Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2025-12-24 @ 7:56 PM
NCT ID:
NCT06385704
Eligibility Criteria:
Inclusion Criteria:
\- 1.25-65 years of age. 2.Diagnosed with type 2 diabetes. 3.Glycated Hemoglobin (HbA1c) of 7.5 - 10.0% (59-86 mmol/mol). 4.Body Mass Index (BMI) ≥ 24 and ≤ 40 kg/m2. 5.Currently taking one or more oral glucose lowering medications, with no changes in dose or medication in the previous 12 Weeks prior to study entry.
6.Able to comply with study requirements and understand and sign the informed consent.
Exclusion Criteria:
1. Clinical diagnosis of type 1 diabetes.
2. Current use of Glucagon-like peptide-1 (GLP-1) analogues.
3. Hypoglycemia unawareness or a history of severe hypoglycemia.
4. Clinical diagnosis of autoimmune disease.
5. Previous gastrointestinal surgery that could affect the ability to treat the duodenum.
6. Use of anticoagulation therapy (such as warfarin) which cannot be discontinued for 7 days before and 14 days after the procedure.
7. Clinical diagnosis of anemia.
8. Not potential candidates for surgery or general anesthesia.
9. Participating in another ongoing clinical trial of an investigational drug or device.
10. Any other mental or physical condition which, in the opinion of the Investigator, makes the subject a poor candidate for clinical trial participation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
65 Years
Study:
NCT06385704
Study Brief:
Protocol Section:
NCT06385704