Text Size

TTA in Treatment of Diabetes and Dyslipidemia (TODDY)

This study has been completed.
Sponsor:
Collaborator:
University of Bergen
Information provided by:
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT00605787
First received: January 17, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted

January 17, 2008
January 17, 2008
January 2002
June 2003   (final data collection date for primary outcome measure)
Plasma lipids [ Time Frame: -28 days, baseline, 14 and 28 days of TTA ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Plasma glucose [ Time Frame: -28 days, baseline, 14 and 28 days of TTA ] [ Designated as safety issue: Yes ]
  • Safety blood parameters [ Time Frame: -28 days, baseline, 14 and 28 days of TTA ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
TTA in Treatment of Diabetes and Dyslipidemia
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.
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Type 2 Diabetes Mellitus
  • Dyslipidemia
Drug: Tetradecylthioacetic acid (TTA)
1000mg capsules once daily for 28 days
Active Comparator: Single group
Single group all treated similarly, outcome evaluated as changes within individuals during intervention
Intervention: Drug: Tetradecylthioacetic acid (TTA)
Løvås K, Røst TH, Skorve J, Ulvik RJ, Gudbrandsen OA, Bohov P, Wensaas AJ, Rustan AC, Berge RK, Husebye ES. Tetradecylthioacetic acid attenuates dyslipidaemia in male patients with type 2 diabetes mellitus, possibly by dual PPAR-alpha/delta activation and increased mitochondrial fatty acid oxidation. Diabetes Obes Metab. 2009 Apr;11(4):304-14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
December 2007
June 2003   (final data collection date for primary outcome measure)

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.
Male
30 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00605787
NSD18032, NSD18032, REKIII021.01, SLV01-1232
Yes
Professor Eystein S Husebye, University of Bergen
Haukeland University Hospital
University of Bergen
Principal Investigator: Eystein S Husebye, MD, PhD Haukeland University Hospital
Haukeland University Hospital
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP