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DMR for Type 2 Diabetes(REVITALIZE 1 Trial)
N/A
Recruiting
Research Sponsored by Fractyl Health, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects with type 2 diabetes on stable doses of 20-100 units of total daily insulin dose of basal insulin or basal insulin combined with short-acting insulin and up to 3 permitted non-insulin antidiabetic agents
Glycosylated hemoglobin A1c (HbA1c) of 7.5-10%
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upbaseline 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.
Eligible Conditions
- Type 2 Diabetes
REVITALIZE 1 Trial Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
People with type 2 diabetes who take a certain amount of insulin every day and may also take up to 3 other non-insulin medications for their diabetes.
Select...
Your HbA1c level is between 7.5% and 10%.
Select...
Your body mass index (BMI) is between 24 and 40.
Select...
You are between 21 and 70 years old.
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
Incidences and event rates of hypoglycemic events - 1
Incidences and event rates of hypoglycemic events - 2
Incidences and event rates of hypoglycemic events - 3
+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 Health, Inc.Lead Sponsor
1 Previous Clinical Trials
18 Total Patients Enrolled
Fractyl Laboratories, Inc.Lead Sponsor
5 Previous Clinical Trials
249 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are not pregnant or breastfeeding if you are female, and if you are male, you are eligible.People with type 2 diabetes who take a certain amount of insulin every day and may also take up to 3 other non-insulin medications for their diabetes.Your HbA1c level is between 7.5% and 10%.Your body mass index (BMI) is between 24 and 40.You have a history of type 1 diabetes or very low fasting plasma C-peptide levels.You are taking a type of medication for diabetes that is not allowed in this study, except for certain specified medications.You have had frequent or severe yeast infections in your urinary tract or genitals, or a recent history of urinary or genital infections in the past month.Your liver enzyme levels are more than three times the normal limit.You have type 1 diabetes or had ketoacidosis recently.You have a type of diabetes that can lead to high levels of ketones in your body.You have had diabetic sores that haven't healed or have had a body part removed due to diabetes.You have had more than one very low blood sugar episode or you are not able to feel when your blood sugar gets too low in the past 6 months.You have a specific type of autoimmune disease that affects your intestines.You have a poorly controlled underactive thyroid.You have had thyroid cancer or uncontrolled hyperthyroidism in the past year.You have a history of esophagus problems, including difficulty swallowing, chest pain related to the esophagus, or severe acid reflux that is not well controlled with medication.You have a known stomach condition like ulcers, chronic gastritis, or hernias.You have had ongoing or recent issues with your pancreas.You have active hepatitis B or C, cirrhosis, or liver disease within the last 6 months, or chronic alcoholic or autoimmune hepatitis.You have gallstones or kidney stones that are causing symptoms, or you have acute cholecystitis.You currently have a serious infection in your body.You had cancer that was actively growing or improving within the last 5 years.You have a current bleeding condition in your stomach or intestines.You have a condition that affects the production or lifespan of your red blood cells.You are taking blood thinners or medications that prevent blood from clotting.You have taken strong steroid medication for more than 10 days in a row within the last 90 days.You have experienced new or worsening signs of heart disease in the last 3 months.You have a serious condition affecting the blood vessels in your arms or legs.You have important heart rhythm problems shown on an ECG.You are currently in a weight-loss program and not in the part where you are trying to keep the weight off.You cannot have deep sedation or general anesthesia for medical reasons, or have risks that make these treatments unsafe.You have a history of using illegal drugs or abusing alcohol.You are currently taking medication to help you lose weight.You are taking dietary supplements or herbal products that might affect your blood sugar or increase the risk of bleeding.You haven't been following your treatment plan for the past 6 months.You had a serious case of COVID-19 and still have ongoing long-term symptoms from it.You had stomach or intestine surgery that might make it hard to treat the upper part of your small intestine.You are taking medications that affect how your stomach and intestines work.You have a history of serious kidney problems or are on dialysis.Your blood sugar level is higher than 270 mg/dL on two different visits.You have symptomatic heart failure that needs medication to control symptoms.You are between 21 and 70 years old.You have an uncontrolled hormone condition, except for type 2 diabetes.You are at risk of getting pancreatitis.Your body mass index (BMI) is between 24 and 40.Your average blood sugar level, measured by HbA1c, is between 7.5% and 9.5%.Your blood sugar level is between 180 to 270 mg/dL after fasting overnight for 8 hours and not taking glargine for 24-36 hours.You are between 21 and 70 years old.You are of child-bearing potential (WOCBP) and you must agree to use two of the established contraceptive methods throughout the study duration.You are able to sign an informed consent form and comply with study requirements.People with type 2 diabetes who are taking metformin and up to 2 other diabetes medications, and need to take a certain amount of insulin.
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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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, Californian New York City or Mills Peninsula Health Center in San Mateo, California."
Answered by AI
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 diabetesd all suffer from type 2 diabetes mellitus and be non pregnant nor lactating women."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Who else is applying?
What state do they live in?
New Jersey
Other
California
Texas
How old are they?
65+
18 - 65
What site did they apply to?
Mayo Clinic Arizona
University of California San Diego
Baylor St. Luke's Medical Center
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
2
3+
0
Why did patients apply to this trial?
This one close to home. I’m trying to get my A2C down. I am taking metformin ony and last bmi was 432.
PatientReceived 1 prior treatment
I think I need to change my medication. DawnBarrera.
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Baylor St. Luke's Medical Center: < 48 hours
Average response time
- < 2 Days
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