NCT01301027

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 23, 2011

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
10 months until next milestone

Results Posted

Study results publicly available

October 3, 2016

Completed
Last Updated

October 3, 2016

Status Verified

August 1, 2016

Enrollment Period

7.6 years

First QC Date

February 18, 2011

Results QC Date

August 9, 2016

Last Update Submit

August 9, 2016

Conditions

End Stage Renal Disease

Keywords

End stage renal diseaseHemodialysisPioglitazoneAdipokines

Outcome Measures

Primary Outcomes (2)

  • Change in High Molecular Weight Adiponectin (HMW-A) Concentration in Plasma From Baseline to 6 Months

    The percent difference in HMW-A concentration geometric mean values from baseline to 6 months was calculated for each arm

    Baseline and 6 months

  • Change in High Sensitivity C-Reactive Protein (hsCRP) Concentration in Plasma From Baseline to 6 Months

    The percent difference in hsCRP concentration geometric mean values from baseline to 6 months was calculated for each arm

    Baseline and 6 months

Secondary Outcomes (2)

  • Change in Tumor Necrosis Factor-α (TNF-α) Concentration in Plasma From Baseline to 6 Months

    Baseline and 6 months

  • Change in Interleukin-6 (IL-6) Concentration in Plasma From Baseline to 6 Months

    Baseline and 6 months

Study Arms (2)

Pioglitazone

ACTIVE COMPARATOR

15 mg/day pioglitazone for 2 weeks, then 30 mg/day for remaining 24 weeks

Drug: Pioglitazone

Placebo

PLACEBO COMPARATOR

1 placebo pill a day matching the pioglitazone treatment for 26 weeks

Drug: Placebo

Interventions

PioglitazoneDRUG

15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks

Also known as: Actos
Pioglitazone
PlaceboDRUG

1 pill a day for 26 weeks

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \<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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Colorado

Denver, Colorado, 80262, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Srinivansan Beddhu, M.D.
Organization
University of Utah
srinivansan.beddhu@hsc.utah.edu
801-585-3810

Study Officials

  • Srinivasan Beddhu, M.D.

    University of Utah

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Associate Professor of Medicine

Study Record Dates

First Submitted

February 18, 2011

First Posted

February 23, 2011

Study Start

May 1, 2008

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

October 3, 2016

Results First Posted

October 3, 2016

Record last verified: 2016-08

Locations

US(2)