Pioglitazone on Cardiac Function and Large Arteries (PICCOLA Study)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT00485056
First received: June 11, 2007
Last updated: August 5, 2013
Last verified: August 2009
  Purpose

This study aims to use a novel, sensitive, non-invasive scanning technique to investigate the effects of insulin-sensitizing agent pioglitazone, on heart and artery function.


Condition Intervention Phase
Diabetes
Drug: Pioglitazone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: Pioglitazone on Cardiac Function and Large Arteries (PICCOLA)

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • The primary endpoint will be the TDI E' ratio which is the relatively preload independent measure of ventricular diastolic function. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • E/E' measured by TDI (a non-invasive measure of preload). [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: April 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Crossover arm
Active Comparator: Pioglitazone
Pioglitazone 45mgs daily
Drug: Pioglitazone
45mgs daily
Other Name: Pioglitazone

Detailed Description:

The prevalence of diabetes mellitus and impaired glucose tolerance are nearing epidemic proportions in developed societies. For example in the USA >16 million individuals have diabetes and this number is predicted to double over the next two decades. Diabetes is a major risk factor for death and disability, primarily from cardiovascular disease (CVD).

The mechanisms of how diabetes increases the risk of developing CVD are not fully understood. It is evident from previous studies that diabetes has an adverse effect on both artery and heart function. What is emerging from recent studies is that it is likely that these proven dysfunctions in the arteries and heart interact to increase the risk of CVD.

Insulin-sensitizing agents, such as Pioglitazone, may have a beneficial effect on heart and artery function. This study aims to further our understanding of the effect of these agents on heart and artery using a novel, sensitive, non-invasive scanning technique to investigate the effects of this group of drugs on heart and artery function.

This is a prospective double-blind randomised crossover study comparing the insulin-sensitizing drug, Pioglitazone with a placebo in 24 volunteers. Following a >1 week run-in period subjects will be randomised double-blind to 1 of 2 treatment sequences. Subjects will either receive the active drug (Pioglitazone 45mg/day) for a 12 week period, followed by a 2 week washout and then the placebo drug for 12 weeks OR they will receive the placebo drug for 12 weeks, followed by the 2 week washout and 12 weeks of the active drug (Pioglitazone 45mg/day).

This design was chosen to test the null hypothesis that the active drug will have no effect on diastolic heart function. The use of a placebo is essential to ensure that any benefits found can be attributed to the active drug. The design also allows us to minimise the number of subjects needed and is the gold standard approach to avoid observer bias.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female of any age with Type 2 Diabetes

Exclusion Criteria:

  • Subjects will be excluded if they have any of the following:

    • Known coronary heart disease,
    • Patients receiving Insulin,
    • Uncontrolled hypertension (i.e. >160mmHg systolic or >95mmHg diastolic),
    • Systolic dysfunction (ejection fraction <50%),
    • Heart Valve Disease,
    • Proliferative or pre-proliferative retinopathy,
    • Severe hepatic or renal impairment.
    • Possible pregnancy
    • Malignancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00485056

Locations
United Kingdom
International Centre for Circulatory Health
London, United Kingdom, W2 1PG
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Alun D Hughes, phd Imperial College London
  More Information

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT00485056     History of Changes
Other Study ID Numbers: EU-IIT-006
Study First Received: June 11, 2007
Last Updated: August 5, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
Diabetes
Tissue doppler imaging
Wave intensity analysis.

Additional relevant MeSH terms:
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014