Study In Patients With Type 2 Diabetes Who Are Taking Metformin And Sulfonylurea, Metformin And Insulin, Or Insulin

An Exploratory MRI Study in Type 2 Diabetic Subjects: A Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Measurement of Fluid Volumes by MRI in the Lower Extremities of Subjects Receiving Pioglitazone

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00269061

Enrollment

Registered

2005-12-23

Start date

2006-01-31

Completion date

Unknown

Last updated

2008-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Insulin-Dependent Diabetes Mellitus

Keywords

pioglitazone, diabetes, fluid

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.

Interventions

DRUGpioglitazone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* 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).

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame
Changes in interstitial fluid volume in the lower extremities as measured by MRI.	—

Secondary

Measure	Time frame
Assessments of other indicators of fluid volume changes, including labwork evaluation, fluid compartment volume measurement, direct measurement of the calf.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026