TTA in Treatment of Diabetes and Dyslipidemia

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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TTA in Treatment of Diabetes and Dyslipidemia

Conditions
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Type 2 Diabetes Mellitus, Dyslipidemia

Intervention / Treatment
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* Drug: Tetradecylthioacetic acid (TTA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: type 2 diabetes mellitus with HbA1c 8.0-12.0%, fasting S-triacylglycerol 2.0-10.0 mmol/L, body mass index 25-40 kg/m2 and/or waist/hip ratio > 0.90. Exclusion Criteria: fasting total cholesterol >10 mmol/L, blood pressure 170/110 mmHg other significant disease Use of any corticosteroid, anticoagulant or lipid-lowering drug 2 weeks prior to inclusion.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single group<br>Single group all treated similarly, outcome evaluated as changes within individuals during intervention | Drug: Tetradecylthioacetic acid (TTA)<br>* 1000mg capsules once daily for 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma lipids |  | -28 days, baseline, 14 and 28 days of TTA | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma glucose |  | -28 days, baseline, 14 and 28 days of TTA | 
| Safety blood parameters |  | -28 days, baseline, 14 and 28 days of TTA |