HonorHealth Research Institute aims to be the first research facility in the country to launch a new clinical trial aimed at using steam energy to improve the lining of the gastrointestinal tract to control type 2 diabetes without drugs.
Type II diabetes is a metabolic disorder that occurs when the body becomes resistant to insulin or when the pancreas cannot produce enough insulin. As a result, blood sugar levels rise, which can lead to serious health complications if not properly managed.
The planned minimally invasive endoscopic surgery, called the Restore-1 clinical trial, involves using steam to refresh the mucous membrane, or lining, of the first few inches of the small intestine, also known as the duodenum. As the mucous membrane grows, the patient is theoretically able to return to natural control of blood sugar levels.
Dr. James Swain, medical director of the institute’s Obesity Medicine/Gastrointestinal Research Division and principal investigator overseeing the Restore-1 study, said early studies show that the regenerated mucosa may restore digestive function in patients and reset the body’s blood sugar control.
This technology aims to prevent patients from progressing to insulin-dependent diabetes. ”
Dr. James Swain, MD, principal investigator overseeing the Restore-1 study
Similar techniques to resurface the duodenum are used to treat type 2 diabetes and promote weight loss.
“Because the steam can reach smaller areas, this treatment should be more completely applicable,” Dr. Swain said. “We believe this treatment should be more thorough, more effective, and easier to perform.”
After ablation, or removal of unhealthy tissue, patients receive dietary guidance and meet with a doctor in the clinic at weekly, three-month, and six-month intervals. They will consult with staff by phone on the second and 14th day. Staff will monitor patients’ health during the study, which can last up to eight months.
Participation is free, but all tests, procedures and clinical visits will be paid for by the study’s sponsor, Aqua Medical, a Santa Ana, Calif., medical device manufacturer.
Who is targeted by this study?
Participants must have had type 2 diabetes that is not adequately controlled with current medications, diet, and exercise for at least 1 year. You must be between 22 and 65 years old, BMI between 24 and 40, not currently taking insulin, and HbA1c between 7.5 and 10%.
The main causes of type 2 diabetes are:
- Insulin resistance: The body’s cells do not respond effectively to insulin, causing blood sugar levels to rise.
- Obesity: Excess body fat, especially around the abdomen, increases the risk of insulin resistance.
- Genetics: Having a family history of diabetes may increase your chances.
- Age: Risk increases with age, especially if you are over 45.
- Lack of exercise: A sedentary lifestyle contributes to weight gain and insulin resistance.
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HonorHealth Institute
