Cryovagotomy Diabetes Trial

Completed · Not applicable

Conditions studied: Diabetes Type 2, Diabetes Mellitus, Obesity

In brief

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. Aim 2 will evaluate differences in body weight and anthropometric measurements. This study will provide much needed data for a novel therapeutic intervention to manage obese patients with type 2 diabetes.

Key facts

Study ID

NCT04276051

Run by

Emory University

People needed

5

Starts

2020-10-23

Expected to finish

2022-02-08

Last updated by the study team

2023-03-08

Who can join

Age: 22 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Emory University Hospital Midtown — Atlanta, Georgia, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Grady Health System — Atlanta, Georgia, United States
• The Emory Clinic — Atlanta, Georgia, United States
• Emory Johns Creek Hospital — Johns Creek, Georgia, United States

Full record on ClinicalTrials.gov

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