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TTA in Treatment of Diabetes and Dyslipidemia

NCT ID: NCT00605787

Last Updated: 2008-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2007-12-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Type 2 Diabetes Mellitus Dyslipidemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single group

Single group all treated similarly, outcome evaluated as changes within individuals during intervention

Group Type ACTIVE_COMPARATOR

Tetradecylthioacetic acid (TTA)

Intervention Type DRUG

1000mg capsules once daily for 28 days

Interventions

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Tetradecylthioacetic acid (TTA)

1000mg capsules once daily for 28 days

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Bergen

OTHER

Sponsor Role collaborator

Haukeland University Hospital

OTHER

Sponsor Role lead

Responsible Party

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University of Bergen

Principal Investigators

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Eystein S Husebye, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Haukeland University Hospital

Locations

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Haukeland University Hospital

Bergen, Bergen, Norway

Site Status

Countries

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Norway

References

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Lovas K, Rost 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. doi: 10.1111/j.1463-1326.2008.00958.x.

Reference Type DERIVED
PMID: 19267708 (View on PubMed)

Other Identifiers

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NSD18032

Identifier Type: -

Identifier Source: secondary_id

REKIII021.01

Identifier Type: -

Identifier Source: secondary_id

SLV01-1232

Identifier Type: -

Identifier Source: secondary_id

NSD18032

Identifier Type: -

Identifier Source: org_study_id