Percutaneous CT-guided Cryoablation of the Splanchnic Nerves

Withdrawn before enrolling · Not applicable

Conditions studied: Type 2 Diabetes

In brief

The purpose of this study is to evaluate the safety and effectiveness of freezing (cryoablation) of the splanchnic nerve for management of diabetes. The splanchnic nerves carry signals from the brain to help regulate the way organs function. Quieting these signals, by freezing the splanchnic nerves, may help the body regulate blood sugar. The study procedure will take about 30 minutes and the researchers hope that it will help people to control their blood sugars, lose weight, and possibly improve blood pressure.

Key facts

Study ID

NCT04569721

Run by

Emory University

People needed

0

Starts

2021-02-19

Expected to finish

2022-02-01

Last updated by the study team

2021-07-28

Who can join

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

You may qualify if…

• Diagnosis of Type 2 diabetes mellitus (T2DM) for <10 years
• HbA1c between ≥7.5% and ≤10.5%
• Willing to comply with study requirements
• Subjects have failed lifestyle interventions as a first line treatment
• Body mass index (BMI) between 30 and 37

You may not qualify if…

• Diagnosis of type 1 diabetes or history of diabetic ketoacidosis
• Thyroid disease unless on stable medications for >3 months
• Systemic steroid use within 30 days
• Use of prescription or over the counter weight loss medications within 6 months prior to 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
• Positive pregnancy test at time of cryoablation procedure
• 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 autonomic dysfunction, including amyloidosis, Parkinson's disease, autoimmune disease, spinal cord injury
• History of heart failure
• History of macro-occlusive vascular disease
• Glomerular filtration rate (GFR) < 60 mL/min/1.73 m2
• History of abnormal pulmonary function or pulmonary intervention (e.g., thoracotomy, thoracentesis, pneumothorax, or thoracic trauma)
• History of or current substance abuse
• Weight gain or loss of >5% during the six months preceding enrollment
• Use of any antihyperglycemic agents aside from metformin or sulfonylurea therapy

Where it is running

• Emory Johns Creek Hospital — Johns Creek, Georgia, United States

Full record on ClinicalTrials.gov

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