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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Wang Angela Yee-Moon, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00745914
First received: September 1, 2008
Last updated: June 11, 2013
Last verified: June 2013
  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: Pioglitazone
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Pioglitazone drug (Peroxisome Proliferator-Activated Receptor-gamma agonist)
Drug: Pioglitazone
oral Pioglitazone 15mg daily for 12 weeks, then 30mg daily for 36 weeks
Other Name: Actos
Placebo Comparator: 2
placebo comparator drug
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
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: NCT00745914

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

No publications provided

Responsible Party: Wang Angela Yee-Moon, Dr, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT00745914     History of Changes
Other Study ID Numbers: A111-103
Study First Received: September 1, 2008
Last Updated: June 11, 2013
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:
PPAR-gamma, diabetic, kidney disease, atherosclerosis

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014