A Phase 2 interventional study of Tetradecylthioacetic acid (TTA) in Type 2 Diabetes Mellitus and Dyslipidemia, sponsored by Haukeland University Hospital. Completed at 1 site in Norway. Open to male participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2008-01-31.
Sponsored by Haukeland University Hospital · Phase 2, Interventional, and Treatment
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.
9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's enrollment of 16 is below the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
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Exclusion Criteria:
Single group all treated similarly, outcome evaluated as changes within individuals during intervention
Drug: Tetradecylthioacetic acid (TTA)
1000mg capsules once daily for 28 days
Plasma lipids
Time frame: -28 days, baseline, 14 and 28 days of TTA
Plasma glucose
Time frame: -28 days, baseline, 14 and 28 days of TTA
Safety blood parameters
Time frame: -28 days, baseline, 14 and 28 days of TTA
This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.
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