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Effect of Adipokines in Hemodialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01301027
Recruitment Status : Completed
First Posted : February 23, 2011
Results First Posted : October 3, 2016
Last Update Posted : October 3, 2016
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

Tracking Information
First Submitted Date  ICMJE February 18, 2011
First Posted Date  ICMJE February 23, 2011
Results First Submitted Date  ICMJE August 9, 2016
Results First Posted Date  ICMJE October 3, 2016
Last Update Posted Date October 3, 2016
Study Start Date  ICMJE May 2008
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2016)
  • Change in High Molecular Weight Adiponectin (HMW-A) Concentration in Plasma From Baseline to 6 Months [ Time Frame: Baseline and 6 months ]
    The percent difference in HMW-A concentration geometric mean values from baseline to 6 months was calculated for each arm
  • Change in High Sensitivity C-Reactive Protein (hsCRP) Concentration in Plasma From Baseline to 6 Months [ Time Frame: Baseline and 6 months ]
    The percent difference in hsCRP concentration geometric mean values from baseline to 6 months was calculated for each arm
Original Primary Outcome Measures  ICMJE
 (submitted: February 22, 2011)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2016)
  • Change in Tumor Necrosis Factor-α (TNF-α) Concentration in Plasma From Baseline to 6 Months [ Time Frame: Baseline and 6 months ]
    The percent difference in TNF-α concentration geometric mean values from baseline to 6 months was calculated for each arm
  • Change in Interleukin-6 (IL-6) Concentration in Plasma From Baseline to 6 Months [ Time Frame: Baseline and 6 months ]
    The percent difference in IL-6 concentration geometric mean values from baseline to 6 months was calculated for each arm
Original Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2011)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Adipokines in Hemodialysis Patients
Official Title  ICMJE Effects of Pioglitazone on Adiponectin and Inflammatory Markers in Overweight or Obese Hemodialysis Patients: A Double-Blinded Randomized Controlled Trial
Brief 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.

Detailed Description

Randomization:

100 overweight or obese patients will be randomly allocated to oral pioglitazone 15 mg/d or placebo for two weeks by blocks of five using a random number generator and monitored for adverse events including hypoglycemia. If they tolerate the 15 mg pioglitazone or matching placebo for two weeks, participants will be assigned to 30 mg of pioglitazone or matching placebo for 24 more weeks. Those who received 15 mg of pioglitazone will receive 30 mg of pioglitazone for the next 24 weeks. Those who received placebo for initial 2 weeks will receive another placebo that matches the 30 mg pioglitazone pill for 24 weeks.

Baseline:

Participants will have fasting blood drawn for adipokines: Tumor Necrosis Factor-alpha (TNF-alpha), Interleukin-6 (IL-6), high sensitivity C-Reactive Protein (hsCRP), high molecular weight Adiponectin (HMW-A), and leptin. All patients will undergo MRI scans on the mid-week non-dialysis day. Twenty each of overweight/obese patients randomized to pioglitazone or placebo will also undergo subcutaneous fat biopsy on the mid-week non-dialysis day.

Study Period:

Participants will return to the dialysis unit at weeks 2, 4, 6, 10, 14, 18, 22, and 26. During these visits, clinical assessments will be conducted including review of blood sugars, jaundice, weight gain, and visual symptoms. Study treatment compliance will be assessed and details of adverse events experienced, particularly hospitalizations and emergency department visits will be collected. Fasting blood draws for primary and secondary outcomes will be collected on visit weeks 10 and 26.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE End Stage Renal Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Pioglitazone
    15 mg/day pioglitazone for 2 weeks, then 30 mg/day for remaining 24 weeks
    Intervention: Drug: Pioglitazone
  • Placebo Comparator: Placebo
    1 placebo pill a day matching the pioglitazone treatment for 26 weeks
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 30, 2013)
95
Original Estimated Enrollment  ICMJE
 (submitted: February 22, 2011)
100
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01301027
Other Study ID Numbers  ICMJE IRB_00028427
R01DK078112 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Srinvasan Beddhu, University of Utah
Study Sponsor  ICMJE University of Utah
Collaborators  ICMJE
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • University of Colorado, Denver
Investigators  ICMJE
Principal Investigator: Srinivasan Beddhu, M.D. University of Utah
PRS Account University of Utah
Verification Date August 2016

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