TTA in Treatment of Diabetes and Dyslipidemia (TODDY)

Haukeland University Hospital

Status and phase

Completed

Phase 2

Conditions

Type 2 Diabetes Mellitus

Dyslipidemia

Treatments

Drug: Tetradecylthioacetic acid (TTA)

Study type

Interventional

Funder types

Other

Identifiers

NCT00605787

NSD18032

REKIII021.01

SLV01-1232

Details and patient eligibility

About

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

Full description

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.

Enrollment

16 patients

Sex

Male

Ages

30 to 60 years old

Volunteers

No Healthy Volunteers

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.