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CHICAGO -- A novel form of balloon therapy led to weight loss in overweight patients, as well as improvements in markers of metabolic disease, researchers said here.
In a small clinical trial, patients swallowed a capsule containing a balloon designed to inflate in the stomach and reduce the available space for food, according to Hidetoshi Ohta, MD, and Shinichi Katsuki, MD, PhD, both of Otaru Ekisaikai Hospital in Otaru, Japan.
Action Points
- Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
Other bariatric balloons are placed endoscopically and have a special tube to allow them to be filled, Ohta said in a presentation at Digestive Disease Week 2017.
The capsule the 10 patients swallowed contains a balloon, a magnetic valve, a dry ice rod, and a biosoluble plug. It's guided to the stomach using a "smart magnetic paddle," Ohta said, and then the sublimation of the frozen carbon dioxide inflates the balloon.
The magnetic valve allows the balloon to be deflated at any time after the plug dissolves in the stomach, and the apparatus is then small enough to be excreted, he said.
Bariatric balloons and other minimally- or non-invasive approaches to obesity fill an important gap, commented Reem Sharaiha, MD, of Weill Cornell Medicine in New York City, an expert in endoscopic sleeve gastroplasty.
For morbidly obese people, she told ľֱ, the gold standard remains bariatric surgery, although only a fraction of eligible patients follow that route. For those who are less obese, endoscopic and laparoscopic techniques to modify stomach size are more attractive.
But a procedure-free method could be even more attractive, although the current study is still quite small. It would be "another tool in the toolbox," she said.
To be eligible for the study, patients had to have a BMI of at least 27, but the average was about 32, Ohta told ľֱ. Future research will include more patients with higher BMI, he added.
On the weight front, Ohta said, "our results are quite comparable" to reports on other forms of balloon-based therapy -- an average total body weight loss of 12.6% and excess weight loss of 30%.
But Ohta said the study also fills an important data gap: Balloon researchers typically have reported the effect of their interventions on total body weight, he said, but they have not shown effects on markers of metabolic disorders.
Ohta's group specifically looked at a range of metabolic markers and found an average drop of 0.8 in HbA1c level of patients with diabetes; a 20% decrease in blood insulin levels; a reduction of 20 mg/dL in LDL-cholesterol in patients with hyperlipidemia; and a 48% decrease in visceral fat area and a 19% drop in subcutaneous fat area.
Ohta said he was surprised by the impact on visceral fat. "I didn't expect the visceral fat [reduction] so much," he said.
At baseline, most patients had leptin resistance, he said, but the decrease in visceral fat was highly correlated with a decline in leptin levels, leading the researchers to think that the leptin resistance arose from excess visceral fat.
Ohta said the device his group is testing was developed in conjunction with engineers at Kobe University, also in Japan. The research does not have corporate sponsorship, he said.
Disclosures
Ohta disclosed no relevant relationships with industry.
Sharaiha disclosed relevant relationships with Boston Scientific and Apollo Scientific.
Primary Source
Digestive Disease Week 2017
Katsuki S and Ohta H "A new bariatric balloon capsule therapy without a filling tube indicates a reduction in visceral fat and insulin resistance" DDW 2017; Abstract 610.