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
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes Mellitus
Dyslipidemia
Drug: Tetradecylthioacetic acid (TTA)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: TTA in Treatment of Diabetes and Dyslipidemia

Resource links provided by NLM:


Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Plasma lipids [ Time Frame: -28 days, baseline, 14 and 28 days of TTA ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 16
Study Start Date: January 2002
Study Completion Date: December 2007
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Single group
Single group all treated similarly, outcome evaluated as changes within individuals during intervention
Drug: Tetradecylthioacetic acid (TTA)
1000mg capsules once daily for 28 days

Detailed 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.

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00605787

Locations
Norway
Haukeland University Hospital
Bergen, Norway, 5021
Sponsors and Collaborators
Haukeland University Hospital
University of Bergen
Investigators
Principal Investigator: Eystein S Husebye, MD, PhD Haukeland University Hospital
  More Information

No publications provided by Haukeland University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor Eystein S Husebye, University of Bergen
ClinicalTrials.gov Identifier: NCT00605787     History of Changes
Other Study ID Numbers: NSD18032, NSD18032, REKIII021.01, SLV01-1232
Study First Received: January 17, 2008
Last Updated: January 17, 2008
Health Authority: Norway: Norwegian Medicines Agency
Norway: Norwegian Social Science Data Services
Norway:National Committee for Medical and Health Research Ethics

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Dyslipidemias
Endocrine System Diseases
Glucose Metabolism Disorders
Lipid Metabolism Disorders
Metabolic Diseases
1-(carboxymethylthio)tetradecane
Antioxidants
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on October 23, 2014