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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
  Purpose

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.


Condition Intervention
End Stage Renal Disease
Hemodialysis
 Drug: Pioglitazone
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Adipokines in Hemodialysis Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 95
Study Start Date: May 2008
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pioglitazone Drug: Pioglitazone
15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
Other Name: Actos
Placebo Comparator: Placebo Drug: Placebo
1 pill a day for 26 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01301027

Locations
United States, Colorado
University of Colorado
Denver, Colorado, United States, 80262
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Colorado, Denver
Investigators
Principal Investigator: Srinivasan Beddhu, M.D. University of Utah
  More Information

No publications provided

Responsible Party: Srinvasan Beddhu, MD, Associate Professor of Medicine, University of Utah
ClinicalTrials.gov Identifier: NCT01301027     History of Changes
Other Study ID Numbers: IRB_00028427, R01DK078112
Study First Received: February 18, 2011
Last Updated: April 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
End stage renal disease
Hemodialysis
Pioglitazone
Adipokines

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
 Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013