HonorHealth Research Institute is looking to become the first research facility in the nation to begin a new clinical trial that aims to modify the lining of the digestive tract with the use of steam energy to control type II diabetes without the use of drugs.
Type II diabetes is a metabolic disorder that occurs when the body becomes resistant to insulin or when the pancreas fails to produce enough insulin. The result is elevated blood sugar levels, which can lead to serious health complications if not managed properly.
Called the Restore-1 clinical trial, this planned minimally invasive, endoscopic procedure calls for the use of steam to refresh the mucosa, or lining, of the first several inches of the small intestine also known as the duodenum. As the mucosa grows back, patients theoretically would return to natural control of their blood-sugar.
Initial research indicates that the regrown mucosa may restore patients' digestive functions and resets the body's control of blood sugar, said James Swain, M.D., medical director of the Research Institute's Bariatrics/GI Research Division and the principal investigator supervising the Restore-1 study.
This technique is designed to prevent patients from advancing to insulin-dependent diabetes."
Dr. James Swain, M.D., principal investigator supervising the Restore-1 study
Similar technologies involving the resurfacing of the duodenum have been used to treat type 2 diabetes and encourage weight loss.
"The application of this therapy should be more complete with steam because it can reach into small areas," said Dr. Swain. "We believe that this treatment should be more thorough, more effective and easier to be performed."
Following the ablation, or removal of unhealthy tissue, patients would receive dietary instructions, and meet in clinic with their doctor at intervals of 1 week, 3 months and 6 months. They would consult with staff by phone on days 2 and 14. Staff would monitor the patients' health throughout the study, which could last for up to 8 months.
Participation is free, with all tests, procedures and clinical visits paid for by the study's sponsor, Aqua Medical, a Santa Ana, Calif., medical equipment manufacturer.
Who is eligible for this study?
Participants must have had type 2 diabetes for at least one year that is not adequately controlled with current medications, diet and exercise. They must be aged 22-65, have a body mass index of 24-40, are not currently taking insulin, and have an HbA1c of 7.5-10%.
Primary causes of type 2 diabetes include:
- Insulin Resistance: The body's cells do not respond effectively to insulin, leading to higher blood sugar levels.
- Obesity: Excess body fat, particularly around the abdomen, increases the risk of insulin resistance.
- Genetics: Family history of diabetes can increase the likelihood.
- Age: The risk increases with age, particularly for those over 45 years old.
- Physical Inactivity: A sedentary lifestyle contributes to weight gain and insulin resistance.
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