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DMR for Type 2 Diabetes (REVITALIZE 1 Trial)
REVITALIZE 1 Trial Summary
This trial is investigating whether a new diabetes treatment is better than a sham treatment at improving glycemic, hepatic, and cardiovascular outcomes for patients with type 2 diabetes who can't control their blood sugar with insulin therapy.
REVITALIZE 1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowREVITALIZE 1 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.REVITALIZE 1 Trial Design
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- My fasting blood sugar is between 180 and 270 mg/dL after not eating overnight and stopping my usual diabetes medication for 24-36 hours.I have had severe or repeated urinary or genital infections recently.I have an autoimmune disease that affects my small intestine.My thyroid is underactive or not well-controlled.I have a serious condition affecting my esophagus or severe, uncontrolled acid reflux.I have a history of chronic pancreatitis or had acute pancreatitis in the last year.I have been cancer-free for 5 years, except for minor skin cancers or cancers that were completely cured.I have a bleeding disorder or active bleeding in my upper GI tract.I haven't had a heart attack, stroke, or other major heart issues in the last 6 months.I have had new or worsening heart disease symptoms in the last 3 months.You have a heart condition that shows up on an ECG and needs treatment.My recent fasting triglyceride level was over 600 mg/dL, putting me at risk for pancreatitis.I am currently using medication to help me lose weight.I had severe COVID-19, was hospitalized, and still have long-lasting symptoms.I have severe kidney disease or am on dialysis.I have had stomach surgery that might affect treatment near my small intestine.People with a specific type of diabetes called ketosis-prone T2D.I have severe issues with blood flow in my limbs.I am not taking medications that affect stomach movement.I have type 1 diabetes or recently had ketoacidosis.I currently have an active infection in my body.My HbA1c level is between 7.5% and 9.5% after a stable period.Your weight is within a certain range based on your height.You have had more than one severe low blood sugar episode or are unable to tell when your blood sugar is low in the past 6 months.I am a man or a woman not pregnant or breastfeeding.I have type 2 diabetes and take 20-100 units of insulin daily, along with up to 3 other diabetes medications.I have type 2 diabetes, take metformin and up to 2 other diabetes medications, and need 20-60 units of insulin daily.I have anemia, thalassemia, or had a blood transfusion in the last 90 days.I am between 21 and 70 years old.I am on blood thinners that can't be stopped for 5-7 days before a procedure.I am considered high risk for sedation or anesthesia by an anesthesiologist.I have a weakened immune system due to conditions like organ transplant, HIV, or recent cancer treatment.I am not on any diabetes medication except for non-insulin ones.I am a woman who can have children, not pregnant, and agree to use two forms of birth control during the study.I have type 2 diabetes and take 20-100 units of insulin daily, along with up to 3 other diabetes medications.I have a known stomach condition such as an ulcer, hernia, or cancer.You have a history of using illegal drugs or abusing alcohol.I have had non-healing diabetic ulcers or amputations.I have painful gallstones, kidney stones, or inflammation of the gallbladder.I have had thyroid cancer or hyperthyroidism treated in the last year or my hyperthyroidism is not well-controlled.I have not taken steroid pills for more than 10 days in the last 3 months.Your liver enzymes (ALT or AST) are more than 3 times the normal levels.I haven't taken any experimental drugs recently.I have an uncontrolled hormone-related condition, but not type 2 diabetes.Your blood sugar level is higher than 270 mg/dL on two separate visits.Your body mass index (BMI) is between 24 and 40.I am not taking any supplements or herbs that could affect my blood sugar or increase bleeding risks.Your HbA1c level is between 7.5% and 10%.I have type 1 diabetes with very low C-peptide levels.I am currently in a weight-loss program and not just maintaining my weight.I have heart failure that needs medication to manage symptoms.I am a man or a woman not pregnant or breastfeeding.You have not consistently followed your treatment plan in the last 6 months, as confirmed by your doctor or through tests.My HbA1c level is between 7.5% and 10% after a stable 3-week period.I do not have active hepatitis B or C, cirrhosis, recent severe liver disease, or chronic hepatitis from alcohol or autoimmune disease.I am between 21 and 70 years old.You are able to sign an informed consent form and comply with study requirements.
- Group 1: Duodenal Mucosal Resurfacing (DMR)
- Group 2: Duodenal Mucosal Resurfacing Sham (Sham)
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many participants is this experiment accommodating?
"For this study to be successful, 560 individuals that fit the inclusion qualifications must volunteer. These volunteers can register at either Icahn School of Medicine at Mount Sinai in New york City or Mills Peninsula Health Center in San Mateo, California."
Who is eligible to register for this experiment?
"The experiment is open to 560 individuals aged 21 and above, up until 70 years old. Both male and female participants must have a BMI between 24-40 kg/m2. Furthermore, they should all suffer from type 2 diabetes mellitus and be non pregnant nor lactating women."
Are there multiple health care facilities conducting this clinical investigation within the city limits?
"As of now, 29 sites are offering this trial including Icahn School of Medicine at Mount Sinai in New york, Mills Peninsula Health Center in San Mateo, and University of Michigan in Ann Arbor among other locations."
Are there any current enrollment opportunities for this experiment?
"Per the data on clinicaltrials.gov, this research project is still recruiting participants. It was launched March 8th 2021 and revised October 14th 2022."
Does this trial extend to septuagenarian participants?
"To be eligible for this medical trial, applicants must have reached the age of majority and be under 70 years old. Patients younger than 18 are invited to participate in 193 other trials while patients over 65 can take part in 1105 studies."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Most responsive sites:
- Baylor St. Luke's Medical Center: < 48 hours
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