Inflammation Clinical Trial
Official title:
Twelve Weeks of Pioglitazone Therapy Significantly Attenuates Dysmetabolism and Reduces Inflammation in Prevalent Peritoneal Dialysis Patients. A Randomized, Cross-over Trial.
Verified date | March 2007 |
Source | Huashan Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | September 2008 |
Est. primary completion date | September 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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).- |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Huashan Hospital | Baxter Healthcare Corporation |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change of serum TG level | 12 weeks | ||
Secondary | the change of serum CHO, LDL. HDL level, HOMA-IR, adipocytokines level and CRP | 12 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03995979 -
Inflammation and Protein Restriction
|
N/A | |
Completed |
NCT03255187 -
Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Completed |
NCT03577223 -
Egg Effects on the Immunomodulatory Properties of HDL
|
N/A | |
Completed |
NCT04383561 -
Relationship Between LRG and Periodontal Disease
|
N/A | |
Active, not recruiting |
NCT03622632 -
Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
|
||
Completed |
NCT06216015 -
Exercise Training and Kidney Transplantation
|
N/A | |
Completed |
NCT04856748 -
Nomogram to Diagnose Prostatic Inflammation (PIN) in Men With Lower Urinary Tract Symptoms
|
||
Completed |
NCT05529693 -
Efficacy of a Probiotic Strain on Level of Markers of Inflammation in an Elderly Population
|
N/A | |
Recruiting |
NCT05415397 -
Treating Immuno-metabolic Depression With Anti-inflammatory Drugs
|
Phase 3 | |
Recruiting |
NCT05670301 -
Flemish Joint Effort for Biomarker pRofiling in Inflammatory Systemic Diseases
|
N/A | |
Recruiting |
NCT04543877 -
WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study
|
Early Phase 1 | |
Recruiting |
NCT05775731 -
Markers of Inflammation and of the Pro-thrombotic State in Hospital Shift and Day Workers
|
||
Completed |
NCT03859934 -
Metabolic Effects of Melatonin Treatment
|
Phase 1 | |
Completed |
NCT03429920 -
Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors
|
N/A | |
Completed |
NCT06065241 -
Quantifiably Determine if the Botanical Formulation, LLP-01, Has a Significant Clinical Effect on Proteomic Inflammatory Biomarkers and Epigenetic Changes in Healthy, Older Individuals.
|
N/A | |
Completed |
NCT05864352 -
The Role of Dietary Titanium Dioxide on the Human Gut Microbiome and Health
|
||
Completed |
NCT03318731 -
Efficacy and Safety of Fenugreek Extract on Markers of Muscle Damage and Inflammation in Untrained Males
|
N/A | |
Not yet recruiting |
NCT06134076 -
Comparing Effects of Fermented and Unfermented Pulses and Gut Microbiota
|
N/A | |
Not yet recruiting |
NCT06422494 -
The Role of the Adrenergic System in Hypoglycaemia Induced Inflammatory Response in People With Type 1 Diabetes and People Without Type 1 Diabetes-RAID-II
|
N/A |