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Sponsors and Collaborators: |
Haukeland University Hospital University of Bergen |
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Information provided by: | Haukeland University Hospital |
ClinicalTrials.gov Identifier: | NCT00605787 |
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 |
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Type 2 Diabetes Mellitus Dyslipidemia |
Drug: Tetradecylthioacetic acid (TTA) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | TTA in Treatment of Diabetes and Dyslipidemia |
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 |
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Single group: Active Comparator
Single group all treated similarly, outcome evaluated as changes within individuals during intervention
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Drug: Tetradecylthioacetic acid (TTA)
1000mg capsules once daily for 28 days
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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.
Ages Eligible for Study: | 30 Years to 60 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Norway | |
Haukeland University Hospital | |
Bergen, Norway, 5021 |
Principal Investigator: | Eystein S Husebye, MD, PhD | Haukeland University Hospital |
Responsible Party: | University of Bergen ( Professor Eystein S Husebye ) |
Study ID Numbers: | NSD18032, NSD18032, REKIII021.01, SLV01-1232 |
Study First Received: | January 17, 2008 |
Last Updated: | January 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00605787 |
Health Authority: | Norway: Norwegian Medicines Agency; Norway: Norwegian Social Science Data Services; Norway: The National Committees for Research Ethics in Norway |
Metabolic Diseases Diabetes Mellitus, Type 2 1-(carboxymethylthio)tetradecane Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Dyslipidemias Lipid Metabolism Disorders |
Antioxidants Molecular Mechanisms of Pharmacological Action Free Radical Scavengers |
Physiological Effects of Drugs Protective Agents Pharmacologic Actions |