Glucose Metabolism DisordersPhase 4NCT00306826
Pioglitazone in Impaired Glucose Tolerance
A Phase 4 study testing pioglitazone, simvastatin and pioglitazone + simvastatin in people with Glucose Metabolism Disorders, run by University of Leipzig at 7 sites in Germany.
Trial summary
In patients with impaired glucose tolerance (IGT), the researchers want to study the relative effects of pioglitazone, simvastatin, or the combination of both on: intima media thickness (IMT) as an easily assessed marker of atherosclerosis heart rate variability (HRV) as a marker of autonomic neuropathy flow-mediated… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Glucose Metabolism Disorders
- What is being tested?
- pioglitazone, simvastatin and pioglitazone + simvastatin
- How many people
- 120 participants
- Where
- 7 sitesGermany
- Study dates
- Start not givento May 2009
- Phase
- Phase 4
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Impaired glucose tolerance
- Age 40 to 75 years
Who cannot join
- Diabetes mellitus type 1 or 2
- Hypersensitivity to study medication
- Malignant tumor
- Alcohol or drug abuse
- Overt heart failure
- Severe hepatic, renal, neurological, psychiatric, or hematological disease
- Prior treatment with glitazones or statins
- Established indication for statin treatment (e.g. coronary artery disease [CAD])
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Germany7 sites
Praxis Antje Horn
Gera, 07548
Praxis Gunter Kässner
Leipzig, 04229
Praxis Heidrun Täschner
Leipzig, 04249
Praxis Martin Schönauer
Leipzig, 04275
University of Leipzig Heart Center
Leipzig, 04289
Praxis Matthias Weissbrodt
Leipzig, 04299
Praxis Matthias Schreiner
Leipzig, 04357
About this study
Official title: Effect of Pioglitazone on Intima Media Thickness, Endothelial Function, and Heart Rate Variability in Patients With Impaired Glucose Tolerance
In patients with impaired glucose tolerance (IGT), the researchers want to study the relative effects of pioglitazone, simvastatin, or the combination of both on:
- intima media thickness (IMT) as an easily assessed marker of atherosclerosis
- heart rate variability (HRV) as a marker of autonomic neuropathy
- flow-mediated vasodilatation (FMD) of the brachial artery as a marker of endothelial function
- vascular and metabolic lab parameters
Read the detailed description
We want to study the relative effects of pioglitazone, simvastatin or the combination of both on intima media thickness (IMT), heart rate variability (HRV), flow-mediated vasodilatation (FMD) of the brachial artery and vascular/metabolic lab parameters in patients with impaired glucose tolerance (IGT). Previous studies have shown a reduction in IMT for both pioglitazone and simvastatin in type 2 diabetics. Many patients with diabetes mellitus develop diabetic polyneuropathy which can be assessed by measuring HRV. It has been shown that pioglitazone has a positive effect on HRV in type 2 diabetics. Questions remain on the relative efficacy of pioglitazone and simvastatin on the parameters mentioned above. Also, there is only scarce data in patients with IGT (as opposed to overt diabetes mellitus). There are no data on the relative effects of pioglitazone and simvastatin on flow-mediated vasodilatation (FMD) of the brachial artery as a surrogate marker for endothelial function.
- Conditions
- Glucose Metabolism Disorders
- Being tested
- pioglitazone, simvastatin, pioglitazone + simvastatin
- Keywords
- Impaired glucose tolerance
- Medical subject headings
- Glucose Metabolism Disorders, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pioglitazoneDrug
simvastatinDrug
pioglitazone + simvastatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intima media thickness of carotid artery
Secondary outcomes (3)
Heart rate variability
Flow-mediated dilatation of brachial artery
Vascular/metabolic lab parameters
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2006 (estimated)
- Study completionMay 2009
Why it stopped: financial support withdrawn
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 Glucose Metabolism DisordersStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Collaborators
- Institut für Gesundheits- und Praxismanagement GmbH
- Investigators
- Gerhard Schuler, MD, Study chair, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00306826
- Sponsor's protocol ID
- Leipzig-01
- Status last verified
- Jun 2008
- First submitted
- 23 Mar 2006
- Last updated
- 2 Feb 2010
- Results posted
- No
Publications
Ipsen EO, Madsen KS, Chi Y, Pedersen-Bjergaard U, Richter B, Metzendorf MI, Hemmingsen B. Pioglitazone for prevention or delay of type 2 diabetes mellitus and its associated complications in people at risk for the development of type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 19;11(11):CD013516. doi: 10.1002/14651858.CD013516.pub2.
PubMed 33210751
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pioglitazone on Intima Media Thickness, Endothelial Function, and Heart Rate Variability in Patients With Impaired Glucose Tolerance
- ClinicalTrials.gov ID
- NCT00306826
- Acronym / sponsor ID
- Leipzig-01
- Conditions
- Glucose Metabolism Disorders
- Keywords
- Impaired glucose tolerance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: financial support withdrawn
- Enrolment
- 120 participants
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Collaborators
- Institut für Gesundheits- und Praxismanagement GmbH
- Study completion
- May 2009
- First posted
- 24 Mar 2006 (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.
In patients with impaired glucose tolerance (IGT), the researchers want to study the relative effects of pioglitazone, simvastatin, or the combination of both on:
- intima media thickness (IMT) as an easily assessed marker of atherosclerosis
- heart rate variability (HRV) as a marker of autonomic neuropathy
- flow-mediated vasodilatation (FMD) of the brachial artery as a marker of endothelial function
- vascular and metabolic lab parameters
Detailed description
We want to study the relative effects of pioglitazone, simvastatin or the combination of both on intima media thickness (IMT), heart rate variability (HRV), flow-mediated vasodilatation (FMD) of the brachial artery and vascular/metabolic lab parameters in patients with impaired glucose tolerance (IGT). Previous studies have shown a reduction in IMT for both pioglitazone and simvastatin in type 2 diabetics. Many patients with diabetes mellitus develop diabetic polyneuropathy which can be assessed by measuring HRV. It has been shown that pioglitazone has a positive effect on HRV in type 2 diabetics. Questions remain on the relative efficacy of pioglitazone and simvastatin on the parameters mentioned above. Also, there is only scarce data in patients with IGT (as opposed to overt diabetes mellitus). There are no data on the relative effects of pioglitazone and simvastatin on flow-mediated vasodilatation (FMD) of the brachial artery as a surrogate marker for endothelial function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Impaired glucose tolerance
- Age 40 to 75 years
Key exclusion criteria (8 listed)
- Diabetes mellitus type 1 or 2
- Hypersensitivity to study medication
- Malignant tumor
- Alcohol or drug abuse
- Overt heart failure
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 |
|---|---|---|
| pioglitazone | Drug | – |
| simvastatin | Drug | – |
| pioglitazone + simvastatin | Drug | – |
Primary outcome
Change in intima media thickness of carotid artery
3 secondary outcomes
Heart rate variability
Flow-mediated dilatation of brachial artery
Vascular/metabolic lab parameters
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2010.
- Derived from this study: PubMed 33210751Ipsen EO, Madsen KS, Chi Y, Pedersen-Bjergaard U, Richter B, Metzendorf MI, Hemmingsen B. Pioglitazone for prevention or delay of type 2 diabetes mellitus and its associated complications in people at risk for the development of type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 19;11(11):CD013516. doi: 10.1002/14651858.CD013516.pub2.
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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.
Gerhard Schuler, MD study chair
University of Leipzig
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pioglitazone, simvastatin and pioglitazone + simvastatin in people with Glucose Metabolism Disorders, run by University of Leipzig at 7 sites in Germany.
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 2 inclusion and 8 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: withdrawn, as of the sponsor's last update on 2 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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?
Change in intima media thickness of carotid artery. 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 NCT00306826, 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 2 Feb 2010.