Safety and Effectiveness of Endoscopic Intestinal Re-Cellularization Therapy in Individuals With Type II Diabetes
Recruiting · 40 sites across 11 states
Always free
Study care at no cost to you
For your time and travel
Many studies pay you back
Most need no insurance or papers
Legal status usually isn't required; we'll tell you each study's requirements
Interpreters available
Ask for your language
Your choice
Voluntary — you can stop anytime
What is this study?
This study is designed to evaluate the safety and effectiveness of endoscopic intestinal re-cellularization therapy in individuals with type 2 diabetes (T2D) inadequately controlled on non-insulin glucose-lowering medications.
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
This study is designed to evaluate the safety and effectiveness of endoscopic intestinal re-cellularization therapy in individuals with type 2 diabetes (T2D) inadequately controlled on non-insulin glucose-lowering medications.
Who this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •Age 22 to 70 years (inclusive).
- •Have a type 2 diabetes (T2D) diagnosis for at least 6 months.
- •HbA1c (a blood test showing average blood sugar) between 7.5% and 10.5% (inclusive).
- •BMI 27 to 40 kg/m2 (inclusive).
- •Use 2 to 4 non-insulin glucose-lowering medicines, or use one medicine that is a GLP-1 or GLP-1/GIP medicine, with no medication or dose changes for at least 12 weeks before the baseline visit.
🚫 You may not be able to join if…
- •Have type 1 diabetes.
- •Had diabetic ketoacidosis or hyperosmolar nonketotic coma.
- •Have used insulin currently, or used any insulin for more than 1 month at any time (except gestational diabetes treatment) in the last 2 years.
- •Have hypoglycemic unawareness or had 1 or more severe low blood sugar episodes in the past 6 months.
- •Have certain stomach or intestines conditions or prior GI surgeries that change anatomy or could block the device (including problems such as strictures/stenosis, varices, diverticula, or history of gastroparesis).
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults roughly 22–70
- ✓Have Obesity / overweight
- !Some conditions may not be a fit: Fatty liver disease (NASH/MASH), Heart / cardiovascular disease, Kidney disease, Anxiety
- !Not for people who are pregnant or breastfeeding
- !May require a break from current GLP-1 medications
What to expect, step by step
- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
Has this treatment been tested before?
The study team can share what safety testing has been done so far.
What you need to know before you apply
What is this study testing?+
This study is designed to evaluate the safety and effectiveness of endoscopic intestinal re-cellularization therapy in individuals with type 2 diabetes (T2D) inadequately controlled on non-insulin glucose-lowering medications.
Is it safe? Who makes sure of that?+
This is a research study. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
I take a GLP-1 medication (like Ozempic or Wegovy). Can I still join?+
Maybe. This study may ask you to pause certain weight or diabetes medications for a period of time (a 'washout') before joining, or it may be looking for people not currently on them. The coordinator will review your medications with you — don't stop any medication on your own.
Does it cost anything? Will I be paid?+
Study-related care is provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.
Source: ClinicalTrials.gov · NCT06267391 · Locations: Alabama · California · Florida · Illinois · Iowa · Maryland · Minnesota · New Jersey · Ohio · Texas · New South Wales