Effect of Adipokines in Hemodialysis Patients

NCT ID: NCT01301027

Last Updated: 2016-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2015-12-31

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.

Conditions

End Stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pioglitazone

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

Group Type: ACTIVE_COMPARATOR

Pioglitazone

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

1 pill a day for 26 weeks

Interventions

Pioglitazone

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

Intervention Type: DRUG

Placebo

1 pill a day for 26 weeks

Intervention Type: DRUG

Other Intervention Names

Actos

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Srinvasan Beddhu

MD, Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Srinivasan Beddhu, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

University of Colorado

Denver, Colorado, United States

University of Utah

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

R01DK078112

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB_00028427

Identifier Type: -

Identifier Source: org_study_id