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

NCT00745914 | Completed DMC

• 1 other identifier: A111-103
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Endstage Renal Disease; Diabetes

Keywords

PPAR-gamma, diabetic, kidney disease, atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Change in carotid plaque volume

  12 months

Secondary Outcomes (1)

• Change in inflammatory markers include C-reactive protein, interleukin-6, adiponectin, metalloproteinases

  12 months

Study Arms (2)

1

EXPERIMENTAL

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

Drug: Pioglitazone

2

PLACEBO COMPARATOR

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

Drug: Placebo comparator

Interventions

Pioglitazone DRUG

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

Also known as: Actos

1

Placebo comparator DRUG

Placebo comparator

Also known as: Placebo

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (2)

Queen Mary Hospital and Tung Wah Hospital

Hong Kong, Hong Kong, 0000, Hong Kong

Location

Queen Mary Hospital, Tung Wah Hospital

Hong Kong, 0000, Hong Kong

Location

MeSH Terms

Conditions

Diabetes Mellitus; Kidney Diseases; Atherosclerosis

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Angela YM Wang, MD, FRCP

  Queen Mary Hospital, University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 1, 2008
• First Posted: September 3, 2008
• Study Start: September 1, 2008
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 10, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (2)