following range:
  • 95 mmHg < systolic blood pressure < 160 mmHg;
  • 45 mmHg < diastolic blood pressure < 100 mmHg;
  • 40 bpm < heart rate < 100 bpm;
  • Weight stable +0.3 kg for 2 months.
• Female subjects are eligible if they meet the following criteria:
  • Are not pregnant or nursing;
  • All women of childbearing potential will have a negative serum pregnancy test at screening and a negative urine pregnancy test within 48 hours before administering study drug;
  • All women of childbearing potential will use an appropriate contraceptive method including barrier method, oral contraceptive medication, contraceptive device or abstinence while participating in the study.
• Recent or current research participation:
  • If Yes look at consent form and f/u visits:
  • Medications that alter fat metabolism possibly given: if yes, exclude.
  • Weight possible changing in the study.
  • Amount of blood drawn during the study (if our study plus this one draw ≥ 450 ml these should be separated by 8 weeks.
  • Previous labs:
    • HbA1C < 6.5% for non-diabetic UBO;
    • Fasting glucose < 126 mg/dl for non-diabetic UBO;
    • Hb ≥ 11.0 for women and ≥ 12 for men;
    • Platelets > 100000.

Exclusion Criteria:

• Individuals with a history of a disease process such as:
  • Ischemic heart disease;
  • Atherosclerotic valvular disease.
  • Blood pressure greater than 160/95 despite antihypertensive medication.
• Smokers > 20 cigarettes per week.
• Concomitant use of medications that can alter serum lipid profile:
  • High dose fish;
  • il (> 3g per day);
  • STATINS (if yes hold for 6 weeks and receive PCP’s approval);
  • Niacin;
  • Fibrates;
  • Beta-blockers;
  • Atypical antipsychotics;
  • Antidepressants that cause weight gain if newly prescribed or not weight stable for 1 year;
• Allergy to Lidocaine, niacin and/or Niaspan;
• Subjects with any of the following parameters greater than 1.5 times the upper limit of normal:
  • Serum creatinine;
  • Alkaline phosphatase;
  • Aspartate aminotransferase (AST) unless participant has fatty liver disease, in which case AST can be < 2 times upper limit normal;
  • Alanine aminotransferase (ALT) unless participant has fatty liver disease, in which case AST can be < 2 times upper limit normal;
  • Total bilirubin (unless the patient has documented Gilbert’s syndrome).
• Subjects with any laboratory outside the normal range, unless determined by the investigator that the abnormality is not clinically significant for an obese or diabetic, but otherwise healthy subject.