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Tests treatment safety and results for Type-2 Diabetes Mellitus
Official title A U.S. Pilot Human Investigation of RadiofrEquency Vapor Ablation System to Evaluate Safety, TOleRability, and Effectiveness for Proximal Intestinal Mucosal Ablation in Patients With Type 2 Diabetes Mellitus (RESTORE-1 Study)
ClinicalTrials.gov ID: NCT07355270
What this study is testing
- What it's testing
- The purpose of this study is to assess the safety, tolerability and effectiveness of RF vapor ablation of the proximal intestinal mucosa. This study will test the hypothesis that RF vapor ablation will result in improvement in glycemic parameters, without Serious Adverse Events (SAE) or Unanticipated Adverse Device Effects (UADE).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 65
You may be able to join if
- Men and non-pregnant women 22-65 years of age
- Diagnosed with T2DM for at least 1 year and less than or equal to 15 years
- HbA1C of 7.5 - 10% (58-86 mmol/mol)
- BMI ≥ 24 and ≤ 40 kg/m2
- On one or more non-insulin glucose-lowering medications, with no therapeutic changes in medication regimen for at least 12 weeks prior to the...
You likely can't join if
- Diagnosis of Type-1 Diabetes
- History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
- Probable insulin production failure, defined as serum C-peptide of 0.3-0.6 nmol/l.
- Current or previous use of any types of insulin for \>1 month (at any time, except for treatment of gestational diabetes) in the last 2 years.
- Hypoglycemia unawareness as defined by a score of 4 or higher on a Gold score questionnaire suggestive of impaired awareness of hypoglycemia (IAH).
- History of severe hypoglycemia (2 or more severe hypoglycemic event, as defined by need for third-party assistance, in the last 6 months from the...
See the full eligibility criteria
Who can join
- Men and non-pregnant women 22-65 years of age
- Diagnosed with T2DM for at least 1 year and less than or equal to 15 years
- HbA1C of 7.5 - 10% (58-86 mmol/mol)
- BMI ≥ 24 and ≤ 40 kg/m2
- On one or more non-insulin glucose-lowering medications, with no therapeutic changes in medication regimen for at least 12 weeks prior to the screening visit, to ensure stable glycemic control. Note 1: Exception for...
- Agrees to use an additional glucose-lowering treatment (e.g., liraglutide, other OAD except for glyburide), if recommended by the study Investigator in case of persistent hyperglycemia.
- Weight stability (defined as a \< 5% change in body weight) in the 12 weeks prior to the screening visit. Participants should agree to refrain from using over the counter or herbal supplements intended for weight loss...
- Women of childbearing potential must be using at least one acceptable method of contraception throughout the study
- Willing and able to use CGM for the duration of the study and comply with study visits and study tasks as required per protocol.
- Able to comply with study requirements and understand and sign the Informed Consent Form
What rules you out
- Diagnosis of Type-1 Diabetes
- History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
- Probable insulin production failure, defined as serum C-peptide of 0.3-0.6 nmol/l.
- Current or previous use of any types of insulin for \>1 month (at any time, except for treatment of gestational diabetes) in the last 2 years.
- Hypoglycemia unawareness as defined by a score of 4 or higher on a Gold score questionnaire suggestive of impaired awareness of hypoglycemia (IAH).
- History of severe hypoglycemia (2 or more severe hypoglycemic event, as defined by need for third-party assistance, in the last 6 months from the screening visit).
- people with untreated or unstable microvascular complications of diabetes such as retinopathy, nephropathy, and neuropathy. people who have been appropriately treated/monitored and stable for the prior 3 months before...
- Known systemic autoimmune disease that is uncontrolled or requiring steroids or biologics, including a positive anti-glutamic acid decarboxylase (GAD) test. Systemic autoimmune diseases include but not limited to celiac...
- Previous GI surgery that could limit access to the duodenum such as Billroth 2, Roux-en-Y gastric bypass, or other similar procedures or conditions. (Patients who have undergone a laparoscopic sleeve gastrectomy (LSG)...
- History of chronic pancreatitis or a diagnosis of idiopathic acute pancreatitis within the past 12 months.
- Documented history of diabetic gastroparesis confirmed by gastric emptying study.
- Known active hepatitis or liver disease, excluding nonalcoholic steatohepatitis (NASH) and nonalcoholic fatty liver disease (NAFLD).
- Symptomatic gallstones, or acute gastrointestinal illness in the previous 7 days.
- Known history of severe irritable bowel syndrome, radiation enteritis or other inflammatory bowel syndrome, such as Crohn's disease and Celiac disease.
- Alcoholic liver disease, as indicated by ANI\>-0.66 and AUDIT-C questionnaire
- Known history of a structural or functional esophageal disorder that could impede endoscope passage or elevate the risk of esophageal injury during an endoscopic procedure, including but not limited to moderate-severe...
- Presence of upper gastrointestinal conditions, including active ulcers, varices, strictures, congenital or acquired proximal intestinal telangiectasia, active H. pylori infection.
- Current use of anticoagulation therapy (vitamin K antagonists, such as warfarin, or current use of direct-action oral anticoagulants (DOACs) that cannot be safely discontinued peri procedurally
- Current use of P2Y12 inhibitors (clopidogrel, prasugrel, ticagrelor) that cannot be discontinued for 7 days before and 7 days after the procedure.
- Unable to discontinue high-dose non-steroidal anti-inflammatory drugs (NSAIDs) during treatment through 4 weeks following the procedure. Use of acetaminophen and low dose aspirin, PRN over the counter NSAIDs is allowed.
- Use of systemic glucocorticoids (excluding topical or ophthalmic application or inhaled forms) for more than 10 consecutive days within 12 weeks prior to the baseline visit.
- Persistent anemia, defined as hemoglobin \ 6 weeks apart.
- Known history of hemoglobinopathy.
- Known history of blood donation or transfusion within 3 months prior or screening or anticipated blood donation during the study period.
- Significant cardiovascular disease, including known history of valvular heart disease, or myocardial infarction, heart failure, transient ischemic attack, or stroke within 12 months prior to the Screening Visit.
- Mean of 3 separate blood pressure measurements \>180 mmHg (systolic) or \>100 mmHg (diastolic).
- Estimated glomerular filtration rate (eGFR) ≤ 45 ml/min/1.73m2 (estimated by MDRD).
- Known immunocompromised status, including but not limited to: individuals who have undergone organ transplantation, receipt of chemotherapy, or radiotherapy within the past 12 months, clinically significant leukopenia...
- History of secondary hypothyroidism or inadequately controlled primary hypothyroidism (TSH value \>1.5x of the upper limit of normal range at screening)
- In the opinion of the Investigator, the participant is not an appropriate candidate for upper GI endoscopy or general anesthesia.
- Active illicit substance abuse or Alcohol Use Disorder (AUD) (consuming more than 14 drinks per week for men or more than seven drinks per week for women)
- Active malignancy within the last 5 years (excluding non-melanoma skin cancers)
- Women who are currently breastfeeding
- Participating in another ongoing clinical trial of an investigational drug or device.
- Any other physical or mental condition that, in the opinion of the investigator, would make the participant an unsuitable candidate for clinical trial participation.
- Critically ill or has a life expectancy \<3 years.
- Use of a cardiac pacemaker, implantable cardioverter-defibrillator (AICD), duodenal metallic implants, or any other implanted electronic medical devices.
- General contraindications to deep or conscious sedation, general anesthesia, or upper gastrointestinal (GI) endoscopy, including individuals deemed high-risk by an anesthesiologist (e.g., ASA Physical Status...
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Newport Beach, California, United States
- Chapel Hill, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Newport Beach, California, United States; Chapel Hill, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.