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Effects of Niacin on Intramyocellular Fatty Acid Trafficking in Upper Body Obesity and Type 2 Diabetes Mellitus

Overview

Información sobre este estudio

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 trafficking is responsible for the abnormal response to insulin. Likewise, we do not understand to what extent the incorporation of FFA into ceramides or diacylglycerols (DG) affect insulin signaling and muscle glucose uptake. We will measure muscle FFA storage into intramyocellular triglyceride, intramyocellular fatty acid trafficking, activation of the insulin signaling pathway and glucose disposal rates under both saline control (high overnight FFA) and after an overnight infusion of intravenous niacin (lower/normal FFA) to provide the first integrated examination of the interaction between FFA and muscle insulin action from the whole body to the cellular/molecular level. By identifying which steps in the insulin signaling pathway are most affected, we will determine the site-specific effect of ceramides and/or DG on different degrees of insulin resistance.
Hypothesis 1: Greater trafficking of plasma FFA into intramyocellular DG will impair proximal insulin signaling and reduce muscle glucose uptake.
Hypothesis 2: Lowering FFA in UBO and T2DM by using an intravenous infusion of niacin will alter trafficking of plasma FFA into intramyocellular ceramides in a way that will improve insulin signaling and increase muscle glucose uptake.
Hypothesis 3: Lowering FFA in UBO and T2DM by using an intravenous infusion of niacin will alter trafficking of plasma FFA into intramyocellular DG in a way that will improve insulin signaling and increase muscle glucose uptake.

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:

- 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)

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

Eligibility last updated 6/9/23. Questions regarding updates should be directed to the study team contact.

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 Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Michael Jensen, M.D.

Cerrado para la inscripción

Contact information:

Pamela Reich

(507) 255-6062

Reich.Pamela@mayo.edu

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20432035

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