Pioglitazone on Cardiac Function and Large Arteries (PICCOLA Study) (PICCOLA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00485056
Recruitment Status : Completed
First Posted : June 12, 2007
Last Update Posted : August 9, 2016
Information provided by (Responsible Party):
Imperial College London

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Drug: Pioglitazone Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Pioglitazone on Cardiac Function and Large Arteries (PICCOLA)
Study Start Date : April 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo
Crossover arm
Drug: Pioglitazone
45mgs daily
Active Comparator: Pioglitazone
Pioglitazone 45mgs daily
Drug: Pioglitazone
45mgs daily

Primary Outcome Measures :
  1. The primary endpoint will be the TDI E' ratio which is the relatively preload independent measure of ventricular diastolic function. [ Time Frame: 26 weeks ]

Secondary Outcome Measures :
  1. E/E' measured by TDI (a non-invasive measure of preload). [ Time Frame: 26 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00485056

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

Responsible Party: Imperial College London Identifier: NCT00485056     History of Changes
Other Study ID Numbers: EU-IIT-006
First Posted: June 12, 2007    Key Record Dates
Last Update Posted: August 9, 2016
Last Verified: August 2009
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs