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Adipokines in Hemodialysis Patients

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Colorado, Denver
Information provided by (Responsible Party):
Srinvasan Beddhu, University of Utah
ClinicalTrials.gov Identifier:
NCT01301027
First received: February 18, 2011
Last updated: April 18, 2013
Last verified: April 2013
History of Changes

February 18, 2011
April 18, 2013
May 2008
December 2015   (final data collection date for primary outcome measure)
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 [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01301027 on ClinicalTrials.gov Archive Site
To compare subcutaneous adipose tissue mRNA expression of adiponectin, TNF-α and IL-6, plasma concentrations of TNF-α and IL-6, insulin resistance, oxidative stress and mid-thigh muscle mass as measured by MRI in pioglitazone vs. placebo [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
Same as current
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Not Provided
 
Adipokines in Hemodialysis Patients
Adipokines in Hemodialysis Patients

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.
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Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • End Stage Renal Disease
  • Hemodialysis
  • Drug: Pioglitazone
    15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
    Other Name: Actos
  • Drug: Placebo
    1 pill a day for 26 weeks
  • Active Comparator: Pioglitazone
    Intervention: Drug: Pioglitazone
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
95
Not Provided
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01301027
IRB_00028427, R01DK078112
Yes
Srinvasan Beddhu, University of Utah
University of Utah
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • University of Colorado, Denver
Principal Investigator: Srinivasan Beddhu, M.D. University of Utah
University of Utah
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP