Obesity 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 between 21 and 65 years old
• People with a body mass index (BMI) between 30 and 50 (a measure of weight relative to height)
• People who are willing to make significant changes to their eating habits and lifestyle as required by the study
• People who have tried non-surgical weight loss methods in the past without lasting success
• People who are willing to follow all study requirements, including signing a consent form, attending regular check-up visits, completing blood tests, filling out a quality-of-life questionnaire, and taking part in a supervised diet and behaviour change program
• People who live close enough to the study site to attend all required follow-up visits
• People who are able to understand and agree to participate in the study
• Women who could become pregnant must agree to use an appropriate form of contraception during the study
• The trial includes specific spots reserved for people who have high blood pressure managed with two or more blood pressure medications (well controlled for at least 6 months), and for people with type 2 diabetes managed with tablets only (not insulin) with a blood sugar level measure called HbA1c at or below 9, also for at least 6 months before joining (confirm with trial site for how these spots affect eligibility)

Who may not be able to join:

• People who have had previous surgery on the upper digestive tract, stomach, or oesophagus (except a straightforward gallbladder or appendix removal)
• People who have had complications from prior digestive surgery, such as blockages or known internal scarring (adhesions)
• People who have previously had any weight loss (bariatric) surgery
• People who have had any surgery on the oesophagus, stomach, or for a hiatal hernia
• People with inflammatory conditions of the digestive tract, such as Crohn's disease, stomach ulcers, Barrett's oesophagus, oesophagitis, or gastrointestinal cancer
• People with conditions that could cause bleeding in the upper digestive tract, such as enlarged veins in the oesophagus or stomach, or certain abnormal blood vessel formations
• People with a mass or polyp larger than 1 cm in the stomach
• People with a hiatal hernia larger than 4 cm, or severe or hard-to-manage acid reflux symptoms
• People with a structural abnormality in the oesophagus or throat (such as a narrowing or pouch) that could make passing a camera scope difficult
• People with achalasia or any other severe condition affecting how the oesophagus moves food
• People with significant blood clotting problems or who are taking blood-thinning medication
• People with insulin-dependent diabetes (type 1 or type 2), those likely to need insulin within the next 12 months, or those with an HbA1c above 9
• People with diabetes who have been treated with GLP-1 medications and have already lost 5% or more of their body weight on that treatment
• People who stopped GLP-1 diabetes/weight medications within the past 3 months and have not yet regained at least 80% of the weight they lost while on that medication
• People with a serious health condition unrelated to their weight that would make an endoscopy (camera procedure) higher risk
• People with ongoing chronic abdominal pain
• People with movement or motility disorders of the digestive tract, such as gastroparesis (delayed stomach emptying) or severe constipation
• People with liver failure or cirrhosis
• People who have previously had an intragastric (stomach balloon) device
• People with active psychological conditions that would prevent participation in a lifestyle modification program, as assessed by a psychologist
• People who are unwilling to take part in a supervised diet and behaviour change program with regular medical follow-up
• People who take high-dose aspirin (more than 80 mg daily), anti-inflammatory medications, blood thinners, or other medications that can irritate the stomach lining on a daily basis
• People who are unable or unwilling to take a prescribed stomach acid-reducing medication (proton pump inhibitor)
• People who are pregnant or breastfeeding
• People with severe heart or lung disease, a history of coronary artery disease, a heart attack within the past 6 months, poorly controlled high blood pressure, or who require regular use of anti-inflammatory pain medications (NSAIDs)
• People taking medications that must be taken at very specific time intervals and could be affected by changes in how quickly the stomach empties, such as certain anti-seizure or heart rhythm medications
• People taking corticosteroids (steroids), immunosuppressant medications, or strong pain medications (narcotics)
• People currently taking diet pills or weight loss supplements
• People with symptomatic heart failure, irregular heart rhythm, or unstable coronary artery disease
• People with pre-existing lung conditions such as chronic obstructive pulmonary disease (COPD), pneumonia, or lung cancer
• People diagnosed with an autoimmune connective tissue disorder (such as lupus or scleroderma) or who have a weakened immune system
• People with a specific genetic condition such as Prader-Willi syndrome
• People with eating disorders, including binge eating disorder, bulimia, night eating syndrome, or compulsive overeating
• People with an uncontrolled thyroid or other hormone condition known to affect weight

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