Progression of Diabetic Retinopathy Post Bariatric Surgery (BS)

NCT01393873 | Terminated

• 1 other identifier: R10-02084
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Diabetes Mellitus

Keywords

Obesity; Type 2 DM

Outcome Measures

Primary Outcomes (1)

• rapid changes in the level of retinopathy

  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.

  12 months

Study Arms (1)

Bariatric surgery pts with Type 2 DM

Primary bariatric surgery pts with Type 2 DM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU SOM

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ann Danoff, M.D.

  NYU SOM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research coordinator

Study Record Dates

• First Submitted: July 12, 2011
• First Posted: July 13, 2011
• Study Start: July 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: September 27, 2012

Record last verified: 2012-09

Locations

US (1)