Peroxisome Proliferator-Activated Receptor-Gamma (PPAR-Gamma) Agonist in Diabetic End-Stage Renal Disease Patients - Full Text View

Sponsored by:	The University of Hong Kong
Information provided by:	The University of Hong Kong
ClinicalTrials.gov Identifier:	NCT00745914

Purpose

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.

Condition	Intervention
Endstage Renal Disease Diabetes	Drug: rosiglitazone Drug: Placebo

Drug Information available for: Rosiglitazone Rosiglitazone Maleate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized Placebo-Controlled Study to Evaluate the Efficacy of Peroxisome Proliferator-Activated Receptor-Gamma (PPAR-Gamma) Agonist in Inducing Carotid Atherosclerotic Plaque Regression in Diabetic End-Stage Renal Disease Patients

Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:

Change in carotid plaque volume [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in inflammatory markers include C-reactive protein, interleukin-6, adiponectin, metalloproteinases [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	September 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental rosiglitazone	Drug: rosiglitazone oral rosiglitazone 4mg daily for 12 weeks, then 4mg BD for 36 weeks
2: Placebo Comparator placebo	Drug: Placebo

Detailed Description:

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).

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00745914

Contacts

Contact: Angela YM Wang, MD, FRCP

852-28554111 ext 4949

aymwang@hku.hk

Locations

Hong Kong
Queen Mary Hospital, Tung Wah Hospital
Hong Kong, Hong Kong, 0000

Sponsors and Collaborators

The University of Hong Kong

Investigators

Principal Investigator:

Angela YM Wang, MD, FRCP

Queen Mary Hospital, University of Hong Kong

More Information

Responsible Party:	Queen Mary Hospital, University of Hong Kong ( Dr Wang Angela Yee-Moon )
Study ID Numbers:	A111-103
Study First Received:	September 1, 2008
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00745914
Health Authority:	Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:

PPAR-gamma, diabetic, kidney disease, atherosclerosis

Study placed in the following topic categories:

Atherosclerosis
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Diabetes Mellitus

Kidney Failure, Chronic
Kidney Diseases
Rosiglitazone
Kidney Failure

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009