Actively Recruiting
Safety and Effectiveness of Endoscopic Intestinal Re-Cellularization Therapy in Individuals With Type II Diabetes
Led by Endogenex, Inc. · Updated on 2025-08-12
264
Participants Needed
45
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Safety and Effectiveness of Endoscopic Intestinal Re-Cellularization Therapy in Individuals With Type II Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 22 and 70 years inclusive
- Diagnosed with type 2 diabetes for at least 6 months
- HbA1c between 7.5% and 10.5%, inclusive
- Body mass index (BMI) between 27 and 40 kg/m2, inclusive
- Taking 2 to 4 non-insulin glucose-lowering medications or monotherapy with GLP-1 or GLP-1/GIP medications without changes for at least 12 weeks
- Individualized metabolic surgery (IMS) score less than or equal to 95
- Weight stable with less than or equal to 5% change for at least 12 weeks before screening
- Agree not to donate blood during the study
- Able to understand and sign the informed consent form
- Women of childbearing potential must not be pregnant and must use acceptable contraception during the study
- Willing and able to comply with study visits and procedures
You will not qualify if you...
- Diagnosed with type 1 diabetes
- History of diabetic ketoacidosis or hyperosmolar nonketotic coma
- Fasting serum C-peptide less than 1 ng/mL
- Current or recent insulin use (more than 1 month in last 2 years), except for gestational diabetes
- Hypoglycemic unawareness or severe hypoglycemia episode in past 6 months
- Discontinued GLP-1RA or GLP-1/GIP dual-agonist within 6 months after at least 1 month of treatment
- Known autoimmune diseases or positive anti-glutamic acid decarboxylase test
- Previous gastrointestinal surgery altering anatomy or limiting duodenal treatment
- Structural or functional upper GI tract disorders that may block device passage or increase risk
- History of gastroparesis or recent acute gastrointestinal illness
- Known inflammatory bowel diseases like Crohn's or celiac disease
- History of pancreatitis or active liver disease with elevated liver enzymes
- Use of blood thinners that cannot be safely stopped before procedure
- Unable to discontinue NSAIDs for 4 weeks after procedure
- Use of systemic glucocorticoids for more than 10 days within 12 weeks prior
- Use of medications affecting GI motility
- Use or recent discontinuation of weight loss medications or participation in weight loss programs
- Persistent anemia or hemoglobin disorders affecting HbA1c measurement
- Recent blood donation or transfusion
- Unstable cardiac arrhythmia or recent severe cardiovascular events
- Severe heart failure or valvular heart disease
- Reduced kidney function (eGFR ≤ 45 ml/min/1.73m2)
- Immunocompromised status or recent chemotherapy/radiotherapy
- Uncontrolled thyroid disease
- Presence of implanted electronic devices that cannot be turned off
- Presence of duodenal or biliary stents
- Not suitable for upper GI endoscopy or general anesthesia
- Active substance abuse or alcoholism
- Active cancer within last 5 years (except non-melanoma skin cancer)
- Breastfeeding women
- Participation in another clinical trial
- Binge eating disorder or other conditions making trial participation unsuitable
- Critically ill or life expectancy less than 5 years
- Investigator site personnel or their immediate family members
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 45 locations
1
University of Alabama
Birmingham, Alabama, United States, 35205
Actively Recruiting
2
Central Alabama Research
Birmingham, Alabama, United States, 35209
Actively Recruiting
3
Velocity Clinical Research, Gardena
Gardena, California, United States, 90247
Actively Recruiting
4
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
5
UCLA
Los Angeles, California, United States, 90065
Actively Recruiting
6
Hoag Memorial Hospital Presbyterian - Digestive Health Institute
Newport Beach, California, United States, 92663
Actively Recruiting
7
Velocity Clinical Research, Panorama City
Panorama City, California, United States, 91402
Withdrawn
8
Velocity Clinical Research, Hallandale Beach
Hallandale, Florida, United States, 33009
Actively Recruiting
9
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
10
Universal Axon Clinical Research LLC
Miami, Florida, United States, 33166
Actively Recruiting
11
University of Miami
Miami, Florida, United States, 33166
Actively Recruiting
12
Quantum Clinical Research
Miami Beach, Florida, United States, 33140
Actively Recruiting
13
West Orange Endocrinology
Ocoee, Florida, United States, 34761
Actively Recruiting
14
Advent Health
Orlando, Florida, United States, 32804
Actively Recruiting
15
Orlando Health
Orlando, Florida, United States, 32806
Actively Recruiting
16
Health Synergy Clinical Research
West Palm Beach, Florida, United States, 33407
Actively Recruiting
17
NorthShore University Health System
Evanston, Illinois, United States, 60201
Actively Recruiting
18
Heartland Medical Research, Inc.
Clive, Iowa, United States, 50325
Actively Recruiting
19
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, United States, 50266
Actively Recruiting
20
John Hopkins
Baltimore, Maryland, United States, 21287
Actively Recruiting
21
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
22
Cooper Health System
Camden, New Jersey, United States, 08103
Actively Recruiting
23
Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
24
The Ohio State University- Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
25
Velocity Clinical Research - Austin
Austin, Texas, United States, 78613
Actively Recruiting
26
Dell Medical School
Austin, Texas, United States, 78712
Actively Recruiting
27
IMA Clinical Research - Austin
Austin, Texas, United States, 78745
Actively Recruiting
28
The University of Texas Health Science Center at Houston
Bellaire, Texas, United States, 77401
Actively Recruiting
29
Velocity Clinical Research, Dallas
Dallas, Texas, United States, 75230
Actively Recruiting
30
Southwest Medical Center
Dallas, Texas, United States, 75235
Actively Recruiting
31
University of Texas Southwestern Medical School - William P. Clements Jr. University Hospital
Dallas, Texas, United States, 75235
Actively Recruiting
32
Epic Medical Research
DeSoto, Texas, United States, 75115
Actively Recruiting
33
Houston Methodist Research Institute
Houston, Texas, United States, 77030
Actively Recruiting
34
Juno Research, LLC
Houston, Texas, United States, 77054
Actively Recruiting
35
Texas Diabetes & Endocrinology, P.A.
Round Rock, Texas, United States, 78681
Actively Recruiting
36
Diabetes & Glandular Disease Clinic, P.A.
San Antonio, Texas, United States, 78229
Actively Recruiting
37
IMA Clinical Research - San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
38
Mt. Olympus Medical Research
Sugar Land, Texas, United States, 77479
Actively Recruiting
39
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2006
Actively Recruiting
40
The BMI Clinic
Double Bay, New South Wales, Australia, 2028
Actively Recruiting
41
Royal North Shore Hospital
Saint Leonards, New South Wales, Australia, 2065
Actively Recruiting
42
Eastern Health - Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Actively Recruiting
43
St Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia, 3065
Actively Recruiting
44
Austin Health
Heidelberg, Victoria, Australia
Actively Recruiting
45
Baker Heart and Diabetes Institute
Melbourne, Victoria, Australia, 3004
Actively Recruiting
Research Team
M
Marie Steinbrink, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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