TTA in Treatment of Diabetes and Dyslipidemia (TODDY)

January 17, 2008 updated by: Haukeland University Hospital
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway, 5021
        • Haukeland University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma lipids
Time Frame: -28 days, baseline, 14 and 28 days of TTA
-28 days, baseline, 14 and 28 days of TTA

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma glucose
Time Frame: -28 days, baseline, 14 and 28 days of TTA
-28 days, baseline, 14 and 28 days of TTA
Safety blood parameters
Time Frame: -28 days, baseline, 14 and 28 days of TTA
-28 days, baseline, 14 and 28 days of TTA

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haukeland University Hospital

Collaborators

University of Bergen

Investigators

  • Principal Investigator: Eystein S Husebye, MD, PhD, Haukeland University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (Actual)

June 1, 2003

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

January 17, 2008

First Submitted That Met QC Criteria

January 17, 2008

First Posted (Estimate)

January 31, 2008

Study Record Updates

Last Update Posted (Estimate)

January 31, 2008

Last Update Submitted That Met QC Criteria

January 17, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSD18032
  • REKIII021.01
  • SLV01-1232

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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