Effect of Pioglitazone on Oxidative Load, Inflammatory End-Points and Vascular Reactivity in Obese Non-Diabetic Patients: A Dose Ranging Study

NCT01161394 | Completed Phase 4 DMC

• 1 other identifier: 1851
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Pioglitazone decreases oxidative load, inflammatory end points and improves vascular reactivity in obese patients in a dose dependent manner and that this effect is independent of its glucose lowering effects.

Conditions

Inflammation

Outcome Measures

Primary Outcomes (1)

• Inflammation

  Percent change in NFkb at baseline and after 1, 2, 4, 6, and 12 weeks of pioglitazone therapy.

  12 weeks

Secondary Outcomes (1)

• inflammation

  12 weeks

Study Arms (3)

Pioglitazone 15mg

EXPERIMENTAL

8 patient will receive this drug

Drug: Pioglitazone 15mg

pioglitazone 30mg

EXPERIMENTAL

8 patients will get this drug

Drug: pioglitazone 30mg

Placebo

PLACEBO COMPARATOR

8 patient will get this drug

Drug: placebo

Interventions

Pioglitazone 15mg DRUG

Pioglitazone 15mg

pioglitazone 30mg DRUG

pioglitazone 30mg

placebo DRUG

Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Obese (BMI\>=30)
• Age: 20 to 65 years of age inclusive
• Without established clinical coronary artery disease (documented history or myocardial infarction, typical angina and an exercise ECG positive for ischemia or angiographic evidence of CAD)
• Good health as evidence by History and Physical exam
• Female subjects must be:
• Postmenopausal for at least one year or Surgically incapable of childbearing (i.e. have had a hysterectomy or tubal ligation) or, if capable of childbearing a subject, must be practicing an acceptable method of contraception.
• Subject will be available for duration of the study and willing to comply with all study requirements.

You may not qualify if:

• Diabetes Mellitus
• Allergy or sensitivity to Pioglitazone
• Current use of Insulin therapy.
• Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks
• Hepatic disease (transaminase \> 3 times normal)
• Renal impairment (Creatinine clearance \< 50 mL/min)
• History of drug or alcohol abuse
• COPD
• Participation in any other concurrent clinical trial
• Any other life-threatening, non-cardiac disease
• Use of an investigational agent or therapeutic regimen within 30 days of study
• Pregnancy or nursing

Sponsors & Collaborators

• University at Buffalo: lead
• Takeda Pharmaceuticals North America, Inc.: collaborator

Study Sites (1)

Millard Fillmore gates Hospital

Buffalo, New York, 14226, United States

Location

MeSH Terms

Conditions

Inflammation

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Paresh Dandona, MD

  Kaleida Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 12, 2010
• First Posted: July 13, 2010
• Study Completion: October 1, 2003
• Last Updated: January 27, 2022

Record last verified: 2022-01

Locations

US (1)