Pioglitazone Attenuates Dysmetabolism in Peritoneal Dialysis (PD) Patients

This study has been completed.
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by:
Huashan Hospital
ClinicalTrials.gov Identifier:
NCT01258322
First received: December 9, 2010
Last updated: NA
Last verified: March 2007
History: No changes posted
  Purpose
  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. Study design: Randomized, cross-over trial.
  3. Settings and Participants: Prevalent PD patients (>20 years old, s-triglycerides >1.8 mmol/L) who had never received glitazones were enrolled.
  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. 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.

Condition Intervention
Peritoneal Dialysis
Pioglitazone
Hypertriglyceridemia
Insulin Resistance
Inflammation
Drug: Pioglitazone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Twelve Weeks of Pioglitazone Therapy Significantly Attenuates Dysmetabolism and Reduces Inflammation in Prevalent Peritoneal Dialysis Patients. A Randomized, Cross-over Trial.

Resource links provided by NLM:


Further study details as provided by Huashan Hospital:

Primary Outcome Measures:
  • change of serum TG level [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the change of serum CHO, LDL. HDL level, HOMA-IR, adipocytokines level and CRP [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: January 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pioglitazone Drug: Pioglitazone
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.
Other Name: pioglitazone (Actos®, Takeda®) 15mg

Detailed Description:

Cardiovascular disease (CVD) is the major cause of mortality in chronic kidney disease, including peritoneal dialysis (PD) patients. While survival has not been shown to differ between peritoneal and hemodialysis, because of glucose uptake from the dialysate PD patients are more prone to dyslipidemia, insulin resistance (IR) and obesity. These metabolic disorders are substantially linked to the development of CVD and mortality in this patient population.

Hypertriglyceridemia, reported to be present in 70% of PD patients, is linked to both glucose uptake from the peritoneum and IRand promote vascular damage. Inflammation has been proposed to be a fundamental promoter of atherosclerosis and demonstrated a dose-response relationship between C-reactive protein (CRP) and mortality . Adipocytokines, such as adiponectin,leptin and resistin, also play important roles in the development of dyslipidemia, IR, atherosclerosis, inflammation and CVD in PD patients. Therefore, therapies targeted at metabolic disorder are an important component of treatment for PD patients. Fibrates, peroxisome proliferator-activated receptors (PPAR)-α agonist, can lower serum TG, however, its use in PD patients is limited by its limited efficacy and often-appeared adverse effects such as rhabdomyolysis and hepatic impairment. Nowadays, PPAR-γ agonist, thiazolidinediones (TZDs), represented by pioglitazone and rosiglitazone, exert their hypoglycemic properties through reduction of insulin resistance. For more than ten years, they have been used to control blood glucose in type 2 diabetes mellitus (T2DM). In addition, TZDs have also been noted to have beneficial effects on lipid metabolism and inflammation apart from their effects on glycogenic control. However, the study about TZDs in the treatment of metabolic disorder in PD patients, especially in nondiabetic subjects is very scarce and limited.

We, therefore set out to investigate the effect of TZDs, pioglitazone on hyperlipidemia, insulin resistance, inflammation and adipokine dysmetabolism of PD patients, especially in nondiabetic patients.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.-

Exclusion Criteria:

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).-

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01258322

Sponsors and Collaborators
Huashan Hospital
Baxter Healthcare Corporation
Investigators
Principal Investigator: Tongying Zhu, MD and PhD Huashan Hospital
  More Information

No publications provided

Responsible Party: Dr. Tongying Zhu, Huashan Hospital
ClinicalTrials.gov Identifier: NCT01258322     History of Changes
Other Study ID Numbers: Neph-1000
Study First Received: December 9, 2010
Last Updated: December 9, 2010
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Hypertriglyceridemia
Inflammation
Insulin Resistance
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014