NCT00269061

Brief Summary

This study will use Magnetic Resonance Imaging (MRI) techniques to evaluate changes in fluid volume in the lower legs of diabetic patients who add either pioglitazone or placebo to their current diabetic regimen.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2005

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
Last Updated

October 16, 2008

Status Verified

October 1, 2008

First QC Date

December 22, 2005

Last Update Submit

October 15, 2008

Conditions

Non-Insulin-Dependent Diabetes Mellitus

Keywords

pioglitazonediabetesfluid

Outcome Measures

Primary Outcomes (1)

  • Changes in interstitial fluid volume in the lower extremities as measured by MRI.

Secondary Outcomes (1)

  • Assessments of other indicators of fluid volume changes, including labwork evaluation, fluid compartment volume measurement, direct measurement of the calf.

Interventions

pioglitazoneDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must have been diagnosed with Type 2 diabetes at least three months prior to screening.
  • Must be taking either metformin and a sulfonylurea, metformin and insulin, or insulin only, and doses of these medications must have been stable for at least three months.
  • Must have a Body Mass Index (BMI) of between 24 and 35.
  • If female, the subject must be post-menopausal.
  • HbA1c levels must be between 7% and 10%.
  • Subjects must be eligible for MRI scanning (ie, no metal implants, pacemaker, etc).

You may not qualify if:

  • Suffer from claustrophobia.
  • Use of tobacco, nicotine, or illegal drugs of abuse.
  • Use of caffeine within two days prior to each study visit.
  • HIV, hepatitis, edema, untreated blood pressure problems, heart, lung, nervous system or kidney disease, history of blood clots in the legs, diabetic neuropathy, or untreated thyroid disease.
  • Use of drugs or medications that affect the levels of fluid in the body, such as diuretics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • GSK Clinical Trials, MD

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 22, 2005

First Posted

December 23, 2005

Study Start

January 1, 2006

Last Updated

October 16, 2008

Record last verified: 2008-10

Locations

US(1)