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

Pioglitazone on Cardiac Function and Large Arteries (PICCOLA)

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.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, W2 1PG
    • International Centre for Circulatory Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Crossover arm	Drug: Pioglitazone; 45mgs daily
Active Comparator: Pioglitazone; Pioglitazone 45mgs daily	Drug: Pioglitazone; 45mgs daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary endpoint will be the TDI E' ratio which is the relatively preload independent measure of ventricular diastolic function.	26 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
E/E' measured by TDI (a non-invasive measure of preload).	26 weeks

Collaborators and Investigators

• Sponsor: Imperial College London
• Investigators: Principal Investigator: Alun D Hughes, phd, Imperial College London

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: June 11, 2007
• First Submitted That Met QC Criteria: June 11, 2007
• First Posted (Estimate): June 12, 2007

Study Record Updates

• Last Update Posted (Estimate): August 9, 2016
• Last Update Submitted That Met QC Criteria: August 8, 2016
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Keywords: Diabetes; Tissue doppler imaging; Wave intensity analysis.
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Pioglitazone
• Other Study ID Numbers: EU-IIT-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO