Erika Leiker wants to lose weight. She’s set a goal of shedding 30 pounds from her 5-foot, 4-inch, 195-pound frame, but the 36-year-old Brighton resident faces familiar obstacles in her weight-loss quest. Pounds she gained after having two children six years apart have been difficult to take off and keep off. She enjoys eating sweets and carbohydrates. Her job as payroll manager for a school district serving communities northeast of Denver keeps her mostly deskbound.
Like many people, Leiker says she’s tried different ways to lose weight, both on her own and with the help of programs like SlimGenics and Weight Watchers. Long-term success, however, has been elusive, and achieving it isn’t getting easier, Leiker said.
“Losing 30 pounds is totally doable, and I’ve done it before,” she said. “But it’s harder the older you get. Your metabolism slows down and it seems like what I did before to lose weight is what I’m doing now just to maintain the weight.”
Leiker’s weight-loss challenges are familiar, but the path she’s trying now to drop pounds is not. She’s enrolled in a trial at UCHealth University of Colorado Hospital on the Anschutz Medical Campus that tests whether a device commonly used to relieve pain can help people curb their appetite and thereby lose weight.
The focus of the multi-site trial is a TENS (transcutaneous electrical nerve stimulation) unit, which delivers a low-voltage electrical current through the skin. The devices have long been used by physicians, physical therapists and chiropractors to help patients manage acute and chronic pain in various parts of the body. The idea is that the electrical impulses interfere with nerve firings that cause pain.
In the Elira-2 trial, as it’s called, patients also wear a TENS unit as a blocking device – the object in this case being appetite rather than pain. Those in the treatment arm receive a “wearable patch system” from Elira Therapeutics Inc., the St. Louis-based study sponsor. The system consists of a wireless TENS unit and a smartphone with an app that alerts participants when it is time for a therapy session. They adhere the device to a skin patch placed at a spot just below the rib cage and receive 30 minutes of electrical stimulation, twice a day, before meals.
The participants can also use the device for as many as three, five-minute “rescue sessions” if they have cravings, said Chantal Underkofler, manager the University of Colorado Diabetes and Endocrinology Clinical Trials Program. The app restricts participants from exceeding the 75-minute daily maximum for therapy, Underkofler said.
The treatment group also gets counseling from providers at UCH on following a 1,200-calorie diet while recording in diaries changes in their appetite and comments about the tolerability of the therapy sessions. A control arm follows the same regimen but without using the patch system.
Why might a pain-control device spur weight loss? The key is where study participants attach it: the T6 and T7 (thoracic) dermatomes. Dermatomes are areas of skin supplied by a spinal nerve. The theory of the trial is that stimulating these specific dermatomes with electrical impulses causes a bodily reflex that includes constricting the opening to the stomach, thereby reducing the sense of hunger.
The study excludes people with diabetes, but it if it proves successful as a weight loss tool it could be a boon for patients with the disease, said Dr. Neda Rasouli, an endocrinologist and director of the CU Diabetes and Endocrinology Clinical Trials Program. Rasouli is principal investigator for the trial on the Colorado site.
“One of the main problems with diabetes is obesity,” Rasouli said. “We always talk about modifying diet as an effective treatment for diabetes, but it is difficult to promote it only through counseling. If we can find a new intervention to help people with diabetes lose weight, that will help us with managing the disease.”
A low-risk option
The Elira system potentially adds an accessible treatment tool for providers, particularly those with patients who don’t require losing a great deal of weight. It could augment other treatments, including gastric bypass and other bariatric surgeries; endoscopic treatments, such as balloons inserted in the stomach; medications, and of course lifestyle changes like improving diet and exercise.
Rasouli said she’s most interested in the Elira system’s success in reducing appetite and achieving weight loss of more than 5 percent, as a 7 percent loss is a key goal of the national Diabetes Prevention Program. “Anything above 5 percent is significant in reducing the risk of diabetes,” she said.
She added that no side effects except possibly skin irritation accompany the TENS unit treatment, while weight-loss medications carry a variety of unpleasant side effects, including constipation, fatigue and dizziness. If – and she cautioned that the investigation is “very preliminary” – the study yields a side effect-free, effective weight-loss treatment, “it could be a game-changer” for helping people with diabetes, Rasouli said.
It’s too soon to tell if or how much the Elira system will help Erika Leiker in her quest to drop pounds.
In mid-September she had used the unit for eight weeks. She said she’d had no problem following the regimen and had felt mild discomfort from the electrical current only a couple of times. At least for now, though, the results have been mixed.
“I definitely feel less hungry,” Leiker said. “But as of now I’ve only lost 2 or 3 pounds. I haven’t yet seen a huge change as far as the scale goes.”
Yet she also said the counseling and education materials that are part of the trial have helped her to be more conscious of avoiding carbohydrates like the potatoes, pasta and bagels that she loves but that she knows can thwart her weight-loss efforts.
“It’s so hard to get away from things like that,” she said. “I just need to be more conscious of carbs.”
The Elira-2 trial is now recruiting. For more information, contact Jessie Santana at 720-848-6233 or firstname.lastname@example.org.