Peroxisome Proliferator-Activated Receptor-gamma (PPAR-gamma) Agonist in Diabetic End-Stage Renal Disease Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2013-12-31

Brief Summary

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To test the hypothesis that PPAR-gamma agonist, rosiglitazone, induces carotid plaque regression in diabetic ESRD patients on maintenance PD via its anti-inflammatory property.

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Detailed Description

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End-stage renal disease (ESRD) patients are at an increased risk of accelerated atherosclerosis and cardiovascular morbidity and mortality. Non-traditional risk factors such as inflammation and insulin resistance have important contributions to accelerated atherosclerosis in ESRD patients receiving long-term peritoneal dialysis (PD). The peroxisome proliferator-activated receptor-g (PPAR-g) is a member of the nuclear receptor family of ligand-dependent transcription factors. Activation of the PPAR-g has been shown in both clinical and experimental studies to have anti-inflammatory and anti-atherosclerotic properties other than insulin-sensitizing effects. Recent study also showed that PPAR-g agonists reduce plaque inflammation by inhibiting the activation of proinflammatory genes responsible for plaque development and growth. Hence, this study aims to examine the effects of PPAR-g activation on the progression of carotid plaque in diabetic ESRD patients receiving long-term PD using high-resolution magnetic resonance imaging (MRI).

Conditions

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Endstage Renal Disease Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Pioglitazone drug 15mg daily for 3 months then 30mg for 9 months (Peroxisome Proliferator-Activated Receptor-gamma agonist)

Group Type EXPERIMENTAL

Pioglitazone

Intervention Type DRUG

oral Pioglitazone 15mg daily for 12 weeks, then 30mg daily for 36 weeks

2

placebo comparator drug 15mg daily for 3months, then 30mg for 9 months

Group Type PLACEBO_COMPARATOR

Placebo comparator

Intervention Type DRUG

Placebo comparator

Interventions

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Pioglitazone

oral Pioglitazone 15mg daily for 12 weeks, then 30mg daily for 36 weeks

Intervention Type DRUG

Placebo comparator

Intervention Type DRUG

Other Intervention Names

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Actos Placebo

Eligibility Criteria

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Inclusion Criteria

* Diabetic ESRD patients receiving long-term PD treatment, with carotid plaque (defined as focal intima-media thickening \>1mm) present on screening ultrasonography
* Patients who provide informed consent for the study

Exclusion Criteria

* Patients with systemic inflammatory disease such as systemic lupus erythematosus
* Patients with chronic liver disease or cirrhosis
* Patients with current active malignancy
* Patients with chronic rheumatic heart disease or congenital heart disease
* Patients with poor general condition
* Patients with plan for living related kidney transplant within coming 1 year
* Patients with pre-existing class III/IV heart failure,
* Patients with recurrent hypoglycemia
* Patients already on glitazone treatment
* Female patients with pregnancy
* Patients with contraindications for MRI examination including those with pacemaker or metallic implant.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No