N/A
N=95
Effect of Adipokines in Hemodialysis Patients
End Stage Renal Disease
Bottom Line
View on ClinicalTrials.gov: NCT01301027 ↗Enrolled (actual)
95
Serious AEs
22.1%
Results posted
Oct 2016
Primary outcome: Primary: Change in High Molecular Weight Adiponectin (HMW-A) Concentration in Plasma From Baseline to 6 Months — 38.3; -3.4 percent difference in geometric mean — p=0.047
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pioglitazone (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Utah
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in High Molecular Weight Adiponectin (HMW-A) Concentration in Plasma From Baseline to 6 Months |
38.3; -3.4 | 0.047 sig |
| PRIMARY Change in High Sensitivity C-Reactive Protein (hsCRP) Concentration in Plasma From Baseline to 6 Months |
-29.0; -1.8 | 0.059 |
| SECONDARY Change in Tumor Necrosis Factor-α (TNF-α) Concentration in Plasma From Baseline to 6 Months |
44.9; 39.1 | 0.508 |
| SECONDARY Change in Interleukin-6 (IL-6) Concentration in Plasma From Baseline to 6 Months |
-12.3; -12.5 | 0.984 |
Summary
This is a double blinded randomized clinical trial of pioglitazone vs. placebo in overweight or obese, diabetic and non-diabetic hemodialysis patients. This study will examine whether pioglitazone modulates adipokine production by adipose tissue in hemodialysis patients and whether these changes result in reduction of inflammation, insulin resistance and oxidative stress and increase in muscle mass.
In addition, this study will also examine the associations of adiposity with adipokines and the metabolic milieu in hemodialysis patients to better understand the biology of adipocytes in uremic milieu.
Eligibility Criteria
Inclusion Criteria
- Overweight (Body Mass Index ≥ 25 kilograms per meter squared (kg/m2))
- Adult (18 years or older)
- Chronic hemodialysis patient
- Diabetic (type 2) or insulin resistant
Exclusion Criteria
- <18 years old
- No insulin resistance
- Active liver disease
- Class III or IV New York Heart Association heart failure
- Macular edema or hard exudates near macula on fundoscopy
- Current active malignancy (excluding squamous and basal cell skin cancers)
- Active AIDS
- Chronic lung disease requiring supplemental oxygen therapy
- Enrolled in interventional trials using drugs or devices
- Bone break of long bones, vertebrae, or hips in the past three years
Data sourced from ClinicalTrials.gov (NCT01301027). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.