Comparing Obesity-Centric Approach and Usual Care in T2D and Obesity

Medications recently approved for weight loss have introduced new approaches to obesity and Type 2 diabetes (T2D) and have helped many people achieve results previously out of reach. As conditions shift, however, it is important to continue to seek data, refine medical decision making and educate patients about treatment options.

When it comes to T2D, treatment has traditionally focused on controlling glucose to remedy complications of diabetes, says Cleveland Clinic endocrinologist Marcio Griebeler, MD. Significant changes in recent years are sparking new conversations about treatment of T2D and overweight. Obesity is a contributing factor in more than 90% of T2D cases.

“There are new medications and there is an epidemic of obesity,” says Dr. Griebeler. “We are seeing many more patients with diabetes, so we need to ask whether we are treating the main problem or only the complications. Should we focus on blood sugars or treating the route cause — obesity?”

In a randomized control trial (EMPOWER-T2D) from July 2020 to August 2022, researchers from Cleveland Clinic’s Endocrinology & Metabolism Institute compared three approaches to managing weight and glycated hemoglobin (HbA1c) in people with T2D and obesity.

A total of 74 Cleveland Clinic employees with obesity (body mass index ≥ 30 kg/m2) and Type 2 diabetes (HbA1c > 7.5%) were randomized to receive one of the following protocols:

Usual care for T2D. These participants received an initial consultation with an endocrinologist and were medically managed for Type 2 diabetes, hypertension and hyperlipidemia. Their follow-up visits took place every three months for the first year.

Weight management (WMP). Participants took part in Cleveland Clinic’s Integrated Weight Management Program, which consists of an initial evaluation by an obesity medicine specialist to establish a plan of care followed by participation in shared medical appointments (SMAs) every month for the first year for management not only of diabetes but also diabetes. SMAs were run by an obesity specialist and a nutritionist and lasted 75 to 90 minutes.

Weight management plus anti-obesity medication (AOM). These patients participated in the WMP and also were prescribed one of five medications for obesity treatment: orlistat, phentermine/topiramate, naltrexone/bupropion, liraglutide 3.0 mg, or semaglutide 2.4 mg. Notably, newer generation weight loss drugs were not widely available when the study began.

Weight loss and reduction in HbA1C were the primary study outcomes. Over 12 months, the WMP+AOM group lost the most weight and showed statistically significant improvement compared to the usual care group.

Mean weight loss for each group was:

Usual care: 4.5%
WMP: 6.7%
WMP+AOM: 8.7%

The proportion of participants who achieved HbA1c < 7% at the one-year mark was 57% in the usual care group, 71% in the WMP group and 46% in the WMP+AOM group. The study found that the WMP+AOM approach was noninferior to the usual care.

Mean reduction in HbA1c for each group:
Usual care: 1.7%
WMP: 2.2%
WMP+AOM: 2.2%

Confounding elements

The study was terminated earlier than planned. COVID-19 caused recruitment and retention problems, and the introduction of a new generation of weight loss drugs changed treatment plans for many patients.

“We started having so many new medications approved for diabetes that also treat obesity,” says Dr. Griebeler. “The ‘usual care’ became almost an obesity-centric approach as we were treating these patients, which became confounding for the study.”

The final sample size was four times smaller than planned. However, sufficient statistical power remained to identify a significantly greater decrease in body weight in the group using the weight management program plus anti-obesity medication than in the group using the usual care.

Patient education is key

With the evolution of obesity medications and positive reports about their effects on weight and diabetes-related factors, education becomes important for managing patient expectations.

“These medications are very important. They are very effective in treatment obesity in addition to diabetes, cause weight loss, and treat its comorbidities,” says Dr. Griebeler. “Also, due to metabolic adaptations, all patients at some point will reach a weight plateau and further weight loss is more difficult to achieve.

“If these new medications are stopped, hunger may come back and weight regain is also seen. These medications are great tools to facilitate control of diabetes and obesity, however the basics can’t be forgotten. Patients need to eat quality food, engage in physical active, protect muscle mass loss, take care of stress and sleep well.

“So there are many things we can do,” he adds. “Our message clearly should state that these drugs are not magic pills — that you take them and forget about everything else. You still need to do the other things.”