Type 2 DiabetesNCT04569721
Percutaneous CT-guided Cryoablation of the Splanchnic Nerves
A study testing CT Guided Splanchnic Cryoablation in people with Type 2 Diabetes, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- CT Guided Splanchnic Cryoablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2021to Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory Johns Creek Hospital
Johns Creek, Georgia, 30097
About this study
Official title: 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.
Read the 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
- Being tested
- CT Guided Splanchnic Cryoablation
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT Guided Splanchnic CryoablationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| CT guided splanchnic cryoablation | Experimental | Obese patients with type 2 diabetes receiving CT guided splanchnic cryoablation. Receives: Device: CT Guided Splanchnic Cryoablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
The number of participant deaths will be used to assess the safety of the study procedure.
Measured: Month 12
Number of Procedure Related Complications
Safety will be assessed by examining procedure related complications, such as bleeding, infection, hypotension, pain, cardiac abnormalities, gastrointestinal abnormalities, or endocrine abnormalities.
Measured: Month 12
Secondary outcomes (17)
Change in Hemoglobin A1c (HbA1c)
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.
Measured: Baseline, Months 1, 3, 6, and 12
Change in Fasting Glucose
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.
Measured: Baseline, Day 7, Months 1, 3, 6, and 12
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
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.
Measured: Baseline, Months 1, 3, 6, and 12
Change in Body Weight
Body weight will be measured in kilograms (kg).
Measured: Baseline, Months 1, 3, 6, and 12
Change in Waist Circumference
Waist circumference will be measured in centimeters (cm).
Measured: Baseline, Months 1, 3, 6, and 12
Change in Waist-to-Hip Ratio
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.
Measured: Baseline, Months 1, 3, 6, and 12
Change in Total Cholesterol
Measuring cholesterol is a diagnostic tool used for estimating risk of cardiac disease. Total cholesterol levels below 200 mg/dL are considered normal.
Measured: Baseline, Months 1, 3, 6, and 12
Change in Low-Density Lipoprotein (LDL)
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.
Measured: Baseline, Months 1, 3, 6, and 12
Change in High-Density Lipoproteins (HDL)
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.
Measured: Baseline, Months 1, 3, 6, and 12
Change in Triglyceride Levels
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.
Measured: Baseline, Months 1, 3, 6, and 12
Change in Systolic Blood Pressure
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.
Measured: Baseline, Day 7, Months 1, 3, 6, and 12
Change in Diastolic Blood Pressure
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.
Measured: Baseline, Day 7, Months 1, 3, 6, and 12
Change in Orthostatic Blood Pressure
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.
Measured: Baseline, Day 7, Months 1, 3, 6, and 12
Change in Serum Catecholamine Measurements
Serum catecholamine measurements assess the amount of dopamine, norepinephrine, and epinephrine in blood. Increased catecholamines are found during times of emotional or physical stress.
Measured: Baseline, Months 1, 3, 6, and 12
Change in Glucose Tolerance
Glucose tolerance will be measured by oral glucose tolerance tests. A normal glucose level is below 140 mg/dL.
Measured: Baseline, Months 1, 3, 6, and 12
Change in Fasting Insulin Levels
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).
Measured: Baseline, Day 7, Months 1, 3, 6, and 12
Change in Fasting C-peptide Levels
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.
Measured: Baseline, Day 7, Months 1, 3, 6, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start19 Feb 2021
- Primary completionFeb 2022 (estimated)
- Study completionFeb 2022 (estimated)
Why it stopped: There was only one subject consented and it was a screen failure. No participants enrolled and study is being closed due to lack of enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Georgia Research Alliance
- Responsible party
- Principal investigator, John Prologo, Emory University
- Investigators
- John D Prologo, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04569721
- Sponsor's protocol ID
- STUDY00000619
- Status last verified
- Jul 2021
- First submitted
- 25 Sep 2020
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous CT-guided Cryoablation of the Splanchnic Nerves for the Management of Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04569721
- Acronym / sponsor ID
- STUDY00000619
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: There was only one subject consented and it was a screen failure. No participants enrolled and study is being closed due to lack of enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Georgia Research Alliance
- Study start
- 19 Feb 2021 (actual)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 30 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT guided splanchnic cryoablation | Experimental | Device: CT Guided Splanchnic CryoablationObese patients with type 2 diabetes receiving CT guided splanchnic cryoablation. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT Guided Splanchnic CryoablationThe 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. | Device | CT guided splanchnic cryoablation |
Primary outcome
Mortality
Time frame: Month 12
The number of participant deaths will be used to assess the safety of the study procedure.
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.
17 secondary outcomes
Change in Hemoglobin A1c (HbA1c)
Time frame: Baseline, Months 1, 3, 6, and 12
Change in Fasting Glucose
Time frame: 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
Change in Body Weight
Time frame: Baseline, Months 1, 3, 6, and 12
Change in Waist Circumference
Time frame: Baseline, Months 1, 3, 6, and 12
Change in Waist-to-Hip Ratio
Time frame: Baseline, Months 1, 3, 6, and 12
Change in Total Cholesterol
Time frame: Baseline, Months 1, 3, 6, and 12
Change in Low-Density Lipoprotein (LDL)
Time frame: Baseline, Months 1, 3, 6, and 12
Change in High-Density Lipoproteins (HDL)
Time frame: Baseline, Months 1, 3, 6, and 12
Change in Triglyceride Levels
Time frame: Baseline, Months 1, 3, 6, and 12
Change in Systolic Blood Pressure
Time frame: 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
Change in Orthostatic Blood Pressure
Time frame: Baseline, Day 7, Months 1, 3, 6, and 12
Change in Serum Catecholamine Measurements
Time frame: Baseline, Months 1, 3, 6, and 12
Change in Glucose Tolerance
Time frame: Baseline, Months 1, 3, 6, and 12
Change in Fasting Insulin Levels
Time frame: 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John D Prologo, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT Guided Splanchnic Cryoablation in people with Type 2 Diabetes, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: Month 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.