Electric zaps to the gut could help control type 2 diabetes

NCT ID NCT06267391

Disease control Sponsor: Endogenex, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 06, 2026 · Updated 2 times

Summary

This study tests a device called ReCET that delivers gentle electric pulses to the first part of the small intestine. The goal is to trigger cell regeneration and improve blood sugar control in people with type 2 diabetes who are not on insulin. Participants are randomly assigned to receive either the real procedure or a sham (placebo) procedure, and their blood sugar levels and weight are tracked for 12 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: ReCET catheter (delivers non-thermal pulsed electric field to the duodenum)
What this could lead to: If it works, this could offer a new, non-drug way to help people with type 2 diabetes better control their blood sugar and possibly reduce their need for diabetes medications.
What could go wrong: This is an early-stage study, so the treatment may not prove effective or safe in the long term. The procedure involves risks from endoscopy and the electric pulses, such as bleeding or injury to the intestine.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

350 people

The number who actually took part.

Started

May 2024

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 22- 70 years of age, inclusive. * T2D diagnosis for at least 6 months. * HbA1C of 7.5-10.5%, inclusive, determined by the central laboratory. * BMI 27-40 kg/m2, inclusive. * On 2-4 non-insulin glucose lowering mediations or on monotherapy with either GLP-1 or GLP-1/GIP medications, with no changes in medication or dosing for at least 12 weeks prior to the baseline visit. * Individualized metabolic surgery (IMS) score ≤ 95. * Weight stability (≤5% weight change) for at least 12 weeks prior to the screening visit. * Agree not to donate blood during participation in the study. * Able to comply with study requirements and understand and sign the Informed Consent Form. * Women of childbearing potential must be not pregnant and using an acceptable method of contraception throughout the study. * Willing and able to comply with study visits and study tasks as required per protocol. Exclusion Criteria: * Diagnosed with type 1 diabetes. * History of diabetic ketoacidosis or hyperosmolar nonketotic coma. * Fasting serum C-peptide \<1 ng/mL (333pmol/l). * Current use of insulin, or previous use of any types of insulin for \>1 month at any time (except for treatment of gestational diabetes) in last 2 years. * Hypoglycemic unawareness. * History of ≥1 severe hypoglycemia episode in past 6 months * Discontinuation of a GLP-1RA or a GLP-1/GIP dual-agonist within 6 months of the screening visit following at least one month of treatment. * Known autoimmune disease, including but not limited to, celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder, or as evidenced by a positive anti-glutamic acid decarboxylase (GAD) test. * Previous GI surgery that has changed GI anatomy or could limit treatment of the duodenum, such as Billroth 2, Roux-en-Y gastric bypass, gastric band or other similar procedures or conditions. * Known history of a structural or functional disorder of the upper GI tract that may impede passage of the device through the upper GI tract or increase risk of tissue damage during an endoscopic procedure, including eosinophilic esophagitis, stricture/stenosis, varices, diverticula, or other disorder of the esophagus, stomach and duodenum. * History of gastroparesis. * Acute gastrointestinal illness in the last 7 days. * Known history of irritable bowel syndrome, radiation enteritis or other inflammatory bowel disease, such as Crohn's disease and Celiac disease. * History of chronic or acute pancreatitis. * Active hepatitis or active liver disease, or alanine aminotransferase (ALT) level \>3.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory at screening visit. Patients with NAFLD are eligible if their ALT level is ≤3.0 times the ULN. * Current use of vitamin K antagonists, such as warfarin, or current use of direct-action oral anticoagulants (DOCAs) that cannot be safely discontinued periprocedurally. * Current use of P2Y12 inhibitors (clopidogrel, prasugrel, ticagrelor) that cannot be discontinued for 7 days before the procedure. * Unable to discontinue non-steroidal anti-inflammatory drugs (NSAIDs) from treatment through 4 weeks following the procedure. Alternative use of acetaminophen and low dose aspirin 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 screening visit. * Use of medications known to affect GI motility (e.g. metoclopramide/ Reglan) * Current use of weight loss medications such as Saxenda \[liraglutide \], Xenical® \[orlistat\], Acutrim® \[phenylpropanolamine\], Sanorex® \[mazindol\], Adipex® \[phentermine\], BELVIQ® \[lorcaserin\], Qsymia® \[phentermine/topiramate combination\], Contrave® \[naltrexone/bupropion\], or other weight loss medications including over-the-counter \[OTC\] medications \[for example, Allī®\]) or have discontinued weight loss medications within 6 months. * Participation in any structured weight loss program or endoscopic weight loss intervention within 6 months of the screen visit. * Persistent anemia, defined as hemoglobin \<10 g/dL. * Known history of hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c. * History of blood donation or transfusion within 3 months prior to the Screening Visit. * Unstable or paroxysmal cardiac arrhythmia. * Any of the following cardiovascular conditions within 6-months prior to screening visit: acute myocardial infarction, cerebrovascular accident (stroke), hospitalization due to congestive heart failure. * History of valvular heart disease or chronic heart failure (NYHA III or IV). * Estimated glomerular filtration rate (eGFR) ≤ 45 ml/min/1.73m2 calculated by CKD-EPI Creatinine Equation as determined by the central laboratory. * Known immunocompromised status, including but not limited to individuals who have undergone organ transplantation, chemotherapy, or radiotherapy within the past 12 months, who have clinically significant leukopenia, who are positive for the human immunodeficiency virus (HIV) or whose immune status makes the participant a poor candidate for clinical trial participation in the opinion of the investigator. * History of secondary hypothyroidism or inadequately controlled primary hypothyroidism (TSH value outside the normal range at screening). * Presence of any implanted electronic devices that cannot be turned off during the procedure * Presence of duodenal or biliary stents. * Not a candidate for upper GI endoscopy or general anesthesia. * Active illicit substance abuse or alcoholism (\>2 drinks/day regularly). * Active malignancy within the last 5 years (excluding non-melanoma skin cancers). * Women who are breastfeeding. * Participating in another ongoing clinical trial of an investigational drug or device. * Binge eating disorder, or any other mental or physical condition which, in the opinion of the study investigator, makes the participant a poor candidate for clinical trial participation. * Critically ill or has a life expectancy \<5 years. * Are investigator site personnel directly affiliated with this study and/or their immediate family member. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes Diabetes mellitus type 2 Type 2 diabetes Type 2 diabetes mellitus TYPE2DIABETES

Contacts and locations

Locations

Advent Health

Orlando, Florida, 32804, United States
Austin Health

Heidelberg, Victoria, Australia
Baker Heart and Diabetes Institute

Melbourne, Victoria, 3004, Australia
Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States
Central Alabama Research

Birmingham, Alabama, 35209, United States
Cooper Health System

Camden, New Jersey, 08103, United States
Dell Medical School

Austin, Texas, 78712, United States
Diabetes & Glandular Disease Clinic, P.A.

San Antonio, Texas, 78229, United States
Eastern Health - Box Hill Hospital

Box Hill, Victoria, 3128, Australia
Epic Medical Research

DeSoto, Texas, 75115, United States
Health Synergy Clinical Research

West Palm Beach, Florida, 33407, United States
Heartland Medical Research, Inc.

Clive, Iowa, 50325, United States
Hoag Memorial Hospital Presbyterian - Digestive Health Institute

Newport Beach, California, 92663, United States
Houston Methodist Research Institute

Houston, Texas, 77030, United States
IMA Clinical Research - Austin

Austin, Texas, 78745, United States
IMA Clinical Research - San Antonio

San Antonio, Texas, 78229, United States
Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, 50266, United States
John Hopkins

Baltimore, Maryland, 21287, United States
Juno Research, LLC

Houston, Texas, 77054, United States
Mayo Clinic

Jacksonville, Florida, 32224, United States
Mayo Clinic

Rochester, Minnesota, 55905, United States
Mt. Olympus Medical Research

Sugar Land, Texas, 77479, United States
NorthShore University Health System

Evanston, Illinois, 60201, United States
Orlando Health

Orlando, Florida, 32806, United States
Quantum Clinical Research

Miami Beach, Florida, 33140, United States
Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States
Royal North Shore Hospital

Saint Leonards, New South Wales, 2065, Australia
Royal Prince Alfred Hospital

Camperdown, New South Wales, 2006, Australia
Southwest Medical Center

Dallas, Texas, 75235, United States
St Vincent's Hospital Melbourne

Fitzroy, Victoria, 3065, Australia
Texas Diabetes & Endocrinology, P.A.

Round Rock, Texas, 78681, United States
The BMI Clinic

Double Bay, New South Wales, 2028, Australia
The Ohio State University- Wexner Medical Center

Columbus, Ohio, 43210, United States
The University of Texas Health Science Center at Houston

Bellaire, Texas, 77401, United States
UCLA

Los Angeles, California, 90065, United States
Universal Axon Clinical Research LLC

Miami, Florida, 33166, United States
University of Alabama

Birmingham, Alabama, 35205, United States
University of Miami

Miami, Florida, 33166, United States
University of Texas Southwestern Medical School - William P. Clements Jr. University Hospital

Dallas, Texas, 75235, United States
Velocity Clinical Research - Austin

Austin, Texas, 78613, United States
Velocity Clinical Research, Dallas

Dallas, Texas, 75230, United States
Velocity Clinical Research, Gardena

Gardena, California, 90247, United States
Velocity Clinical Research, Hallandale Beach

Hallandale, Florida, 33009, United States
West Orange Endocrinology

Ocoee, Florida, 34761, United States

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