Type 2 Diabetes Mellitus Clinical Trial
Official title:
TTA in Treatment of Diabetes and Dyslipidemia
The aim of the study is to evaluate the short-term effects of tetradecylthioacetic acid (TTA) on plasma lipids and glucose in male patients with type 2 diabetes mellitus and dyslipidemia
The tight linkage of obesity, insulin resistance (and frank diabetes), dyslipidemia, and
hypertension has been widely observed and has been named syndrome X, or the metabolic
syndrome. For many years metformin has been the only drug in clinical use with effects on
insulin resistance. Recently, agonists of the peroxisome proliferator-activated receptors
(PPARs) have been introduced in the treatment of type 2 diabetes. The different PPARs seem
to be activated by a wide range of lipids and lipid mediators, including fatty acids.
2-tetradecylthioacetic acid (TTA) is a modified fatty acid with high affinity for the
PPARgamma receptor. In animal models of obesity-related insulin resistance (obese Zucker
rats and dietary manipulated Wistar rats), TTA has an insulin sensitizing effect by
enhancing the insulin mediated uptake of glucose in peripheral tissues. TTA treatment
promotes fatty acid catabolism in experimental animals and this could casually be linked to
the improved glucose tolerance.
The protocol for the present study describes a safety assessment and therapeutic exploratory
evaluation of TTA in a small subset of male type 2 diabetes patients for 4 weeks. The
primary safety parameters will include general physical observational parameters, liver
function test and hematological parameters. To goal is to assess the efficacy of TTA on
selected metabolic parameters including fasting blood glucose and insulin, fasting plasma
lipids, antioxidant status, and fibrinolytic parameters, weight, BMI and blood pressure.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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