Results from the STAMPEDE trial indicate that two years after bariatric surgery for patients with type 2 diabetes, there has been no change in diabetic retinopathy. Therefore, regular eye exams are still important. So say investigators presenting at last month’s American Diabetes Association Scientific Sessions.

“I wasn’t sure what gastric bypass would do to diabetic retinopathy,” lead author Rishi P. Singh, MD, staff physician at the Cole Eye Institute, in Cleveland Clinic, Ohio, told Medscape Medical News. “I was pleasantly reassured by the fact that they didn’t have a higher incidence of retinopathy or significant progression of the disease.”

Dr. Singh reported 2-year ophthalmology findings from STAMPEDE at the American Diabetes Association (ADA) Scientific Sessions. “This is the first time that a prospective, randomized clinical trial has shown that intensive medical management vs gastric bypass doesn’t appear to increase the retinopathy incidence or progression, nor does it increase the rate of vision loss or changes in intraocular blood pressure (a sign of glaucoma),” he commented.

“The take-away point is that… ophthalmic management of our [diabetic] patients through yearly evaluations — which is what the ADA and [American Academy of Ophthalmology] AAO recommend — should still continue,” he cautioned.

“Despite the fact that these patients had essentially normal HbA1c values [at] year 2 in the gastric-bypass group, that doesn’t mean that they were free of retinopathy, so it’s important to follow those patients long term and monitor them for eye complications.”

Asked to comment, bariatric surgeon Bruce M. Wolfe, MD, at Oregon Health and Science University, Portland, said it will take many more years to begin to see any impact upon retinopathy.

“The induction of remission or improvement in diabetes control is positive for the patient, but drawing conclusions about the many-year process of diabetic complications of diabetic neuropathy or diabetic retinopathy is premature.”

Patients Should Know the Truth

Patients who are informed that their diabetes has gone into remission after they have had bariatric surgery may think, “I don’t need to go to these eye assessments anymore,” he added, but that would be too hasty, he stressed.

Diabetes is likely to recur in some patients — possibly in 5, 10, or 20 years — and those patients are at increased risk for microvascular complications. “I agree with the authors that it is important for diabetic patients to continue to have regular eye examinations,” which can spot any changes and lead to earlier treatment to delay disease progression, he told Medscape Medical News.

After patients with type 2 diabetes have bariatric surgery, their glycemic control improves. However, it is not yet known how these rapid changes in HbA1c affect the progression of microvascular complications such as retinopathy.

There have been some reports of improvements, but other studies have reported worsening of these outcomes, as was seen in the DCCT trial or in a small series of patients presented at last year’s ADA meeting, Dr. Singh explained.

STAMPEDE randomized 150 obese patients with uncontrolled type 2 diabetes to intensive medical therapy alone (50 patients), Roux-en-Y gastric-bypass surgery (50) or sleeve gastrectomy (50). To be eligible, patients had to be 20 to 60 years old and have an HbA1c greater than 7% and a body mass index (BMI) of 27 to 43 kg/m2.

Intensive medical therapy consisted of antidiabetic therapeutic agents plus diet and lifestyle counseling and regular follow-up, with a target HbA1c of 6% or lower. Patients had diabetes for about 8.5 years, and more than half were taking 3 or more antidiabetic medications.

The 3-year nonophthalmic primary and secondary outcomes were recently presented at the American College of Cardiology meeting and simultaneously published. Mean HbA1c dropped by 1.1% from 9.0% at baseline in those who got medical therapy, by 2.8% from 9.3% in the gastric-bypass group, and by 2.7% from 9.5% in the sleeve-gastrectomy patients.

The trial was also designed to measure ophthalmic outcomes at baseline and at 2 years and 5 years, as secondary outcomes.

About 80% of the patients had no evidence of retinopathy at baseline. From baseline to 2 years, there was no significant change in retinopathy scores for patients who had no retinopathy or mild to severe nonproliferative retinopathy or proliferative retinopathy, for patients who had received each of the 3 treatments.

Dr. Singh said that in all honesty, longer-term follow-up will be needed to properly gauge the effect of bariatric surgery on diabetic retinopathy. Progressing from mild to severe diabetic retinopathy is “typically a process that would potentially occur anywhere from 10 to 15 years [out], but it can be shorter depending on how bad sugar control really is,” he explained.

“If HbA1c is, for example, 11%, 12%, or 13%, those patients can progress twice as fast as those with HbA1c of 6% or 7%. It [also] depends on the length of time a patient has diabetes.”

The 5-year data from STAMPEDE should shed more light on this microvascular outcome, he concluded.

Dr. Singh noted that the trial was designed to test the safety and efficacy of each of the 3 procedures in terms of weight loss and glycemic control. The study also included an assessment of patient-reported outcomes and quality of life. “We are very excited about the results of the trial,” he said. “It’s a very important study.”
It shows that bariatric surgery is safe and effective in treating type 2 diabetes. It’s a very large, well-designed study, and it shows that bariatric surgery is not just a weight-loss procedure. It’s also a diabetes-control procedure.”
Dr. Singh noted that the trial showed that gastric bypass was associated with the greatest weight loss, but the difference between gastric bypass and gastric banding was not significant.

What is Bariatric Surgery?

Bariatric Surgery is a surgery to help morbidly obese patients lose weight. It is a last resort that is should be done only when other methods of weight loss have been tried and have failed. Surgery is not recommended for people with a body mass index (BMI) of 35 or lower.

Bariatric surgery is not the same as gastric bypass. Gastric bypass is a more extreme procedure that involves removing most of the stomach and part of the small intestine. Gastric bypass is a very effective way to lose weight, but it has a lot of risks and complications.

Bariatric surgery is done laparoscopically, which means it is done through several small incisions in the abdomen. The surgery is performed under general anesthesia.

Who Can Have Bariatric Surgery?

Bariatric surgery is usually recommended for people who have a BMI of 40 or higher. A BMI of 40 is considered morbidly obese. If you are morbidly obese, you are at risk for many health problems. These include: Heart disease, High blood pressure, Diabetes, Cancer, Kidney problems, Osteoarthritis and Sleep apnea.

The best way to prevent diabetic retinopathy and diabetic macular edema is to prevent or control your diabetes. Click here to know more.

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