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 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT04276051
Eligibility Criteria:
Inclusion Criteria:
1. Males and females between the ages of 22-65
2. Diagnosis of type 2 diabetes mellitus (T2DM) for \<10 years
3. HbA1c between ≥7.5% and ≤10.5%
4. Treatment with non-insulin antidiabetic medications with stable doses for at least 3 months, with failed prior attempts at dietary interventions to optimize diabetes control
5. BMI 30-40 kg/m\^2
6. Willing to comply with study requirements
7. Documented negative pregnancy test in women of child bearing potential and use of an effective birth control method
8. Average score of ≥3 on questions 4, 8, 9, 13, and 14 from the Three Factor Eating Questionnaire
Exclusion Criteria:
1. Diagnosis of type 1 diabetes or history of diabetic ketoacidosis
2. Use of insulin therapy
3. Significant kidney disease (eGFR \< 60 ml/min/1.73m\^2)
4. Current drug or alcohol addiction
5. Thyroid disease unless underlying diagnosis is primary hypothyroidism on stable medications for \>3 months with thyroid stimulating hormone (TSH) in reference range at time of screening visit
6. Systemic steroid use within 30 days prior to randomization
7. Use of prescription or over the counter weight loss medications within 6 months prior to randomization
8. Weight gain/loss \>5% over the past 6 months
9. Previous GI surgery or abnormal GI anatomy which may limit technical feasibility of the procedure
10. Recent diagnosis of cardiovascular disease requiring percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) within the past 6 months
11. Abnormal pathologies or conditions of the GI tract, including peptic ulcers, hiatal hernia, active gallbladder disease, pancreatitis, cirrhosis, inflammatory bowel disease, upper GI bleed within 6 months of randomization
12. Any condition or major illness that places the subject at undue risk by participating in the study
13. Psychiatric condition rendering the subject unable to understand the possible consequences of the study
14. Inability to provide informed consent
15. Female subjects who have been pregnant within 6 months or breast-feeding at time of enrollment into the study, or women who plan to become pregnant within the next 12 months
16. Diagnosis of anemia, red blood cell (RBC) transfusion in the preceding 3 months or expectation to receive transfusion within the next 12 months, or hemoglobinopathies that would affect HbA1c reliability
17. Active or recent infection
18. Immunosuppression
19. History of coagulopathy or high risk for development of deep vein thrombosis (including congestive heart failure, those who are non-ambulatory, active leukemia/lymphoma, prior thrombotic events, family history of thrombosis)
20. History of blood pressure instability (systolic BP ≤100 or ≥160 mmHg)
21. History of autonomic dysfunction, including amyloidosis, Parkinson's disease, autoimmune disease, spinal cord injury
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
65 Years
Study:
NCT04276051
Study Brief:
Protocol Section:
NCT04276051