Pioglitazone Attenuates Dysmetabolism in Peritoneal Dialysis (PD) Patients

NCT01258322 | Completed DMC

• 1 other identifier: Neph-1000
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.Background:Cardiovascular disease (CVD) is the major cause of mortality in peritoneal dialysis (PD) patients, in whom it is partly attributable to a higher prevalence of dysmetabolism. Currently, few treatments are available with a proven effect on dyslipidemia, insulin resistance and inflammation in this patient group.
2. 2.Study design: Randomized, cross-over trial.
3. 3.Settings and Participants: Prevalent PD patients (\>20 years old, s-triglycerides \>1.8 mmol/L) who had never received glitazones were enrolled.
4. 4.Interventions: Participants were randomized to receive either oral pioglitazone (PIO; 15 mg once daily) and no pioglitazone, both for 12 weeks and in random order, with a four-week wash out in between.
5. 5.Outcomes and measurements: The primary endpoint was change of serum triglyceride (TG) level during the PIO as compared to no PIO. Secondary endpoints included changes in other lipid levels, HOMA-IR, adipocytokines and CRP. Outcome effects were assessed using a GLM.

Conditions

Peritoneal Dialysis; Pioglitazone; Hypertriglyceridemia; Insulin Resistance; Inflammation

Outcome Measures

Primary Outcomes (1)

• change of serum TG level

  12 weeks

Secondary Outcomes (1)

• the change of serum CHO, LDL. HDL level, HOMA-IR, adipocytokines level and CRP

  12 weeks

Study Arms (1)

pioglitazone

EXPERIMENTAL

Drug: Pioglitazone

Interventions

Pioglitazone DRUG

The patients were randomized divided into 2 groups; one received no pioglitazone for lowing triglyceride, one with oral pioglitazone (Actos®, Takeda®) 15mg once daily for 12 weeks. After a four-week wash out, patients then continued with the alternate therapy.

Also known as: pioglitazone (Actos®, Takeda®) 15mg

pioglitazone

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients received more than one month regular continuous ambulatory peritoneal dialysis(CAPD) or intermittent peritoneal dialysis(IPD). The causes of chronic renal failure were diabetes and non-diabetes.-

You may not qualify if:

• history of allergy to thiazolidinediones and fenofibrate; history of any sever adverse event for fibrate that can't be tolerated by the patients; patient can not be follow-up regularly; history of myocardial infarction(MI) or coronary artery bypass graft (CABG) surgery within the past 1 month, history of cerebral vascular accident (CVA) or percutaneous transluminal coronary angioplasty(PTCA) within the past 6 months; chronic use of non-steroidal anti-inflammatory drugs(NSAIDs), steroids or immunosuppressives; patient with the acute infection; patient with malignant tumor; have the evidence of severe hepatic injury (ALT/AST\>100u/L).-

Sponsors & Collaborators

• Huashan Hospital: lead
• Baxter Healthcare Corporation: collaborator

MeSH Terms

Conditions

Hypertriglyceridemia; Insulin Resistance; Inflammation

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Tongying Zhu, MD and PhD

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 9, 2010
• First Posted: December 10, 2010
• Study Start: January 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: December 10, 2010

Record last verified: 2007-03