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DMR for Type 2 Diabetes (REVITALIZE 1 Trial)
N/A
Recruiting
Research Sponsored by Fractyl Laboratories, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male, and non-pregnant, non-lactating females
Age between 21 and 70 years (both inclusive)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 24
Awards & highlights
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.
Who is the study for?
Adults aged 21-70 with Type 2 Diabetes, using insulin and certain other diabetes medications, who have a BMI of >24 to ≤40 kg/m^2. Participants should not be pregnant or breastfeeding and must use reliable contraception. They cannot have stomach disorders, severe kidney disease, recent heart issues, uncontrolled thyroid conditions, or a history of significant alcohol/substance abuse.Check my eligibility
What is being tested?
The trial is testing the Revita® System's Duodenal Mucosal Resurfacing (DMR) procedure against a sham (fake) procedure to see if it improves blood sugar control and heart health in those whose diabetes isn't well-managed by insulin alone. Participants will either receive DMR or the sham treatment and be monitored for up to 48 weeks.See study design
What are the potential side effects?
Potential side effects may include discomfort at the procedure site, digestive issues such as nausea or bloating, risks associated with sedation used during the procedure like allergic reactions or breathing difficulties, bleeding from where tissue was treated, and possible infection.
REVITALIZE 1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man or a woman not pregnant or breastfeeding.
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I am between 21 and 70 years old.
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I have type 2 diabetes, take metformin and up to 2 other diabetes medications, and need 20-60 units of insulin daily.
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I am a woman who can have children, not pregnant, and agree to use two forms of birth control during the study.
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I am a man or a woman not pregnant or breastfeeding.
Select...
I am between 21 and 70 years old.
Select...
I have type 2 diabetes and take 20-100 units of insulin daily, along with up to 3 other diabetes medications.
REVITALIZE 1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Demonstrate superiority of Revita DMR to sham in improving glycemic control
Secondary outcome measures
Demonstrate superiority of Revita DMR to sham in achieving target HbA1c at 24 weeks
Demonstrate superiority of Revita DMR to sham in elimination of insulin use at 24 weeks
Demonstrate superiority of Revita DMR to sham in fasting glucose at 24 weeks
+2 moreREVITALIZE 1 Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Duodenal Mucosal Resurfacing (DMR)Active Control1 Intervention
Duodenal Mucosal Resurfacing (DMR) treatment will include hydrothermal ablation of the duodenal muscosa in an upper endoscopic procedure in patients with type 2 diabetes on insulin.
Group II: Duodenal Mucosal Resurfacing Sham (Sham)Placebo Group1 Intervention
Duodenal Mucosal Resurfacing Sham (Sham) treatment will include an upper endoscopic procedure similar to DMR treatment without hydrothermal ablation of the duodenal mucosa in patients with type 2 diabetes on insulin.
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Who is running the clinical trial?
Fractyl Laboratories, Inc.Lead Sponsor
5 Previous Clinical Trials
249 Total Patients Enrolled
Fractyl Health, Inc.Lead Sponsor
1 Previous Clinical Trials
18 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Duodenal Mucosal Resurfacing (DMR)
- Group 2: Duodenal Mucosal Resurfacing Sham (Sham)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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.
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT04419779 — N/A
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