Type 2 Diabetes Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged between 22 and 65 years old
• People who have been diagnosed with type 2 diabetes
• People whose HbA1c blood sugar level is between 7.5% and 10% (a measure of average blood sugar over time)
• People with a BMI (body mass index) between 30 and 50
• People who have not been able to bring their HbA1c below 7.5% after at least 3 months on a stable combination of two or more diabetes medications (such as insulin, metformin, or others)
• People who are willing and able to follow all study requirements
• People who have at least one year of medical records available, including details of their diabetes medications and doses
• Women who could become pregnant must have a negative pregnancy test on record and must be using an approved form of birth control for the entire time they are in the trial
• People who have read and signed the official consent form for the study

Who may not be able to join:

• People who have previously been treated with the RESET System (the device used in this trial)
• People who have had previous stomach or bowel (gastrointestinal) surgery, or who have an unusual bowel anatomy, that could interfere with placing or using the RESET Liner device
• People who have had a severe low blood sugar episode or a serious diabetes-related emergency (such as DKA or HHNK) requiring help from another person in the last 6 months
• People with a known history of liver disease (such as viral or autoimmune liver disease, or significant liver scarring — though incidental fatty liver alone does not disqualify)
• People whose kidneys are not functioning well enough (eGFR below 45 ml/min/1.73m²) (confirm with trial site)
• People who have previously been hospitalised, needed IV antibiotics, or required drainage for an abscess
• People who have had surgery or procedures on their liver or bile ducts (such as bile duct widening or stent placement)
• People with type 1 diabetes, or any history of diabetic ketoacidosis (a serious diabetes complication)
• People with a fasting C-peptide level below 1.0 ng/mL (a blood test related to insulin production)
• People with triglyceride (blood fat) levels above 600 mg/dL
• People with a Vitamin D deficiency (level below 20 ng/ml)
• People with bleeding problems, low platelet counts, or blood clotting disorders
• People shorter than 5 feet (152.4 cm) in height
• People with a current addiction to alcohol, or current use of addictive drugs such as narcotics, opiates, or benzodiazepines
• People with a history of pancreatitis (including gallstone-related pancreatitis, even if the gallbladder has since been removed)
• People diagnosed with osteopenia or osteoporosis, or currently taking certain bone medications (such as bisphosphonates, denosumab, romosozumab, or teriparatide)
• People diagnosed with an autoimmune connective tissue disorder such as lupus or scleroderma
• People with active or recent (within the past 12 months) gastroesophageal reflux disease (GERD), unless it is being treated with H2 blockers (not proton pump inhibitors/PPIs)
• People with uncontrolled thyroid disease, a history of thyroid cancer, overactive thyroid, or who are taking thyroid hormone for any reason other than an underactive thyroid — TSH levels must be between 0.4 and 4
• People currently taking blood-thinning or anti-clotting medications within 10 days before joining the trial, or who are expected to need them during the trial
• People currently taking, or expected to need during the trial, any of the following: proton pump inhibitors (PPIs), systemic steroids, medications that affect gut movement (e.g. metoclopramide), prescription or over-the-counter weight loss drugs, anti-inflammatory medications including NSAIDs, aspirin, or ibuprofen, or medications known to cause significant weight changes (e.g. chemotherapy drugs)
• People currently taking supplements known to increase bleeding risk, including Ginkgo biloba, Ginseng, Vitamins C and E, Turmeric, St. John's Wort, Evening Primrose Oil, Feverfew, or Green Tea Extract
• People with an active H. pylori infection (a type of stomach bacteria)
• People with a history of Crohn's disease, bowel blockages (atresias), or untreated narrowings (stenoses) of the bowel
• People with current stomach or bowel problems such as ulcers or recent upper gastrointestinal bleeding (within 3 months of joining)
• People who have lost 5% or more of their total body weight in the 3 months before joining the trial
• People with a positive FIT (Fecal Immunochemical Test) result at the time of screening (a stool test used to check for bowel health)
• People with a psychological condition or behaviour that could make it difficult to follow the treatment and follow-up plan
• People without access to a working telephone and internet connection for follow-up calls and electronic diary entries
• People who have donated blood or received a blood transfusion in the 90 days before their baseline blood tests, or who are unwilling to avoid blood donation during the study
• People with any condition that causes faster-than-normal red blood cell turnover, such as thalassemia
• People found to carry certain specific bacteria (Pseudomonas aeruginosa, Stenotrophomonas maltophilia, or Klebsiella pneumoniae types K1 and K2) at levels above a certain threshold (confirm with trial site)
• People with a known sensitivity (allergy) to nickel or titanium
• People who are not suitable for MRI scans, or whose MRI safety status is not appropriate for the area being scanned
• People with a history of, or suspected, coronary artery disease (heart disease affecting the arteries of the heart)
• People with poor dental health that prevents them from chewing food properly
• People currently enrolled in another clinical trial (within the past 3 months) — observational studies are permitted
• People living in an area without ready access to the trial site's medical resources
• People the lead investigator determines to be at undue risk for any other reason

Important: Always verify eligibility with the trial site directly before applying.