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Effect of Pioglitazone Therapy for Type 2 Diabetes on Vision

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ClinicalTrials.gov Identifier: NCT00548158
Recruitment Status : Completed
First Posted : October 23, 2007
Last Update Posted : October 23, 2007
Sponsor:
Information provided by:
University of California, San Diego

Brief Summary:
We are studying patients with diabetes who under proper medical care and administer an approved drug. Our interest is if this drug has any sideeffect on vision and if this drug may cause swelling of the retina.

Condition or disease
Type 2 Diabetes

Detailed Description:
To evaluate the safety of pioglitazone treatment for diabetes. Recent reports suggest that oral glitazone treatment may cause or exacerbate retinal edema. We hypothesized that glitazone treatment may cause subclinical edema evidenced by increased retinal thickness. We will conduct a double-masked, prospective safety study of 19 subjects undergoing placebo-controlled treatment with pioglitazone. Patient treatment consisted of either insulin with placebo or insulin with pioglitazone. The main outcome measures are ETDRS visual acuity and retinal thickness measured with optical coherence tomography.

Study Type : Observational
Actual Enrollment : 19 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Preliminary Safety Study of Pioglitazone Therapy for Diabetes on Macular Thickness and Vision in Type 2 Diabetes
Study Start Date : October 2004
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. ETDRS visual acuity [ Time Frame: baseline and at 3 months followup visit ]

Secondary Outcome Measures :
  1. retinal thickness measured by OCT [ Time Frame: baseline and at 3 months followup visit ]


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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Male or female patients with type 2 diabetes mellitus on insulin therapy, 30-75 years of age with Hgb 1c values between 7.5 - 10% and a BMI of < 40kg/m2. Patients were enrolled if they have been on a stable anti-hypertensive and lipid regimen for 90 days prior to study randomization.
Criteria

Inclusion Criteria:

  • Male or female patients with type 2 diabetes mellitus on insulin therapy, 30-75 years of age with Hgb 1c values between 7.5 - 10% and a BMI of < 40kg/m2.
  • Patients were enrolled if they have been on a stable anti-hypertensive and lipid regimen for 90 days prior to study randomization.
  • Patients must have had the ability to understand the requirements of the study, provide written consent and agree to abide by study requirements.

Exclusion Criteria:

  • Prior treatment with sulfonylurea, or metformin within 21 days before study entry, prior treatment with NSAIDs, or diuretics within 21 days of screening, serum creatinine levels above 1.5 mg/dl for males or above 1.4 for females or creatinine clearance less than 70 ml/min by Cockcroft and Gault, or serum albumin levels of less than 2.5 gm/dl.
  • Other exclusion criteria were elevated hepatic enzymes (aspartate aminotransferase or alanine aminotransferase more than 2.5 times upper limit of normal) or uncontrolled or untreated significant pulmonary, neurological condition, or cardiovascular disease, including hypertension, congestive heart failure (specifically New York Heart Association Type III or IV patients), angina, peripheral vascular disease, or greater than +1 peripheral edema.
  • Furthermore, any patients with any condition that would jeopardize their safety or affect the validity of the trial results were excluded from this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00548158


Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: William R Freeman, MD University of California, San Diego

ClinicalTrials.gov Identifier: NCT00548158     History of Changes
Other Study ID Numbers: DUB-071127
First Posted: October 23, 2007    Key Record Dates
Last Update Posted: October 23, 2007
Last Verified: October 2007

Keywords provided by University of California, San Diego:
diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs