Status:
COMPLETED
Effects of Niacin on Intramyocellular Fatty Acid Trafficking in Upper Body Obesity and Type 2 Diabetes Mellitus
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type 2 Diabetes Mellitus
Obesity
Eligibility:
All Genders
18-55 years
Phase:
EARLY_PHASE1
Brief Summary
Muscle insulin resistance is a hallmark of upper body obesity (UBO) and Type 2 diabetes (T2DM). It is unknown whether muscle free fatty acid (FFA) availability or intramyocellular fatty acid trafficki...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Women and Men (Women premenopausal)
- BMI 29-37
- Weight stable
- Not pregnant/nursing
- Exclusion criteria:
- Ischemic heart disease
- Atherosclerotic valvular disease
- Smokers (\>20 cigarettes per week)
- Bilateral oophorectomy
- Concomitant use of medications that can alter serum lipid profile:
- High dose fish oil (\>3g per day),
- STATINS (if yes hold for 6 weeks and receive PCP's approval),
- Niacin
- Fibrates
- thiazolidinediones
- Beta-blockers
- Atypical antipsychotics
- Lidocaine or Niacin/Niaspan allergy
- Subjects with 1.5 times upper limit of normal of serum creatinine, Alkaline phosphatase, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) unless participant has fatty liver disease, Total bilirubin (unless the patient has documented Gilbert's syndrome)
Exclusion
Key Trial Info
Start Date :
November 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03867500
Start Date
November 1 2018
End Date
December 22 2021
Last Update
January 17 2025
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905