Type 2 Diabetes Trial, Recruiting

Written by an AI model from the 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 between 22 and 70 years old
• People who have been diagnosed with type 2 diabetes for at least 6 months
• People whose blood sugar control measure (HbA1c) falls between 7.5% and 10.5%, as confirmed by the trial's laboratory
• People with a body mass index (BMI) between 27 and 40
• People currently taking 2 to 4 non-insulin diabetes medications, or taking a single GLP-1 or GLP-1/GIP medication, with no changes to those medications or doses in the last 12 weeks
• People with an "Individualized Metabolic Surgery" score of 95 or below (confirm with trial site)
• People whose weight has stayed within 5% of the same number for at least 12 weeks before screening
• People who are willing not to donate blood during the study
• People who are able to understand and sign the consent form, and follow the study's requirements
• Women who could become pregnant must not currently be pregnant and must be using an accepted form of contraception throughout the study
• People who are willing and able to attend all study visits and complete all study tasks

Who may not be able to join:

• People diagnosed with type 1 diabetes
• People with a history of diabetic ketoacidosis or a serious diabetes-related emergency called hyperosmolar nonketotic coma
• People whose fasting C-peptide level (a marker of insulin production) is below a certain threshold, as measured by blood test
• People currently using insulin, or who have used any form of insulin for more than 1 month at any time in the last 2 years (use during gestational diabetes is an exception)
• People who cannot feel the warning signs of low blood sugar (a condition called hypoglycemic unawareness)
• People who have had one or more severe low blood sugar episodes in the past 6 months
• People who stopped taking a GLP-1 or GLP-1/GIP medication within the last 6 months, after having taken it for at least one month
• People with a known autoimmune disease, including but not limited to celiac disease, lupus, scleroderma, or other autoimmune connective tissue conditions, or who test positive for a specific autoimmune marker (anti-GAD antibody)
• People who have had previous stomach or bowel surgery that changed the structure of their digestive tract (such as gastric bypass or gastric band surgery)
• People with a known structural or functional problem in the upper digestive tract that could make passing a device through it difficult or risky, such as narrowing, swelling of the veins, or pouches in the esophagus, stomach, or upper small intestine
• People with a history of gastroparesis (a condition where the stomach empties too slowly)
• People who have had an acute gastrointestinal illness in the last 7 days
• People with a history of irritable bowel syndrome, radiation enteritis, Crohn's disease, or celiac disease
• People with a history of pancreatitis (inflammation of the pancreas), whether short-term or long-term
• People with active hepatitis or active liver disease, or whose liver enzyme levels (ALT) are more than 3 times the upper limit of normal (people with a fatty liver condition called NAFLD may still be eligible if their ALT is within that limit)
• People currently taking blood-thinning medications such as warfarin or direct-acting oral anticoagulants that cannot safely be stopped around the time of the procedure
• People taking certain blood-thinning medications called P2Y12 inhibitors (such as clopidogrel, prasugrel, or ticagrelor) that cannot be stopped for 7 days before the procedure
• People who are unable to stop taking anti-inflammatory pain medications (NSAIDs) from the time of treatment through 4 weeks after the procedure (paracetamol and low-dose aspirin are permitted)
• People who have used steroid medications taken by mouth or injection for more than 10 days in a row within the 12 weeks before screening (topical, eye-drop, or inhaled steroids are not included in this restriction)
• People currently taking medications known to affect how the digestive tract moves (such as metoclopramide)
• People currently taking prescription or over-the-counter weight loss medications, or who have stopped taking such medications within the last 6 months
• People who have participated in a structured weight loss program or had an endoscopic weight loss procedure within the last 6 months
• People with persistent anaemia, defined as a haemoglobin level below 10 g/dL
• People with a known inherited blood condition affecting haemoglobin, such as sickle cell anaemia, or any other condition known to interfere with HbA1c measurement
• People who have donated or received blood in the 3 months before the screening visit
• People with unstable or irregular heart rhythm (arrhythmia)
• People who have had a heart attack, stroke, or been hospitalised for heart failure within the 6 months before screening
• People with a history of heart valve disease or significant chronic heart failure (classified as NYHA Class III or IV)
• People whose kidneys are not functioning well enough, based on a specific calculation of kidney filtration rate (eGFR at or below 45)
• People with a known weakened immune system, including those who have had an organ transplant, chemotherapy, or radiotherapy in the past 12 months, those with significantly low white blood cell counts, or those who are HIV positive
• People with inadequately controlled or secondary hypothyroidism (an underactive thyroid not within the normal range at screening)
• People with an implanted electronic device that cannot be turned off during the procedure
• People who have a stent in their duodenum or bile duct
• People who are not considered suitable candidates for upper gastrointestinal endoscopy or general anaesthesia
• People with active illicit substance use or who regularly drink more than 2 alcoholic drinks per day
• People with an active cancer diagnosis within the last 5 years (excluding certain non-melanoma skin cancers)
• Women who are currently breastfeeding
• People currently participating in another clinical trial of an investigational drug or device
• People with binge eating disorder, or any other mental or physical condition that the study investigator considers makes someone unsuitable for the trial
• People who are critically ill or have a life expectancy of less than 5 years
• People who work at the trial site or are immediate family members of trial site staff

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