Expired Study
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New York, New York 10016


Purpose:

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.


Study summary:

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.


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.


Study is Available At:


Original ID:

R10-02084


NCT ID:

NCT01393873


Secondary ID:


Study Acronym:


Brief Title:

Progression of Diabetic Retinopathy Post Bariatric Surgery (BS)


Official Title:

The Effect of Bariatric Surgery on the Progression of Diabetic Retinopathy


Overall Status:

Terminated


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

New York University School of Medicine


Oversight Authority:

United States: NYU SOM


Reasons Why Stopped:

Investigator has moved to other state.


Study Type:

Observational


Study Design:

Observational Model: Cohort, Time Perspective: P


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

2


Enrollment Type:

Actual


Overall Contact Information

Official Name:Ann Danoff, M.D.
Principal Investigator
NYU SOM

Study Dates

Start Date:July 2011
Completion Date:July 2012
Completion Type:Actual
Primary Completion Date:July 2012
Primary Completion Type:Actual
Verification Date:September 2012
Last Changed Date:September 26, 2012
First Received Date:July 12, 2011

Study Outcomes

Outcome Type:Primary Outcome
Measure:rapid changes in the level of retinopathy
Time Frame:12 months
Safety Issues:False
Description:whether rapid changes in the level of retinopathy do or do not occur in the transition period following surgery, where weight loss may be rapid causing improvement in insulin resistance and glycemic control.

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:Bariatric surgery pts with Type 2 DM
Description:Primary bariatric surgery pts with Type 2 DM

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:New York University School of Medicine

Samples and Retentions

Study Population: Patients with type 2 diabetes in the bariatric service awaiting metabolic surgery for weight reduction/glucose control therapy.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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