Safety and Effectiveness of Endoscopic Intestinal Re-Cellularization Therapy in Individuals With Type II Diabetes

NCT06267391 | Recruiting DMC FDA Device

• 1 other identifier: 898
• Study Type: interventional
• Target: 264
• Locations: 2 countries
• Sites: 45

Brief Summary

This study is designed to evaluate the safety and effectiveness of endoscopic intestinal re-cellularization therapy in individuals with type 2 diabetes (T2D) inadequately controlled on non-insulin glucose-lowering medications.

Conditions

Type 2 Diabetes Mellitus; Type2diabetes; Diabetes Mellitus, Type 2; Diabetes; Type 2 Diabetes

Keywords

Diabetes; Type 2 Diabetes; Duodenal Mucosal Resurfacing

Outcome Measures

Primary Outcomes (1)

• HbA1c

  Change in HbA1c (%) from baseline to Month 6

  6 months post-procedure

Secondary Outcomes (5)

• HbA1c

  12 months post-procedure

• HbA1c ≤7.0% without requiring rescue medication

  6 months post-procedure

• Time-in Range (TIR)

  6 months post-procedure

• Total body weight loss (%TBWL)

  6 months post-procedure

• Incidence of adverse events

  6 months post-procedure

Study Arms (2)

ReCET Arm

EXPERIMENTAL

Treatment Arm will receive the ReCET procedure.

Device: ReCET Treatment

Control Arm

SHAM COMPARATOR

Control Arm will receive a sham procedure.

Device: Sham Procedure

Interventions

ReCET Treatment DEVICE

Treatment arm will receive the ReCET therapy. The ReCET procedure utilizes the ReCET catheter to deliver non-thermal pulsed electric field to the first portion of the small intestine (duodenum) to induce cell regeneration. The catheter is introduced to the duodenum through the mouth using a guide wire and the therapy is applied to treat the duodenum. Participants will be followed for 12 months post procedure.

Also known as: duodenal mucosal resurfacing

ReCET Arm

Sham Procedure DEVICE

The Control arm will receive a sham procedure. The sham procedure consists of placing the ReCET catheter as described above without therapy applied. Participants will be followed for 12 months post procedure and will be offered cross-over to receive the ReCET therapy after 12 months.

Control Arm

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Endogenex, Inc.: lead

Study Sites (45)

University of Alabama

Birmingham, Alabama, 35205, United States

RECRUITING

Central Alabama Research

Birmingham, Alabama, 35209, United States

RECRUITING

Velocity Clinical Research, Gardena

Gardena, California, 90247, United States

RECRUITING

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

UCLA

Los Angeles, California, 90065, United States

RECRUITING

Hoag Memorial Hospital Presbyterian - Digestive Health Institute

Newport Beach, California, 92663, United States

RECRUITING

Velocity Clinical Research, Panorama City

Panorama City, California, 91402, United States

WITHDRAWN

Velocity Clinical Research, Hallandale Beach

Hallandale, Florida, 33009, United States

RECRUITING

Mayo Clinic

Jacksonville, Florida, 32224, United States

RECRUITING

Universal Axon Clinical Research LLC

Miami, Florida, 33166, United States

RECRUITING

University of Miami

Miami, Florida, 33166, United States

RECRUITING

Quantum Clinical Research

Miami Beach, Florida, 33140, United States

RECRUITING

West Orange Endocrinology

Ocoee, Florida, 34761, United States

RECRUITING

Advent Health

Orlando, Florida, 32804, United States

RECRUITING

Orlando Health

Orlando, Florida, 32806, United States

RECRUITING

Health Synergy Clinical Research

West Palm Beach, Florida, 33407, United States

RECRUITING

NorthShore University Health System

Evanston, Illinois, 60201, United States

RECRUITING

Heartland Medical Research, Inc.

Clive, Iowa, 50325, United States

RECRUITING

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, 50266, United States

RECRUITING

John Hopkins

Baltimore, Maryland, 21287, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Cooper Health System

Camden, New Jersey, 08103, United States

RECRUITING

Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

RECRUITING

The Ohio State University- Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

Velocity Clinical Research - Austin

Austin, Texas, 78613, United States

RECRUITING

Dell Medical School

Austin, Texas, 78712, United States

RECRUITING

IMA Clinical Research - Austin

Austin, Texas, 78745, United States

RECRUITING

The University of Texas Health Science Center at Houston

Bellaire, Texas, 77401, United States

RECRUITING

Velocity Clinical Research, Dallas

Dallas, Texas, 75230, United States

RECRUITING

Southwest Medical Center

Dallas, Texas, 75235, United States

RECRUITING

University of Texas Southwestern Medical School - William P. Clements Jr. University Hospital

Dallas, Texas, 75235, United States

RECRUITING

Epic Medical Research

DeSoto, Texas, 75115, United States

RECRUITING

Houston Methodist Research Institute

Houston, Texas, 77030, United States

RECRUITING

Juno Research, LLC

Houston, Texas, 77054, United States

RECRUITING

Texas Diabetes & Endocrinology, P.A.

Round Rock, Texas, 78681, United States

RECRUITING

Diabetes & Glandular Disease Clinic, P.A.

San Antonio, Texas, 78229, United States

RECRUITING

IMA Clinical Research - San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Mt. Olympus Medical Research

Sugar Land, Texas, 77479, United States

RECRUITING

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2006, Australia

RECRUITING

The BMI Clinic

Double Bay, New South Wales, 2028, Australia

RECRUITING

Royal North Shore Hospital

Saint Leonards, New South Wales, 2065, Australia

RECRUITING

Eastern Health - Box Hill Hospital

Box Hill, Victoria, 3128, Australia

RECRUITING

St Vincent's Hospital Melbourne

Fitzroy, Victoria, 3065, Australia

RECRUITING

Austin Health

Heidelberg, Victoria, Australia

RECRUITING

Baker Heart and Diabetes Institute

Melbourne, Victoria, 3004, Australia

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Lian Cunningham, MD, PhD

  lcunningham@endogenex.com

  STUDY DIRECTOR

Central Study Contacts

Marie Steinbrink, MS

CONTACT

(763) 251-6827; recetstudy@endogenex.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The participants randomized in a 2:1 ratio to the ReCET treatment arm or the sham control arm.

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 20, 2024
• Study Start: May 1, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (7); US (38)