The Revitalize-1 Study - Frequently Asked Questions

Frequently Asked Questions

About this Research Study:

You may be able to take part if you:

  • are 21–70 years of age 
  • have been diagnosed with type 2 diabetes 
  • are currently taking insulin

There are additional criteria that are reviewed on this website, and by the study team at the study center at the first visit if you pre-qualify.

The Revitalize-1 Study is looking at a new treatment for people with type 2 diabetes that may eliminate or reduce insulin requirements.

This procedure lasts about 1 hour and acts on the duodenum (the first part of the small intestine located immediately after the stomach). The treatment may eliminate or reduce the need for insulin injections in the future.

The study has two stages and you will be in only one of them.

Stage 1: 70 to 140 patients will be in this stage. All patients in this stage will receive the investigational procedure DMR.

Stage 2: About 420 patients will be in this stage. Patients in this stage will receive either the investigational procedure (DMR) or a sham procedure. A sham procedure does not involve removal of the excess abnormal layer of the first part of the small intestine (duodenum). If you are in Stage 2, you will have a 50% chance of receiving the DMR procedure and a 50% chance of receiving the sham procedure.

The study doctor will let you know which stage you will be in.

If eligible, depending on the stage of the study and the procedure you receive, you will be in the Revitalize-1 Study for about 1 or 2 years. You may be eligible to receive the DMR procedure at a later date if you were randomly assigned to be part of the sham procedure. The study coordinator can answer any questions you have about the study.

This initial appointment is an opportunity for you to:

  • Learn more about the Revitalize-1 Study. You’ll be speaking with a study coordinator at the study center to learn more regarding your potential participation.
  • Ask any important questions you may have. These can be any questions you may have about the Revitalize-1 Study or clinical research in general.
  • Determine if the Revitalize-1 Study may be right for you. After speaking with the study coordinator and learning details about this study, the research staff will perform a series of screening tests to determine if you are eligible to participate. If you’re eligible, you will be given an opportunity to decide if participation is right for you. If you agree to take part, the center will ask you to review and sign a consent form before any study-specific screening tests are completed.

If eligible, you will be in the Revitalize-1 Study for about 1 or 2 years depending on the stage of the study and the procedure you will receive.  The study coordinator can answer any questions you have about the study.

Please do not discontinue any medication unless you are advised to do so by the study center staff or your primary care physician.

The study centers are located throughout the United States and Europe.

There is no cost to you for participating in this study.  If you qualify for this study, you may be compensated for time and travel, which will vary by study center.  Participants also receive all study-related care and tests at no cost to them.  

This research study is designed to test the investigational procedure for safety and effectiveness. One or more of the answers that you provided were outside of the eligibility criteria for this trial. This does not mean you will not qualify for different research studies.

About Research Studies:

A research study (also known as a clinical trial) is a medical study that is designed to answer questions about the safety of potential new drugs or procedures and to find out how well they work. These studies must be performed before a potential new medication or treatment can be approved for use in patients.

It is important to test drugs and medical devices in the people they are meant to help. It is also important to conduct research in a variety of people because different people may respond differently to treatments.

For each research study, researchers develop eligibility criteria, such as age, gender, previous treatment history, and other medical conditions to help determine who can safely participate in the study. Not everyone who applies for a research study will be accepted. Participants will be selected based on the eligibility criteria and the number of participants needed by the researchers.

Research studies are used to test medications and medical devices/procedures before they are sold to the general public. The testing that takes place during the studies provides information regarding the safety and effectiveness of the potential treatment/procedure. 

One way to find information about clinical trials is by searching this website: www.clinicaltrials.gov. ClinicalTrials.gov is an interactive online database, managed by the National Library of Medicine. It provides information about both federally and privately supported clinical research. ClinicalTrials.gov is updated regularly and offers information on each trial's purpose, who is qualified to participate, locations, and phone numbers to call for more information.

For those who are qualified, taking part in research studies offers several benefits:

  • Getting actively involved in their own health care
  • Having access to potential new procedures 
  • Having access to specialists working on the condition being studied
  • Helping others by contributing to medical research

It is important to test drugs and medical products in the people they are meant to help. It is also important to conduct research in a variety of people because different people may respond differently to treatments. 

For each research study, researchers develop eligibility criteria, such as age, gender, previous treatment history, and other medical conditions. Not everyone who applies for a research study will be accepted. Volunteers may be excluded based on the eligibility criteria and/or the number of participants needed by the researchers.

Research studies can be sponsored by an organization such as a pharmaceutical company, a medical device company, a federal agency such as the Veterans Administration, or an individual, such as a physician or health care provider. The sponsor determines the location(s) of the trials, which are usually conducted at universities, medical centers, clinics, doctor's offices, and/or at hospitals.

The government requires researchers to give prospective participants complete and accurate information about what will happen during the study. Participants must sign an "informed consent" form before joining the study, indicating they understand that the study is research, and that they can leave the research study at any time. This informed consent helps ensure that a prospective research study participant understands what’s involved.

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