Type 2 Diabetes MellitusPhase 1NCT00232362
Effect of Pioglitazone on Left Ventricular Diastolic Function in Type 2 Diabetes Mellitus
A Phase 1 study testing Pioglitazone (Actos) and Anti-diabetic agent other than pioglitazone or rosiglitazone in people with Type 2 Diabetes Mellitus, run by Texas Tech University Health Sciences Center.
Trial summary
This study is being done to determine if pioglitazone (Actos) is helpful to patients with type 2 diabetes and could possibly prevent harmful consequences of cardiovascular disease in diabetic patients. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Pioglitazone (Actos) and Anti-diabetic agent other than pioglitazone or rosiglitazone
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2007to Jun 2008
- Phase
- Phase 1
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with type 2 diabetes mellitus (DM)
- Ages 18 to 65 years old
- Patients with left ventricular diastolic dysfunction (LVDD) and ejection fraction (EF) > 50%
Who cannot join
- Patients with uncontrolled hypertension
- Patients with active myocardial ischemia with Canadian Cardiovascular Society (CCS) > II or known coronary artery disease (CAD)
- Patients with atrial fibrillation
- Patients with systolic heart failure
- Patients with mitral regurgitation grade 2 or more
- Patients with restrictive cardiomyopathy
Show all 17Show fewer
- Patients with constrictive pericarditis
- Pregnant female patients
- Recent stroke
- Sepsis
- Liver enzymes more than 2.5 times the normal
- Hemoglobin < 11g/dl or hematocrit < 30%
- Terminal cancer
- Patients on fibrates group of lipid lowering agents
- Patients already on pioglitazone or rosiglitazone
- Patients who are placed in the control group may not be currently taking a medication in the glitazones drug class.
- Current or prior use of Pioglitazone or Rosiglitazone within the preceding 6 months.
About this study
This study is being done to determine if pioglitazone (Actos) is helpful to patients with type 2 diabetes and could possibly prevent harmful consequences of cardiovascular disease in diabetic patients.
Read the detailed description
Cross sectional and population-based studies indicate that at least one third of all patients with congestive heart failure (CHF) have a normal or near normal ejection fraction, which is thought to be secondary to diastolic dysfunction or failure. The mortality rates among the patients with diastolic failure ranges from 5-8% annually, as compared with 10-15% among patients with systolic heart failure. The morbidity associated with diastolic heart failure is similar to that of systolic heart failure. Several studies have shown that even simple Doppler evidence of diastolic dysfunction is an independent risk factor for the development of CHF and cardiac death and increased all cause mortality. Several studies indicate that left ventricular diastolic dysfunction (LVDD) represent the earliest preclinical manifestation of diabetic cardiomyopathy that can progress to symptomatic heart failure. Recent studies have demonstrated up to 60% of asymptomatic, normotensive patients with type 2 diabetes have LVDD when assessed by conventional echocardiography including the response to the Valsalva maneuver. A recent study using conventional Doppler, valsalva maneuver, color M-mode echocardiography and tissue doppler imaging assessed the diastolic dysfunction in asymptomatic normotensive patients with diabetes mellitus and found diastolic dysfunction in about 75% of these patients. Cardiovascular disease is the leading cause of death in patients with type 2 diabetes mellitus. Although diabetic patients have a large number of cardiovascular risk factors, like hyperlipidemia and hypertension, the diabetic cardiomyopathy occurs independent of these risk factors. Recently animal models have shown that LVDD may be prevented by chronic treatment with peroxisome-proliferator-activated receptors gamma (PPAR) agonists, like thiazolidinediones, in type 2 diabetic rats. Thiazolidinediones act through PPAR, but the exact mechanism by which they improve LVDD is not known. With this background knowledge, we wanted to study the effect of Pioglitazone, which is PPAR agonist and partial PPAR agonist, on the left ventricular diastolic dysfunction in type 2 diabetic human subjects, which has not been studied so far. If this therapy proves to have beneficial effect on the LVDD it will help in preventing the deleterious consequences of diastolic dysfunction in diabetic patients.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Pioglitazone (Actos), Anti-diabetic agent other than pioglitazone or rosiglitazone
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pioglitazone (Actos)Drug
Anti-diabetic agent other than pioglitazone or rosiglitazoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in diastolic function parameters: early peak to late peak velocity (E/A) ratio
deceleration time (DT)
isovolumic relaxation time (IVRT)
E/A ratio percent change with Valsalva maneuver more than 40%
annular tissue Doppler velocity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2005 (estimated)
- Study startJun 2007
- Study completionJun 2008 (estimated)
Why it stopped: This study was not conducted as the Principal Investigator left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Investigators
- Chanwit Roongsritong, MD, Principal investigator, TTUHSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00232362
- Sponsor's protocol ID
- L05-115
- Status last verified
- Apr 2015
- First submitted
- 30 Sep 2005
- Last updated
- 13 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pioglitazone on Left Ventricular Diastolic Function in Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00232362
- Acronym / sponsor ID
- L05-115
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was not conducted as the Principal Investigator left the institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Study start
- Jun 2007
- Study completion
- Jun 2008 (estimated)
- First posted
- 4 Oct 2005 (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.
This study is being done to determine if pioglitazone (Actos) is helpful to patients with type 2 diabetes and could possibly prevent harmful consequences of cardiovascular disease in diabetic patients.
Detailed description
Cross sectional and population-based studies indicate that at least one third of all patients with congestive heart failure (CHF) have a normal or near normal ejection fraction, which is thought to be secondary to diastolic dysfunction or failure. The mortality rates among the patients with diastolic failure ranges from 5-8% annually, as compared with 10-15% among patients with systolic heart failure. The morbidity associated with diastolic heart failure is similar to that of systolic heart failure. Several studies have shown that even simple Doppler evidence of diastolic dysfunction is an independent risk factor for the development of CHF and cardiac death and increased all cause mortality. Several studies indicate that left ventricular diastolic dysfunction (LVDD) represent the earliest preclinical manifestation of diabetic cardiomyopathy that can progress to symptomatic heart failure. Recent studies have demonstrated up to 60% of asymptomatic, normotensive patients with type 2 diabetes have LVDD when assessed by conventional echocardiography including the response to the Valsalva maneuver. A recent study using conventional Doppler, valsalva maneuver, color M-mode echocardiography and tissue doppler imaging assessed the diastolic dysfunction in asymptomatic normotensive patients with diabetes mellitus and found diastolic dysfunction in about 75% of these patients. Cardiovascular disease is the leading cause of death in patients with type 2 diabetes mellitus. Although diabetic patients have a large number of cardiovascular risk factors, like hyperlipidemia and hypertension, the diabetic cardiomyopathy occurs independent of these risk factors. Recently animal models have shown that LVDD may be prevented by chronic treatment with peroxisome-proliferator-activated receptors gamma (PPAR) agonists, like thiazolidinediones, in type 2 diabetic rats. Thiazolidinediones act through PPAR, but the exact mechanism by which they improve LVDD is not known. With this background knowledge, we wanted to study the effect of Pioglitazone, which is PPAR agonist and partial PPAR agonist, on the left ventricular diastolic dysfunction in type 2 diabetic human subjects, which has not been studied so far. If this therapy proves to have beneficial effect on the LVDD it will help in preventing the deleterious consequences of diastolic dysfunction in diabetic patients.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with type 2 diabetes mellitus (DM)
- Ages 18 to 65 years old
- Patients with left ventricular diastolic dysfunction (LVDD) and ejection fraction (EF) > 50%
Key exclusion criteria (17 listed)
- Patients with uncontrolled hypertension
- Patients with active myocardial ischemia with Canadian Cardiovascular Society (CCS) > II or known coronary artery disease (CAD)
- Patients with atrial fibrillation
- Patients with systolic heart failure
- Patients with mitral regurgitation grade 2 or more
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 (Actos) | Drug | – |
| Anti-diabetic agent other than pioglitazone or rosiglitazone | Drug | – |
Primary outcome
Improvement in diastolic function parameters: early peak to late peak velocity (E/A) ratio
deceleration time (DT)
isovolumic relaxation time (IVRT)
E/A ratio percent change with Valsalva maneuver more than 40%
annular tissue Doppler velocity
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 13 Apr 2015.
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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.
Chanwit Roongsritong, MD principal investigator
TTUHSC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pioglitazone (Actos) and Anti-diabetic agent other than pioglitazone or rosiglitazone in people with Type 2 Diabetes Mellitus, run by Texas Tech University Health Sciences Center.
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 17 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 13 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Improvement in diastolic function parameters: early peak to late peak velocity (E/A) ratio. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2015; AzTrials last refreshed its copy on 3 Nov 2026.