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TTA in Treatment of Diabetes and Dyslipidemia (TODDY)

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ClinicalTrials.gov Identifier: NCT00605787
Recruitment Status : Completed
First Posted : January 31, 2008
Last Update Posted : January 31, 2008
Sponsor:
Collaborator:
University of Bergen
Information provided by:
Haukeland University Hospital

Brief 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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Dyslipidemia Drug: Tetradecylthioacetic acid (TTA) Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TTA in Treatment of Diabetes and Dyslipidemia
Study Start Date : January 2002
Actual Primary Completion Date : June 2003
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Plasma lipids [ Time Frame: -28 days, baseline, 14 and 28 days of TTA ]

Secondary Outcome Measures :
  1. Plasma glucose [ Time Frame: -28 days, baseline, 14 and 28 days of TTA ]
  2. Safety blood parameters [ Time Frame: -28 days, baseline, 14 and 28 days of TTA ]


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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: January 31, 2008    Key Record Dates
Last Update Posted: January 31, 2008
Last Verified: January 2008

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