Percutaneous CT-guided Cryoablation of the Splanchnic Nerves

Emory University

Status

Withdrawn

Conditions

Type 2 Diabetes

Treatments

Device: CT Guided Splanchnic Cryoablation

Study type

Interventional

Funder types

Other

Identifiers

NCT04569721

STUDY00000619

Details and patient eligibility

About

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.

Full description

Type 2 diabetes (T2D) is a disease of pandemic proportion, affecting approximately 425 million adults worldwide. The incidence of T2D is increasing in most countries and it is predicted that by the year 2045, 629 million adults will be diagnosed with T2D worldwide. Chronically elevated sympathetic activity has been shown to contribute to the development of metabolic syndrome and T2D. Overweight/obese individuals demonstrate elevated noradrenaline and metabolite levels relative to lean healthy individuals - this is particularly concerning since long term prospective studies have shown that noradrenaline levels predict future risk of T2D. Furthermore, dysfunctional sympathetic response to glucose loads is demonstrated amongst those with T2D compared to pre-diabetes. Since the greater splanchnic nerve is the main source of sympathetic input to the viscera, the researchers postulate that denervation of the splanchnic nerve would lead to decreased sympathetic tone, thereby improving glycemic control in patients with T2D. To the researchers' knowledge, this would be the first study to evaluate the role of splanchnic cryoablation as a potential therapeutic for T2D and insulin resistance.

Sex

All

Ages

22 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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