Clinical trial NCT01393873: Progression of Diabetic Retinopathy Post Bariatric Surgery (BS)
Official title: The Effect of Bariatric Surgery on the Progression of Diabetic Retinopathy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Obesity
Diabetes Mellitus
Keywords: Obesity
Type 2 DM
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2011-07-13
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with type 2 diabetes in the bariatric service awaiting metabolic surgery for weight reduction/glucose control therapy.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* All patients, both male and female greater than 18 years old, with type 2 diabetes referred for bariatric surgery.

Exclusion Criteria:

* Patients will not be included in the study if they are pregnant, have HIV or any retinal vascular diseases (e.g. BRVO, CRVO) besides retinopathy.

Primary outcomes:
measure: rapid changes in the level of retinopathy
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU SOM
state: New York
Study officials:
affiliation: NYU SOM
name: Ann Danoff, M.D.
role: PRINCIPAL_INVESTIGATOR
References: