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 who are willing and able to give their informed consent to take part in the study
• People aged 25 to 65 years old at the time of giving consent
• People with a BMI between 30 and 50
• People who had a sleeve gastrectomy or other weight-loss stomach surgery more than 12 months ago, and who have type 2 diabetes (with a blood sugar marker called HbA1c above 6.5%) or have regained weight after surgery
• People with type 2 diabetes who have never had stomach or weight-loss surgery, diagnosed between 6 months and 10 years ago, who are taking at least one oral diabetes medication, and whose fasting blood sugar is below 200 mg/dl and HbA1c is above 6.5%
• People who agree not to have any additional weight-loss or body-reshaping surgery for one year during the study

Who may not be able to join:

• People who are pregnant, breastfeeding, or planning to become pregnant in the next 9 to 12 months
• People who are considered vulnerable, such as those with certain mental or physical disabilities, or who are incarcerated
• People currently enrolled in another research study, or who participated in one within the past 30 days
• People who use injectable insulin
• People whose type 2 diabetes is not well controlled
• People who have uncontrolled high blood pressure, high cholesterol or blood fat levels, or untreated sleep apnea
• People who currently use injectable GLP-1 medications (a type of injected diabetes or weight-loss treatment)
• People who show signs of type 1 diabetes or severely reduced insulin production, based on specific blood test results (confirm with trial site)
• People whose digestive tract has an unusual or complicated shape or structure found during a previous internal camera examination or scan
• People who have had surgery on the intestines, colon, or upper small intestine (not counting weight-loss surgery)
• People whose previous surgeries, injuries, implants, illnesses, or genetic conditions could make the procedure unsafe or more difficult, including significant scarring or abnormal anatomy
• People with a history of, or high risk for, certain bowel conditions such as Crohn's disease, other inflammatory bowel disease, coeliac disease, bowel cancer surgery, or internal scar tissue in the abdomen (including from a perforated appendix or Meckel's diverticulum)
• People with severe, hard-to-treat acid reflux (GERD)
• People with a condition called Barrett's oesophagus (a change in the lining of the food pipe)
• People with any physical feature that would block the use of a camera tube and related instruments through the mouth and stomach
• People who have an implanted pacemaker or defibrillator
• People whose overall health condition is considered too high a risk for the procedure, in the opinion of the treating surgeon or anaesthetist
• People who have had small bowel surgery, such as removal of part of the small intestine
• People with an active H. pylori stomach infection (though people who are treated successfully and test negative afterwards may be able to continue screening — confirm with trial site)
• People with a history of chronic or sudden-onset pancreatitis (inflammation of the pancreas)
• People with known active hepatitis or active liver disease
• People with gallstones causing symptoms, kidney stones, or acute gallbladder inflammation
• People with a history of blood clotting problems, or upper digestive tract bleeding conditions such as ulcers, varicose veins in the stomach, narrowing of the digestive tract, or abnormal blood vessel growth in the intestines
• People taking blood-thinning medications (other than aspirin) that cannot be stopped for 7 days before and 14 days after the procedure
• People taking a specific type of blood-thinning medication called P2Y12 inhibitors (such as clopidogrel, prasugrel, or ticagrelor) that cannot be stopped for 14 days before and after the procedure
• People with a history of serious diabetes-related complications, including heart disease, high blood pressure, poor circulation in the legs, diabetic eye disease, or diabetes-related soft tissue infections
• People taking corticosteroids or medications known to affect how the digestive system moves food through (confirm with trial site)
• People currently taking prescription or over-the-counter weight-loss medications
• People with persistent low red blood cell levels (anaemia), specifically a haemoglobin level below 10 g/dL
• People with significantly reduced kidney function, based on a specific blood test result (confirm with trial site)
• People with an active infection anywhere in the body
• People who have received chemotherapy in the past 9 months, have a history of radiation to the abdomen, or have had an active cancer in the past 5 years
• People with active substance misuse or alcohol dependence
• People with unhealed ulcers, bleeding areas, tumours, or other lesions at the site where the device would be placed
• People who are likely to need an MRI scan within the first two months after the procedure
• People with any physical feature that prevents or makes laparoscopic (keyhole) surgery unsafe
• People who had a surgical or medical procedure within 30 days before joining the trial
• People who have another surgical or medical procedure planned within 30 days after the trial procedure
• People who had a stroke or mini-stroke (TIA) within the six months before giving consent
• People with certain blood test results that suggest a higher risk of poor outcomes (confirm with trial site)
• People who are unable to attend follow-up appointments and assessments as required
• People who, in the investigator's judgement, are unlikely to be able to complete all follow-up visits up to one year, for any reason

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