TTA in Treatment of Diabetes and Dyslipidemia

Type 2 Diabetes Mellitus Clinical Trial

— TODDY  

Official title:

TTA in Treatment of Diabetes and Dyslipidemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00605787
• Other study ID #: NSD18032
• Secondary ID: NSD18032REKIII02
• Status: Completed
• Phase: Phase 2
• First received: January 17, 2008
• Last updated: January 17, 2008
• Start date: January 2002
• Est. completion date: December 2007

Study information

• Verified date: January 2008
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines AgencyNorway: Norwegian Social Science Data ServicesNorway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2007
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 60 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Dyslipidemia
• Dyslipidemias
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Tetradecylthioacetic acid (TTA)
1000mg capsules once daily for 28 days

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen

Sponsors (2)

Lead Sponsor	Collaborator
Haukeland University Hospital	University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma lipids		-28 days, baseline, 14 and 28 days of TTA	No
Secondary	Plasma glucose		-28 days, baseline, 14 and 28 days of TTA	Yes
Secondary	Safety blood parameters		-28 days, baseline, 14 and 28 days of TTA	Yes