Ensayos clínicos

Inclusion Criteria:

• Males and females over age 18-65 years.
• Able to comprehend instructions, follow study procedures.
• Willing to provide written, informed consent. The volunteers will consume an isoenergetic diet eating all meals from Mayo CRTU for 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 defined as those with a waist-hip ratio (WHR) > 0.85 and/or increased visceral fat by single slice CT scan, usually with > 120 cm^2 of visceral fat by CT scanning or a visceral fat/total fat ratio of > 0.30, and/or biochemical evidence of metabolic syndrome as defined by ATP III criteria (fasting plasma triglycerides ≥ 150 mg/dL, HDL-cholesterol < 50 mg/dL for women and < 40 mg/dL for men, fasting plasma glucose ≥ 100 mg/dL).  Upper body obesity in men will be defined as a waist-hip ratio of >0.95 and/or increased visceral fat (visceral fat area > 120 cm^2 or a visceral/total fat abdominal ratio by CT of > 0.40) by single slice CT scan and/or biochemical evidence of metabolic syndrome as defined by ATP III criteria. These visceral fat values are based upon the data collected at Mayo Clinic using our methods, and are correlated with dyslipidemia and hyperinsulinemia.
• Female subjects are eligible if they meet the following criteria:
  • Are not pregnant or nursing;
  • All women of childbearing potential will have a negative urine pregnancy test at screening and a negative urine pregnancy test day of admission for inpatient study visit;
  • 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. They will confirm use of one of these methods.

Exclusion Criteria:

• Individuals with a history of a disease process such as:
  • Ischemic heart disease;
  • Atherosclerotic valvular disease;
  • Persistent blood pressure greater than 160/95 despite antihypertensive medication;
  • Peripheral artery disease;
  • Any history of trans-ischemic attacks;
  • Coronary artery disease.;
  • Liver cirrhosis;
  • Significant renal impairment as documented in medical chart.
• Smokers.
• Diagnosis of Diabetes Mellitus.
• Concomitant use of medications that can alter free fatty acid metabolism or pose a drug-drug interaction:
  • Statins (if yes hold for 4 weeks and receive primary care provider’s approval);
  • Niacin;
  • Fibrates;
  • thiazolidinediones;
  • Beta-blockers;
  • Oral or injected corticosteroids or anabolic steroids;
  • Any history of use of pioglitazone;
  • Linezolid;
  • Dihydroergotamine;
  • Phenelzine;
  • Phosphodiesterase inhibitors.
• Allergy to lidocaine.
• Allergy to indocyanine green.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 12/28/23. Questions regarding updates should be directed to the study team contact.