Progression of Diabetic Retinopathy Post Bariatric Surgery (BS)

This study has been terminated.
(Investigator has moved to other state.)
Sponsor:
Information provided by (Responsible Party):
Heekoung A Youn, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01393873
First received: July 12, 2011
Last updated: September 26, 2012
Last verified: September 2012
  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.


Condition
Obesity
Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Bariatric Surgery on the Progression of Diabetic Retinopathy

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • rapid changes in the level of retinopathy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 2
Study Start Date: July 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Bariatric surgery pts with Type 2 DM
Primary bariatric surgery pts with Type 2 DM

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01393873

Locations
United States, New York
NYU SOM
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Ann Danoff, M.D. NYU SOM
  More Information

No publications provided

Responsible Party: Heekoung A Youn, Research coordinator, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01393873     History of Changes
Other Study ID Numbers: R10-02084
Study First Received: July 12, 2011
Last Updated: September 26, 2012
Health Authority: United States: NYU SOM

Keywords provided by New York University School of Medicine:
Obesity
Type 2 DM

Additional relevant MeSH terms:
Diabetes Mellitus
Obesity
Diabetic Retinopathy
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications

ClinicalTrials.gov processed this record on September 18, 2014