Percutaneous CT-guided Cryoablation of the Splanchnic Nerves

July 22, 2021 updated by: John Prologo, Emory University

Percutaneous CT-guided Cryoablation of the Splanchnic Nerves for the Management of Type 2 Diabetes

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Johns Creek, Georgia, United States, 30097
        • Emory Johns Creek Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CT guided splanchnic cryoablation
Obese patients with type 2 diabetes receiving CT guided splanchnic cryoablation.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: Month 12
The number of participant deaths will be used to assess the safety of the study procedure.
Month 12
Number of Procedure Related Complications
Time Frame: Month 12
Safety will be assessed by examining procedure related complications, such as bleeding, infection, hypotension, pain, cardiac abnormalities, gastrointestinal abnormalities, or endocrine abnormalities.
Month 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Hemoglobin A1c (HbA1c)
Time Frame: Baseline, Months 1, 3, 6, and 12
HbA1c is a measurement of a persons average blood sugar levels over the prior 3 months. A normal value is below 5.7%. Prediabetes is indicated for levels between 5.7% and 6.4%. Diabetes is diagnosed for values of 6.5% and above.
Baseline, Months 1, 3, 6, and 12
Change in Fasting Glucose
Time Frame: Baseline, Day 7, Months 1, 3, 6, and 12
Fasting plasma glucose measures glucose levels after one has fasted for at least 8 hours. Normal values are below 100 mg/dl. Prediabetes is indicated with values between 100 mg/dl and 125 mg/dl. Diabetes is diagnosed when values are at 126 mg/dl and greater.
Baseline, Day 7, Months 1, 3, 6, and 12
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Time Frame: Baseline, Months 1, 3, 6, and 12
HOMA-IR is a measure of insulin resistance and is calculated as insulin (uIU/mL) times glucose (mg/dL), divided by 405. Values under 1.0 indicate optimal insulin sensitivity. Values greater than 1.9 indicate early insulin resistance while values over 2.9 indicate significant insulin resistance.
Baseline, Months 1, 3, 6, and 12
Change in Body Weight
Time Frame: Baseline, Months 1, 3, 6, and 12
Body weight will be measured in kilograms (kg).
Baseline, Months 1, 3, 6, and 12
Change in Waist Circumference
Time Frame: Baseline, Months 1, 3, 6, and 12
Waist circumference will be measured in centimeters (cm).
Baseline, Months 1, 3, 6, and 12
Change in Waist-to-Hip Ratio
Time Frame: Baseline, Months 1, 3, 6, and 12
The waist-to-hip ratio is calculated as waist circumference (cm) divided by hip circumference (cm). A healthy ratio for women is 0.85 or less and a healthy ratio for men is 0.9 or less. Ratios of 1.0 and greater are associated with increased risk for illnesses that are associated with being overweight.
Baseline, Months 1, 3, 6, and 12
Change in Total Cholesterol
Time Frame: Baseline, Months 1, 3, 6, and 12
Measuring cholesterol is a diagnostic tool used for estimating risk of cardiac disease. Total cholesterol levels below 200 mg/dL are considered normal.
Baseline, Months 1, 3, 6, and 12
Change in Low-Density Lipoprotein (LDL)
Time Frame: Baseline, Months 1, 3, 6, and 12
High levels of LDL leads to arteriosclerosis. LDL levels below 100 mg/dL are considered optimal, however, persons with diabetes or cardiac disease are advised to keep levels below 70 mg/dL.
Baseline, Months 1, 3, 6, and 12
Change in High-Density Lipoproteins (HDL)
Time Frame: Baseline, Months 1, 3, 6, and 12
HDL values between 40 and 59 mg/dL are considered normal. HDL values under 40 mg/dL are associated with increased risk of developing heart disease and stroke.
Baseline, Months 1, 3, 6, and 12
Change in Triglyceride Levels
Time Frame: Baseline, Months 1, 3, 6, and 12
Triglycerides levels measure fat in blood and high triglyceride levels are associated with health concerns such as high blood pressure and diabetes. Normal levels are below 150 mg/dL, borderline high levels are between 150 and 199 mg/dL, and high levels of triglycerides are values of 200 mg/dL and above.
Baseline, Months 1, 3, 6, and 12
Change in Systolic Blood Pressure
Time Frame: Baseline, Day 7, Months 1, 3, 6, and 12
Blood pressure is the pressure of circulating blood on the walls of blood vessels, and it is measured in mm Hg. Systolic blood pressure values of less than 120 mm Hg are considered within the normal range.
Baseline, Day 7, Months 1, 3, 6, and 12
Change in Diastolic Blood Pressure
Time Frame: Baseline, Day 7, Months 1, 3, 6, and 12
Blood pressure is the pressure of circulating blood on the walls of blood vessels, and it is measured in mm Hg. Diastolic blood pressure numbers of less than 80 mm Hg are considered within the normal range.
Baseline, Day 7, Months 1, 3, 6, and 12
Change in Orthostatic Blood Pressure
Time Frame: Baseline, Day 7, Months 1, 3, 6, and 12
Blood pressure is obtained while the participant is seated or supine, then the measurement is repeated with the participant standing. Orthostatic hypotension is indicated if systolic blood pressure decreases by 20 mmm Hg or if diastolic blood pressure decreases by 10 mm Hg with the standing measurement.
Baseline, Day 7, Months 1, 3, 6, and 12
Change in Serum Catecholamine Measurements
Time Frame: Baseline, Months 1, 3, 6, and 12
Serum catecholamine measurements assess the amount of dopamine, norepinephrine, and epinephrine in blood. Increased catecholamines are found during times of emotional or physical stress.
Baseline, Months 1, 3, 6, and 12
Change in Glucose Tolerance
Time Frame: Baseline, Months 1, 3, 6, and 12
Glucose tolerance will be measured by oral glucose tolerance tests. A normal glucose level is below 140 mg/dL.
Baseline, Months 1, 3, 6, and 12
Change in Fasting Insulin Levels
Time Frame: Baseline, Day 7, Months 1, 3, 6, and 12
The fasting insulin test is used to diagnose insulin resistance. Normal values for fasting insulin are below 25 milli-international units per liter (mIU/L).
Baseline, Day 7, Months 1, 3, 6, and 12
Change in Fasting C-peptide Levels
Time Frame: Baseline, Day 7, Months 1, 3, 6, and 12
C-peptide levels are used in diagnosing diabetes. Normal values for fasting C-peptide are between 0.5 and 2.0 nanograms per milliliter (ng/mL). Values higher than 2.0 ng/mL can indicate insulin resistance.
Baseline, Day 7, Months 1, 3, 6, and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emory University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Georgia Research Alliance

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: John D Prologo, MD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 19, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 25, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 30, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00000619

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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