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 18 and 70 years old
• People who were diagnosed with type 2 diabetes at least 6 months before joining the trial
• People whose glycated hemoglobin (a blood sugar marker, also called HbA1c) is between 7.5% and 10.5%
• People with a BMI between 27 and 40 kg/m²
• People who, in the 12 weeks before screening, were taking 2 to 3 diabetes tablets but still had poorly controlled blood sugar levels and are able to keep taking the same medications throughout the trial — or people whose blood sugar has not been well controlled despite changes to their lifestyle
• People whose body weight has been stable, meaning it has changed by less than 5% in the 5 weeks before screening
• People who agree not to donate blood during the trial
• People who are willing and able to sign an Informed Consent Form, showing they understand the trial's purpose and what it involves
• People who are willing and able to follow all trial requirements, including attending scheduled visits and following lifestyle guidelines
• Women who could become pregnant must have a negative pregnancy test at screening and must use contraception throughout the trial

Who may not be able to join:

• People diagnosed with type 1 diabetes
• People who have had severe diabetes complications such as diabetic ketoacidosis or a hyperosmolar non-ketotic coma
• People with a fasting C-peptide level below 1 ng/mL (a measure of insulin production) (confirm with trial site)
• People who have used any type of insulin for more than 1 month in the past two years (not counting insulin used for gestational diabetes during pregnancy)
• People who have had one or more severe low blood sugar episodes in the past 6 months that required another person's help to manage
• People currently using a GLP-1 receptor agonist or a dual GLP-1/GIP agonist (a type of injectable or oral diabetes medication)
• People with a known autoimmune disease
• People who have had previous stomach or bowel surgery that changed the structure of the digestive tract, such as gastric bypass or gastric banding
• People with known structural or functional problems in the upper digestive tract that could make it harder for a device to pass through or increase the risk of injury during a camera procedure, such as strictures, varicose veins in the oesophagus, or large pouches in the digestive tract
• People with a history of gastroparesis (a condition where the stomach empties too slowly)
• People who have had an acute gastrointestinal illness in the past 7 days
• People with a history of irritable bowel syndrome, radiation enteritis, Crohn's disease, coeliac disease, or other inflammatory bowel conditions
• People with a history of chronic or acute pancreatitis (inflammation of the pancreas)
• People with active hepatitis, active liver disease, or liver enzyme levels (ALT) more than 3 times the upper limit of normal at screening
• People currently taking blood-thinning medications such as warfarin or other oral anticoagulants that cannot safely be stopped
• People currently taking certain blood-thinning medications called P2Y12 inhibitors (such as clopidogrel, prasugrel, or ticagrelor) that cannot be stopped at least 7 days before the procedure
• People who cannot stop taking non-steroidal anti-inflammatory drugs (NSAIDs, such as ibuprofen) for at least 4 weeks after the treatment (paracetamol and low-dose aspirin are permitted as alternatives)
• People who have taken systemic steroid medications (not including topical, eye, or inhaled forms) continuously for more than 12 days within the 10 weeks before screening
• People currently using medications known to affect how the digestive tract moves
• People currently using prescription or over-the-counter weight-loss medications
• People who have taken part in a structured weight-loss program or endoscopic weight-loss procedure within 6 months of screening
• People with persistent anaemia, defined as a haemoglobin level below 10 g/dL
• People with known conditions affecting haemoglobin (such as sickle cell anaemia or haemolytic anaemia) that could interfere with HbA1c test results
• People who have donated or received blood in the 3 months before screening
• People with unstable or irregular heart rhythm
• People who have had a heart attack, stroke, or been hospitalised for heart failure in the 6 months before screening
• People with a history of heart valve disease or chronic heart failure classified as NYHA class III or IV (a measure of heart failure severity)
• 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 secondary hypothyroidism or poorly controlled primary hypothyroidism where thyroid levels (TSH) are outside the normal range at screening
• People who have a non-removable electronic implanted device, such as a pacemaker
• People who have a stent in the duodenum or bile duct
• People who have medical reasons that prevent them from safely having an upper gastrointestinal camera procedure or intravenous anaesthesia
• People currently diagnosed with cancer, or who have had cancer in the past 5 years (certain treated skin cancers or treated cervical carcinoma in situ with no recurrence for at least 3 months may still be eligible — confirm with trial site)
• Women who are breastfeeding
• People currently enrolled in another clinical trial
• People with binge eating disorder, or a history of severe or uncontrolled kidney, blood, hormonal, heart, lung, joint, nerve, psychiatric, or metabolic conditions, or any other condition the investigator considers makes participation unsafe
• People who are critically ill or whose life expectancy is less than 5 years

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