Status:
COMPLETED
Cryovagotomy Diabetes Trial
Lead Sponsor:
Emory University
Conditions:
Diabetes Type 2
Diabetes Mellitus
Eligibility:
All Genders
22-65 years
Phase:
NA
Brief Summary
The pilot study will assess the feasibility and efficacy of cryoablation procedure to freeze the vagus nerve in obese patients with type 2 diabetes. Aim 1 will focus on changes in glycemic control. Ai...
Detailed Description
Obesity is a growing epidemic, currently affecting over 1/3 of the adult US population and is a well-established risk factor for the development of diabetes and cardiovascular disease. Given that the ...
Eligibility Criteria
Inclusion
- Males and females between the ages of 22-65
- Diagnosis of type 2 diabetes mellitus (T2DM) for \<10 years
- HbA1c between ≥7.5% and ≤10.5%
- 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
- BMI 30-40 kg/m\^2
- Willing to comply with study requirements
- Documented negative pregnancy test in women of child bearing potential and use of an effective birth control method
- Average score of ≥3 on questions 4, 8, 9, 13, and 14 from the Three Factor Eating Questionnaire
Exclusion
- Diagnosis of type 1 diabetes or history of diabetic ketoacidosis
- Use of insulin therapy
- Significant kidney disease (eGFR \< 60 ml/min/1.73m\^2)
- Current drug or alcohol addiction
- 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
- Systemic steroid use within 30 days prior to randomization
- Use of prescription or over the counter weight loss medications within 6 months prior to randomization
- Weight gain/loss \>5% over the past 6 months
- Previous GI surgery or abnormal GI anatomy which may limit technical feasibility of the procedure
- Recent diagnosis of cardiovascular disease requiring percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) within the past 6 months
- 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
- Any condition or major illness that places the subject at undue risk by participating in the study
- Psychiatric condition rendering the subject unable to understand the possible consequences of the study
- Inability to provide informed consent
- 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
- 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
- Active or recent infection
- Immunosuppression
- 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)
- History of blood pressure instability (systolic BP ≤100 or ≥160 mmHg)
- History of autonomic dysfunction, including amyloidosis, Parkinson's disease, autoimmune disease, spinal cord injury
Key Trial Info
Start Date :
October 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 8 2022
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04276051
Start Date
October 23 2020
End Date
February 8 2022
Last Update
March 8 2023
Active Locations (5)
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1
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
2
Emory University Hospital
Atlanta, Georgia, United States, 30322
3
Grady Health System
Atlanta, Georgia, United States, 30322
4
The Emory Clinic
Atlanta, Georgia, United States, 30322