Effect of Pioglitazone Therapy for Type 2 Diabetes on Vision

Type 2 Diabetes Clinical Trial

Official title:

Preliminary Safety Study of Pioglitazone Therapy for Diabetes on Macular Thickness and Vision in Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00548158
• Other study ID #: DUB-071127
• Status: Completed
• Phase: N/A
• First received: October 19, 2007
• Last updated: October 19, 2007
• Start date: October 2004
• Est. completion date: April 2006

Study information

• Verified date: October 2007
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ETDRS visual acuity		baseline and at 3 months followup visit
Secondary	retinal thickness measured by OCT		baseline and at 3 months followup visit