Obesity Clinical Trial
Official title:
The Effect of Bariatric Surgery on the Progression of Diabetic Retinopathy
Studies conducted assessing diabetic eye disease have shown a progression of diabetic retinopathy with rapid improvement of glycemic control during pregnancy and in patients with type 1 diabetes. It is also well documented that bariatric surgery may result in rapid improvement of glycemic control in obese patients with type 2 diabetes. To our knowledge the progression of diabetic eye disease seen in pregnancy and type 1 diabetes has not been studied in obese type 2 diabetics undergoing bariatric surgery. To this end, this study will examine the effects of rapid glycemic control which is seen in type 2 diabetics following bariatric surgery on the progression of diabetic retinopathy.
Participants will be referred from the Department of Bariatric Surgery at NYU. The
investigators plan to enroll 50 patients in this pilot study.
A baseline eye exam will be conducted prior to surgery. Data, such as preoperative HbA1c
level, weight, BMI, duration and control of diabetes, current medication regimen, and the
grade of retinopathy will be noted. Study participants will have a baseline eye exam within
three months of the scheduled surgery, followed by regular follow-up visits at 3 months, 6
months, 9 months, and 1 year. At each visit the following measures will be assessed: (1)
weight, (2) blood pressure, (3) glycemic control as assessed by HbA1C, (4)level of
retinopathy, and (5) visual acuity using the EDTRS acuity chart.
The eye examinations will consist of a measure of best-corrected visual acuity, slit lamp
examination to assess pressure, and a dilated funduscopic examination to determine the
presence and/or level of retinopathy. The level of retinopathy will be characterized as:
(0)None, (1) Mild, (2) Moderate, (3) Severe, and (4) Proliferative. In addition, the
presence or absence of cystoid macular edema (CME) will be noted as (a) no CME or (b) CME
present.
At the initial visit, a baseline questionnaire will be given to participants to gather
background information on demographics and pertinent medical history. During each follow up
visit, an additional questionnaire will be given to monitor changes in factors such as
medications, blood pressure, and weight that may occur after bariatric surgery.
HbA1c measurements will be checked every 3 months in accordance with current standard of
care recommendations. Due to established evidence of rapid improvement in glycemic control
shortly after bariatric surgery, it is essential that the investigators have this lab data
and perform funduscopic examinations at these intervals, to monitor improvement in glycemic
control ascertain associations between changes in HbA1c levels and progression of
retinopathy.
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