End Stage Renal Disease Clinical Trial
Official title:
Adipokines in Hemodialysis Patients
Verified date | April 2013 |
Source | University of Utah |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
This is a double blinded RCT 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.
Status | Enrolling by invitation |
Enrollment | 95 |
Est. completion date | |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Overweight (BMI = 25 kg/m2) - Adult - Chronic hemodialysis - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado | Denver | Colorado |
United States | University of Utah | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Utah | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Colorado, Denver |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To examine if pioglitazone vs. placebo effects plasma concentrations of adiponectin and plasma concentrations of high sensitivity C-reactive protein (hsCRP) as the co-primary endpoints | baseline and 6 months | No | |
Secondary | To compare subcutaneous adipose tissue mRNA expression of adiponectin, TNF-a and IL-6, plasma concentrations of TNF-a and IL-6, insulin resistance, oxidative stress and mid-thigh muscle mass as measured by MRI in pioglitazone vs. placebo | Baseline and 6 months | No |
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