Type 2 Diabetes MellitusPhase 2TODDYNCT00605787
TTA in Treatment of Diabetes and Dyslipidemia
A Phase 2 study testing Tetradecylthioacetic acid (TTA) in people with Type 2 Diabetes Mellitus and Dyslipidemia, run by Haukeland University Hospital at 1 site in Norway.
Trial 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 Read more about this study
- Who is it for?
- Ages 30 to 60 years, men only
- Conditions the study is for
- Type 2 Diabetes Mellitus, Dyslipidemia
- What is being tested?
- Tetradecylthioacetic acid (TTA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2002to Dec 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus, Dyslipidemia
- Being tested
- Tetradecylthioacetic acid (TTA)
- Medical subject headings
- Diabetes Mellitus, Type 2, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetradecylthioacetic acid (TTA)Drug
1000mg capsules once daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Single group | Active comparator | Single group all treated similarly, outcome evaluated as changes within individuals during intervention Receives: Drug: Tetradecylthioacetic acid (TTA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma lipids
Measured: -28 days, baseline, 14 and 28 days of TTA
Secondary outcomes (2)
Plasma glucose
Measured: -28 days, baseline, 14 and 28 days of TTA
Safety blood parameters
Measured: -28 days, baseline, 14 and 28 days of TTA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2008 (estimated)
- Study startJan 2002
- Primary completionJun 2003
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen
- Investigators
- Eystein S Husebye, MD, PhD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00605787
- Sponsor's protocol ID
- NSD18032
- Other IDs
- NSD18032, REKIII021.01, SLV01-1232
- Acronym
- TODDY
- Status last verified
- Jan 2008
- First submitted
- 17 Jan 2008
- Last updated
- 31 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19267708
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TTA in Treatment of Diabetes and Dyslipidemia
- ClinicalTrials.gov ID
- NCT00605787
- Acronym / sponsor ID
- TODDY / NSD18032
- Conditions
- Type 2 Diabetes Mellitus, Dyslipidemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- University of Bergen
- Study start
- Jan 2002
- Primary completion
- Jun 2003 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 31 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group | Active comparator | Drug: Tetradecylthioacetic acid (TTA)Single group all treated similarly, outcome evaluated as changes within individuals during intervention |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tetradecylthioacetic acid (TTA)1000mg capsules once daily for 28 days | Drug | Single group |
Primary outcome
Plasma lipids
Time frame: -28 days, baseline, 14 and 28 days of TTA
2 secondary outcomes
Plasma glucose
Time frame: -28 days, baseline, 14 and 28 days of TTA
Safety blood parameters
Time frame: -28 days, baseline, 14 and 28 days of TTA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2008.
- Derived from this study: PubMed 19267708Lovas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eystein S Husebye, MD, PhD principal investigator
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tetradecylthioacetic acid (TTA) in people with Type 2 Diabetes Mellitus and Dyslipidemia, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma lipids (time frame: -28 days, baseline, 14 and 28 days of TTA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00605787, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2008.