Printed from Voxsanity (voxsanity.com.au) — NCT07197788 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
Back to Type 2 Diabetes
Type 2 Diabetes Trial, By Invitation
NCT07197788
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- People who were in the sham (inactive) control group of the ReCET Study and completed their 12-month check-up visit.
- People whose HbA1c (a measure of average blood sugar over time) is between 7.0% and 10.5%.
- People with a body mass index (BMI) below 40 kg/m².
- People who agree not to donate blood while taking part in the study.
- People who are able to follow the study requirements and are willing to read and sign a consent form.
- Women who could become pregnant must not be pregnant at the time of joining, and must use an accepted form of contraception throughout the study.
- People who are willing and able to attend all required study visits and complete all required study tasks.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People who have been diagnosed with type 1 diabetes.
- People who have a history of diabetic ketoacidosis (a serious diabetes complication) or hyperosmolar nonketotic coma (another serious diabetes-related emergency).
- People who are currently using insulin, or who have used any type of insulin for more than one month at any point in the last 2 years (except insulin used during pregnancy).
- People who have hypoglycemic unawareness, meaning they cannot feel the warning signs when their blood sugar drops too low.
- 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 (a type of diabetes or weight management medicine) within 6 months before the screening visit, after having used 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 disorders, or who test positive for a specific antibody called anti-GAD.
- People who have previously had stomach or bowel surgery that changed the structure of their digestive system or could limit treatment of the upper small intestine (such as certain types of gastric bypass or gastric band surgery).
- People with a known structural or functional problem in the upper digestive tract that could make it harder to pass a device through or increase the risk of injury during an endoscopic procedure (such as narrowing, varicose veins in the food pipe, or certain disorders of 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 (sudden) gastrointestinal illness in the past 7 days.
- People with a known history of irritable bowel syndrome, radiation enteritis, or inflammatory bowel disease such as Crohn's disease or celiac disease.
- 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 the normal range, except that people with non-alcoholic fatty liver disease (NAFLD) whose ALT is within 3 times the upper limit of normal may still be eligible (confirm with trial site).
- People currently taking blood-thinning medications called vitamin K antagonists (such as warfarin) or direct-acting oral anticoagulants, if these cannot be safely paused around the time of the procedure.
- People currently taking certain blood-thinning medications called P2Y12 inhibitors (such as clopidogrel, prasugrel, or ticagrelor) if these cannot be stopped for 7 days before the procedure.
- People who are unable to stop taking anti-inflammatory pain medicines (NSAIDs) from the time of treatment through 4 weeks after the procedure (paracetamol and low-dose aspirin are allowed as alternatives).
- People who have used steroid medications taken by mouth or injection (not skin creams, eye drops, or inhalers) for more than 10 days in a row within the 12 weeks before the screening visit.
- People currently taking medications known to affect how the digestive system moves food through (such as metoclopramide).
- People currently taking prescription or over-the-counter weight loss medications, or who have stopped taking such medications within the past 6 months.
- People who have taken part in a structured weight loss program or had an endoscopic weight loss procedure within 6 months of the screening visit.
- People with persistent anaemia, defined as a haemoglobin level below 10 g/dL.
- People with a known history of haemoglobin disorders (such as sickle cell anaemia or other conditions) that are known to interfere with the HbA1c blood test result.
- People who have donated or received blood in the 3 months before the screening visit.
- People with an unstable or irregular heart rhythm condition.
- People who have had any of the following heart or blood vessel events in the 6 months before screening: heart attack, unstable chest pain (angina), stroke, hospitalisation for heart failure, or other significant heart disease (unless a heart specialist and/or the treating endoscopy team has given documented clearance).
- People with a history of heart valve disease or chronic heart failure classified as NYHA stage III or IV (moderate to severe).
- People whose kidneys are not functioning well enough, based on a specific blood test result (eGFR at or below 45 ml/min/1.73m²).
- 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, those who are HIV-positive, or those whose immune status makes them a poor candidate in the opinion of the investigator.
- People with a history of secondary hypothyroidism (underactive thyroid caused by another condition), or poorly controlled primary hypothyroidism (underactive thyroid with abnormal TSH levels at screening).
- People who have implanted electronic devices that cannot be turned off during the procedure.
- People who have stents in their duodenum (upper small intestine) or bile ducts.
- People who are not suitable candidates for an upper gastrointestinal endoscopy or general anaesthesia.
- People with active illicit drug use or alcoholism (regularly drinking more than 2 alcoholic drinks per day).
- People who have had an active cancer diagnosis within the last 5 years (excluding certain non-melanoma skin cancers).
- Women who are currently breastfeeding.
- People who are currently participating in another clinical trial involving an investigational drug or device.
- People with binge eating disorder, or any other mental or physical condition that, in the opinion of the study investigator, makes them a poor candidate for participation in the trial.
- People who are critically ill or whose life expectancy is less than 5 years.
- People who are staff members at the trial site directly involved in this study, or their immediate family members (spouse, parent, child, or sibling, whether biological or legally adopted).
- People with very high blood sugar levels — specifically, fasting levels above 270 mg/dL (15 mmol/L) or random levels above 360 mg/dL (20 mmol/L) confirmed by a second measurement on a different day — at the baseline visit or before the procedure.
- People who experience a severe low blood sugar event between the baseline visit and the procedure visit.
- People with poorly controlled high blood pressure, shown by an average of 3 separate readings above 180 mmHg (top number) or above 100 mmHg (bottom number).
- Women of childbearing potential who have a positive pregnancy test at the baseline visit.
- People found to have a certain level of oesophageal inflammation (LA Grade C or higher) on endoscopy.
- People with abnormalities in the digestive tract that prevent an endoscope from reaching the upper small intestine.
- People with structural abnormalities in the upper small intestine (duodenum) that would prevent the treatment procedure from being completed, including an unusually curved or twisted anatomy.
- People found during endoscopy to have upper digestive tract abnormalities such as ulcers, polyps in the area to be treated, varicose veins, narrowing, or abnormal blood vessel formations.
- People with any other anatomical or endoscopic findings that, in the opinion of the investigator, would make it unsafe to use the investigational device or perform the procedure.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.
If this is close to home
This page includes language about advanced illness, prognosis, or palliative care, because that is how the trial's eligibility criteria are written. Seeing it set out plainly can land hard, whether it is about you or about someone you are caring for. You do not have to be at a crisis point to talk to someone.
- Griefline — grief and loss counselling, 9am to 6pm weekdays and midday to 6pm weekends (AEST/AEDT): 1300 845 745
- Carer Gateway — practical and emotional support if you are caring for someone, 8am to 5pm weekdays: 1800 422 737
- Canteen — for 12 to 25 year olds affected by cancer, their own or a family member's: 1800 945 215
- Palliative Care Australia — directory of palliative care services near you: palliativecare.org.au
- Lifeline — 24/7, for any kind of distress, at any hour the services above are closed: 13 11 14
Palliative care is not the same as giving up on treatment, and it is not only for the last weeks of life. It is symptom and comfort care that can run alongside active treatment, including a clinical trial.
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of support and crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention.
Voxsanity is not a counselling or medical service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
Contact this trial
Australian sites
St. Vincent's Hospital Melbourne, Fitzroy, Victoria
Baker Heart and Diabetes Institute, Melbourne, Victoria
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
By Invitation
Phase
Not Applicable
Sponsor
Endogenex, Inc.
Registry
ClinicalTrials.gov
Start date
1 July 2026
Est. completion
1 October 2027
Where this trial is recruiting
🇦🇺 Australia
🇺🇸 United States
2 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Incidence of adverse events
Can't join this trial?
Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.