Percutaneous CT-guided Cryoablation of the Splanchnic Nerves

NCT ID: NCT04569721

Last Updated: 2021-07-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-19
• Study Completion Date: 2022-02-28

Brief Summary

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.

Detailed 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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

CT guided splanchnic cryoablation

Obese patients with type 2 diabetes receiving CT guided splanchnic cryoablation.

Group Type: EXPERIMENTAL

CT Guided Splanchnic Cryoablation

Intervention Type: DEVICE

The patient will be sedated and continuously monitored by the anesthesia team, who will be present for the entire procedure. The puncture site will be anesthetized with 1% Lidocaine infiltration. Following tract anesthesia, and utilizing fluoroscopic CT guidance, four cryoablation probes (Ice Rods®) will be advanced, 2 on each side. In addition, a temperature monitoring probe (Boston Scientific, Multipoint 1.5 Thermal Sensor®) will be advanced on each side. The cryoablation process will include a 10-minute freeze, followed by a 3-minute passive thaw, and a brief active thaw to facilitate probe removal. A final scan will be obtained following removal of the probes. After the procedure, a sterile dressing will be applied, and subjects will be monitored for at least 12 hours in an observation bed in the hospital post-procedure.

Interventions

CT Guided Splanchnic Cryoablation

The patient will be sedated and continuously monitored by the anesthesia team, who will be present for the entire procedure. The puncture site will be anesthetized with 1% Lidocaine infiltration. Following tract anesthesia, and utilizing fluoroscopic CT guidance, four cryoablation probes (Ice Rods®) will be advanced, 2 on each side. In addition, a temperature monitoring probe (Boston Scientific, Multipoint 1.5 Thermal Sensor®) will be advanced on each side. The cryoablation process will include a 10-minute freeze, followed by a 3-minute passive thaw, and a brief active thaw to facilitate probe removal. A final scan will be obtained following removal of the probes. After the procedure, a sterile dressing will be applied, and subjects will be monitored for at least 12 hours in an observation bed in the hospital post-procedure.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Georgia Research Alliance

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

John Prologo

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John D Prologo, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory Johns Creek Hospital

Johns Creek, Georgia, United States

Countries

United States

Other Identifiers

STUDY00000619

Identifier Type: -

Identifier Source: org_study_id