Diabetes Type 2NCT04276051
Cryovagotomy Diabetes Trial
A study testing Cryoablation of the Vagus Nerve and Lifestyle Intervention in people with Diabetes Type 2 and Diabetes Mellitus, run by Emory University at 5 sites in United States.
Trial summary
The pilot study will assess the feasibility and efficacy of cryoablation procedure to freeze the vagus nerve in obese patients with type 2 diabetes. Aim 1 will focus on changes in glycemic control. Aim 2 will evaluate differences in body weight and anthropometric measurements. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Diabetes Type 2, Diabetes Mellitus, Obesity
- What is being tested?
- Cryoablation of the Vagus Nerve and Lifestyle Intervention
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 5 sitesUnited States
- Study dates
- 23 Oct 2020to 8 Feb 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Males and females between the ages of 22-65
- Diagnosis of type 2 diabetes mellitus (T2DM) for <10 years
- HbA1c between ≥7.5% and ≤10.5%
- Treatment with non-insulin antidiabetic medications with stable doses for at least 3 months, with failed prior attempts at dietary interventions to optimize diabetes control
- BMI 30-40 kg/m^2
- Willing to comply with study requirements
- Documented negative pregnancy test in women of child bearing potential and use of an effective birth control method
- Average score of ≥3 on questions 4, 8, 9, 13, and 14 from the Three Factor Eating Questionnaire
Who cannot join
- Diagnosis of type 1 diabetes or history of diabetic ketoacidosis
- Use of insulin therapy
- Significant kidney disease (eGFR < 60 ml/min/1.73m^2)
- Current drug or alcohol addiction
- Thyroid disease unless underlying diagnosis is primary hypothyroidism on stable medications for >3 months with thyroid stimulating hormone (TSH) in reference range at time of screening visit
- Systemic steroid use within 30 days prior to randomization
Show all 21Show fewer
- Use of prescription or over the counter weight loss medications within 6 months prior to randomization
- Weight gain/loss >5% over the past 6 months
- Previous GI surgery or abnormal GI anatomy which may limit technical feasibility of the procedure
- Recent diagnosis of cardiovascular disease requiring percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) within the past 6 months
- Abnormal pathologies or conditions of the GI tract, including peptic ulcers, hiatal hernia, active gallbladder disease, pancreatitis, cirrhosis, inflammatory bowel disease, upper GI bleed within 6 months of 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
- 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 blood pressure instability (systolic BP ≤100 or ≥160 mmHg)
- History of autonomic dysfunction, including amyloidosis, Parkinson's disease, autoimmune disease, spinal cord injury
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Emory University Hospital
Atlanta, Georgia, 30322
Grady Health System
Atlanta, Georgia, 30322
The Emory Clinic
Atlanta, Georgia, 30322
Emory Johns Creek Hospital
Johns Creek, Georgia, 30097
About this study
Official title: Effects of Vagus Nerve Cryoablation on Glycemic Control and Weight Loss in Obese Patients With Type 2 Diabetes
The pilot study will assess the feasibility and efficacy of cryoablation procedure to freeze the vagus nerve in obese patients with type 2 diabetes. Aim 1 will focus on changes in glycemic control. Aim 2 will evaluate differences in body weight and anthropometric measurements. This study will provide much needed data for a novel therapeutic intervention to manage obese patients with type 2 diabetes.
Read the detailed description
Obesity is a growing epidemic, currently affecting over 1/3 of the adult US population and is a well-established risk factor for the development of diabetes and cardiovascular disease. Given that the majority of patients with type 2 diabetes (T2D) are obese, weight loss is the cornerstone of treatment, and has been shown to decrease risk of long term complications, lead to improvements in A1c and lipid levels, as well as decreased need for medications and improvements in quality of life. Unfortunately, lifestyle intervention is often ineffective at achieving long-term sustainable, clinically significant weight loss. Bariatric surgery is a successful intervention, leading to 20-30% weight loss with remission of diabetes in 30-65% of patients 1-5 years post surgery. However, this invasive procedure is associated with high rates of short- and long-term complications, including need for reoperations, vitamin/mineral deficiencies, anemia, and osteoporosis. It is clear that the current management options for obese patients, including lifestyle changes, medications and surgery, are suboptimal and innovative strategies are necessary to optimize diabetes control and weight management.
Energy balance and glycemic control are mediated largely by the gut-brain axis, specifically the vagus nerve. The vagus nerve can stimulate or inhibit food intake depending on nutritional status. Vagal nerve signaling is disrupted in the setting of obesity and thought to contribute to overeating behaviors. Vagus nerve blockade has the potential to be a highly efficacious, minimally invasive intervention to address current obesity treatment limitations. Clinical studies evaluating the efficacy of an implantable electric vagus nerve blockade device found that subjects lost on average 8.8% of total body weight at 1 year; patients with T2D experienced improved glycemic control, with an average A1c improvement of 1.0% at 12 months. Unfortunately, nearly 40% of subjects experienced side effects related to the device. A recent pilot study from the researchers of this study reported weight loss efficacy of a minimally invasive computerized tomography (CT) guided cryoablation of the vagus nerve in obese, non-diabetic subjects. Patients lost 5.6% of total body weight and 22.7% excess body weight at 6 months with no significant side effects. The purpose of this current study is to evaluate the feasibility and efficacy of this procedure through a randomized control trial in obese patients with T2D. The researchers hypothesize that those patients undergoing the cryoablation procedure will experience improvement in glycemic control and enhanced weight loss at 6 months follow-up compared to the control group.
Participants will be randomized to receive either CT guided cryoablation of the vagus nerve plus lifestyle intervention or lifestyle intervention alone. The lifestyle intervention lasts for 26 weeks and participants will be followed for 12 months in total.
- Conditions
- Diabetes Type 2, Diabetes Mellitus, Obesity
- Being tested
- Cryoablation of the Vagus Nerve, Lifestyle Intervention
- Keywords
- Obesity, Diabetes, Neurophysiology, Cryovagotomy, Glycemic control
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryoablation of the Vagus NerveDevice
Also called Visual ICE Cryoablation System
The Visual ICE Cryoablation System is a mobile console system intended for cryoablative tissue destruction using a minimally invasive procedure. The Visual-ICE System uses high-pressure argon gas that circulates through closed-tip cryoablation needles to induce tissue freezing. Active tissue thawing is achieved by circulating helium gas through the needles or, alternatively, by the use of Galil Medical i-Thaw technology. The procedure will be done under CT guidance and involves a 4-5 mm scalpel incision followed by percutaneous probe placement about the posterior gastroesophageal junction (the location of the posterior vagal trunk). The probe will create a zone of decreased temperature (-20 to -40 degrees Celsius) involving the posterior vagal nerve fibers/plexus. The cryoablation process will include a 3-minute freeze, followed by a 1-minute thaw, and a second 3-minute freeze and 1 minute thaw.
Lifestyle InterventionBehavioural
The lifestyle intervention structure will include three face-to-face counseling sessions at baseline, 3 and 6 months. Dietary counseling to follow a low carbohydrate diet will be provided by a registered dietitian. Focus will be on increasing fruits and vegetables and decreasing refined sugars and processed foods. It will also include motivational interviewing, goal setting and nutrition education. In addition, subjects will be encouraged by exercise physiologist to slowly increase physical activity to at least 150 minutes weekly. There will be weekly phone calls or texts (participants' choice) providing a total of 26 points of contact recommended by the United States Preventive Services Task Force.
| Study group | Role | What they receive |
|---|---|---|
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Experimental | Participants randomized to receive cryoablation of the vagus nerve as well as standardized dietary and exercise counseling from a registered dietitian and exercise physiologist. Receives: Device: Cryoablation of the Vagus Nerve; Behavioral: Lifestyle Intervention |
| Lifestyle Intervention Only | Active comparator | Participants randomized to receive standardized dietary and exercise counseling from a registered dietitian and exercise physiologist. Receives: Behavioral: Lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
The hemoglobin A1c test result reflects average blood sugar level for the past two to three months. Specifically, the A1c test measures what percentage of hemoglobin is coated with sugar (glycated). The higher A1c level, the poorer blood sugar control and the higher risk of diabetes complications.
Measured: Baseline, Month 3, Month 6, Month 12
Insulin Resistance Score Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Insulin resistance score HOMA-IR is computed with the formula: fasting plasma glucose (mmol/l) times fasting serum insulin (mU/l) divided by 22.5. Low HOMA-IR values indicate high insulin sensitivity, whereas high HOMA-IR values indicate low insulin sensitivity (insulin resistance).
Measured: Baseline, Month 3, Month 6, Month 12
Number of Deaths Among Recipients of the Cryoablation
Mortality among recipients of the cryoablation was documented.
Measured: Up to Month 12
Number of Adverse Events Related to the Cryoablation
The count of procedure related complications, such as bleeding, infection, pneumothorax, hemothorax, pulmonary injury, complications of sedation, pain requiring hospital admission or treatment, dysphagia, gastroparesis, nausea and vomiting, and gastrointestinal ulceration was documented for the duration of the study.
Measured: Up to Month 12
Secondary outcomes (18)
Body Mass Index (BMI)
Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters.
Measured: Baseline, Month 3, Month 6
Waist Circumference
Waist circumference is a measurement taken around the abdomen at the level of the umbilicus (belly button). Waist circumference is measured in centimeters.
Measured: Baseline, Month 3, Month 6
Waist-to-hip Ratio
A waist-to-hip ratio of greater than 1.0 indicates a higher risk of developing heart disease. For women, a healthy waist-to-hip ratio is less than 0.85 while under 0.9 is a healthy ratio for men.
Measured: Baseline, Month 3, Month 6
Total Cholesterol
A healthy level of total cholesterol is 125 - 200 mg/dL.
Measured: Baseline, Month 6
Low-Density Lipoprotein (LDL)
A healthy level of LDL is less than 100 mg/dL.
Measured: Baseline, Month 6
Triglycerides
A healthy level of triglycerides is less than 150 mg/dL.
Measured: Baseline, Month 6
Systolic Blood Pressure
A normal systolic blood pressure level is less than 120 millimeters of mercury (mmHg).
Measured: Baseline, Month 3, Month 6
Diastolic Blood Pressure
A normal diastolic blood pressure level is less than 80 mmHg.
Measured: Baseline, Month 3, Month 6
Daily Caloric Intake
Daily caloric intake is measured by 3-day food recall. Mean daily caloric intake is assessed as kilocalories (kcal) consumed per day.
Measured: Baseline, Month 3, Month 6
Change in Anti-hyperglycemic Medication Regimen
Anti-hyperglycemic medications will be adjusted at visits under the direction of the endocrinologist, or as needed for clinically significant hypo- or hyperglycemic events. Changes in baseline medication regimen will be examined to determine if medication needs decrease or increase during the study.
Measured: Month 3, Month 6
Appetite Visual Analog Scale Score for Hunger
The Appetite Visual Analog Scale includes 8 items which are scored on 100-mm visual analogue scales. The item for hunger asks participants how hungry they feel, where 0 = not at all and 100 = never been more hungry.
Measured: Baseline, Week 1, Month 1, Month 3, Month 6
Appetite Visual Analog Scale Score for Satisfaction
The Appetite Visual Analog Scale includes 8 items which are scored on 100-mm visual analogue scales. The item for satisfaction asks participants how satisfied they feel, where 0 = completely empty and 100 = cannot eat another bite.
Measured: Baseline, Week 1, Month 1, Month 3, Month 6
Appetite Visual Analog Scale Score for Fullness
The Appetite Visual Analog Scale includes 8 items which are scored on 100-mm visual analogue scales. The item for fullness asks participants how full they feel, where 0 = not full at all and 100 = totally full.
Measured: Baseline, Week 1, Month 1, Month 3, Month 6
Appetite Visual Analog Scale Score for Eating Quantity
The Appetite Visual Analog Scale includes 8 items which are scored on 100-mm visual analogue scales. The item for eating quantity asks participants how much they think they can eat, where 0 = nothing at all and 100 = a lot.
Measured: Baseline, Week 1, Month 1, Month 3, Month 6
Appetite Visual Analog Scale Score for Desire for Certain Foods
The Appetite Visual Analog Scale includes 8 items which are scored on 100-mm visual analogue scales. Four items of the questionnaire ask participants if they would like to eat something sweet, salty, savory, and fatty. Each item is scored as 0 = yes, very much and 100 = no, not at all.
Measured: Baseline, Week 1, Month 1, Month 3, Month 6
International Physical Activity Questionnaire (IPAQ) Score
The IPAQ assesses physical activity during the past 7 days with 27 items. Based on the type, duration, and frequency of activity, respondents are categorized as having low activity, moderate activity, or high activity.
Measured: Baseline, Month 3, Month 6
Fasting Glucose Level
A normal fasting blood sugar level is 99 mg/dL or lower, glucose levels of 100 - 125 mg/dL indicates prediabetes, and levels of 126 mg/dL and higher indicates diabetes.
Measured: Baseline, Month 3, Month 6
Fasting Insulin Level
A normal fasting insulin level for the Emory Healthcare Laboratory is 1.9 to 23.0 milli-international units per liter (mIU/L). High levels of fasting insulin are associated with obesity and early stage type 2 diabetes (T2D). Type 1 diabetes and advanced T2D are associated with low levels of insulin.
Measured: Baseline, Month 3, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start23 Oct 2020
- Primary completion8 Feb 2022
- Study completion8 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Type 2Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandra Migdal, Emory University
- Investigators
- Alexandra Migdal, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04276051
- Sponsor's protocol ID
- IRB00109624
- Status last verified
- Feb 2023
- First submitted
- 17 Feb 2020
- Last updated
- 8 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices) will be available for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vagus Nerve Cryoablation on Glycemic Control and Weight Loss in Obese Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04276051
- Acronym / sponsor ID
- IRB00109624
- Conditions
- Diabetes Type 2, Diabetes Mellitus, Obesity
- Keywords
- Obesity, Diabetes, Neurophysiology, Cryovagotomy, Glycemic control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 23 Oct 2020 (actual)
- Primary completion
- 8 Feb 2022 (actual)
- Study completion
- 8 Feb 2022 (actual)
- First posted
- 19 Feb 2020 (actual)
- Results
- Posted 8 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The pilot study will assess the feasibility and efficacy of cryoablation procedure to freeze the vagus nerve in obese patients with type 2 diabetes. Aim 1 will focus on changes in glycemic control. Aim 2 will evaluate differences in body weight and anthropometric measurements. This study will provide much needed data for a novel therapeutic intervention to manage obese patients with type 2 diabetes.
Detailed description
Obesity is a growing epidemic, currently affecting over 1/3 of the adult US population and is a well-established risk factor for the development of diabetes and cardiovascular disease. Given that the majority of patients with type 2 diabetes (T2D) are obese, weight loss is the cornerstone of treatment, and has been shown to decrease risk of long term complications, lead to improvements in A1c and lipid levels, as well as decreased need for medications and improvements in quality of life. Unfortunately, lifestyle intervention is often ineffective at achieving long-term sustainable, clinically significant weight loss. Bariatric surgery is a successful intervention, leading to 20-30% weight loss with remission of diabetes in 30-65% of patients 1-5 years post surgery. However, this invasive procedure is associated with high rates of short- and long-term complications, including need for reoperations, vitamin/mineral deficiencies, anemia, and osteoporosis. It is clear that the current management options for obese patients, including lifestyle changes, medications and surgery, are suboptimal and innovative strategies are necessary to optimize diabetes control and weight management.
Energy balance and glycemic control are mediated largely by the gut-brain axis, specifically the vagus nerve. The vagus nerve can stimulate or inhibit food intake depending on nutritional status. Vagal nerve signaling is disrupted in the setting of obesity and thought to contribute to overeating behaviors. Vagus nerve blockade has the potential to be a highly efficacious, minimally invasive intervention to address current obesity treatment limitations. Clinical studies evaluating the efficacy of an implantable electric vagus nerve blockade device found that subjects lost on average 8.8% of total body weight at 1 year; patients with T2D experienced improved glycemic control, with an average A1c improvement of 1.0% at 12 months. Unfortunately, nearly 40% of subjects experienced side effects related to the device. A recent pilot study from the researchers of this study reported weight loss efficacy of a minimally invasive computerized tomography (CT) guided cryoablation of the vagus nerve in obese, non-diabetic subjects. Patients lost 5.6% of total body weight and 22.7% excess body weight at 6 months with no significant side effects. The purpose of this current study is to evaluate the feasibility and efficacy of this procedure through a randomized control trial in obese patients with T2D. The researchers hypothesize that those patients undergoing the cryoablation procedure will experience improvement in glycemic control and enhanced weight loss at 6 months follow-up compared to the control group.
Participants will be randomized to receive either CT guided cryoablation of the vagus nerve plus lifestyle intervention or lifestyle intervention alone. The lifestyle intervention lasts for 26 weeks and participants will be followed for 12 months in total.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Experimental | Device: Cryoablation of the Vagus Nerve, Behavioral: Lifestyle InterventionParticipants randomized to receive cryoablation of the vagus nerve as well as standardized dietary and exercise counseling from a registered dietitian and exercise physiologist. |
| Lifestyle Intervention Only | Active comparator | Behavioral: Lifestyle InterventionParticipants randomized to receive standardized dietary and exercise counseling from a registered dietitian and exercise physiologist. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males and females between the ages of 22-65
- Diagnosis of type 2 diabetes mellitus (T2DM) for <10 years
- HbA1c between ≥7.5% and ≤10.5%
- Treatment with non-insulin antidiabetic medications with stable doses for at least 3 months, with failed prior attempts at dietary interventions to optimize diabetes control
- BMI 30-40 kg/m^2
Key exclusion criteria (21 listed)
- Diagnosis of type 1 diabetes or history of diabetic ketoacidosis
- Use of insulin therapy
- Significant kidney disease (eGFR < 60 ml/min/1.73m^2)
- Current drug or alcohol addiction
- Thyroid disease unless underlying diagnosis is primary hypothyroidism on stable medications for >3 months with thyroid stimulating hormone (TSH) in reference range at time of screening visit
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 |
|---|---|---|
| Cryoablation of the Vagus NerveAlso: Visual ICE Cryoablation SystemThe Visual ICE Cryoablation System is a mobile console system intended for cryoablative tissue destruction using a minimally invasive procedure. The Visual-ICE System uses high-pressure argon gas that circulates through closed-tip cryoablation needles to induce tissue freezing. Active tissue thawing is achieved by circulating helium gas through the needles or, alternatively, by the use of Galil Medical i-Thaw technology. The procedure will be done under CT guidance and involves a 4-5 mm scalpel incision followed by percutaneous probe placement about the posterior gastroesophageal junction (the location of the posterior vagal trunk). The probe will create a zone of decreased temperature (-20 to -40 degrees Celsius) involving the posterior vagal nerve fibers/plexus. The cryoablation process will include a 3-minute freeze, followed by a 1-minute thaw, and a second 3-minute freeze and 1 minute thaw. | Device | Cryoablation of the Vagus Nerve Plus Lifestyle Intervention |
| Lifestyle InterventionThe lifestyle intervention structure will include three face-to-face counseling sessions at baseline, 3 and 6 months. Dietary counseling to follow a low carbohydrate diet will be provided by a registered dietitian. Focus will be on increasing fruits and vegetables and decreasing refined sugars and processed foods. It will also include motivational interviewing, goal setting and nutrition education. In addition, subjects will be encouraged by exercise physiologist to slowly increase physical activity to at least 150 minutes weekly. There will be weekly phone calls or texts (participants' choice) providing a total of 26 points of contact recommended by the United States Preventive Services Task Force. | Behavioural | Cryoablation of the Vagus Nerve Plus Lifestyle Intervention, Lifestyle Intervention Only |
Primary outcome
Hemoglobin A1c
Time frame: Baseline, Month 3, Month 6, Month 12
The hemoglobin A1c test result reflects average blood sugar level for the past two to three months. Specifically, the A1c test measures what percentage of hemoglobin is coated with sugar (glycated). The higher A1c level, the poorer blood sugar control and the higher risk of diabetes complications.
Insulin Resistance Score Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: Baseline, Month 3, Month 6, Month 12
Insulin resistance score HOMA-IR is computed with the formula: fasting plasma glucose (mmol/l) times fasting serum insulin (mU/l) divided by 22.5. Low HOMA-IR values indicate high insulin sensitivity, whereas high HOMA-IR values indicate low insulin sensitivity (insulin resistance).
Number of Deaths Among Recipients of the Cryoablation
Time frame: Up to Month 12
Mortality among recipients of the cryoablation was documented.
Number of Adverse Events Related to the Cryoablation
Time frame: Up to Month 12
The count of procedure related complications, such as bleeding, infection, pneumothorax, hemothorax, pulmonary injury, complications of sedation, pain requiring hospital admission or treatment, dysphagia, gastroparesis, nausea and vomiting, and gastrointestinal ulceration was documented for the duration of the study.
18 secondary outcomes
Body Mass Index (BMI)
Time frame: Baseline, Month 3, Month 6
Waist Circumference
Time frame: Baseline, Month 3, Month 6
Waist-to-hip Ratio
Time frame: Baseline, Month 3, Month 6
Total Cholesterol
Time frame: Baseline, Month 6
Low-Density Lipoprotein (LDL)
Time frame: Baseline, Month 6
Triglycerides
Time frame: Baseline, Month 6
Systolic Blood Pressure
Time frame: Baseline, Month 3, Month 6
Diastolic Blood Pressure
Time frame: Baseline, Month 3, Month 6
Daily Caloric Intake
Time frame: Baseline, Month 3, Month 6
Change in Anti-hyperglycemic Medication Regimen
Time frame: Month 3, Month 6
Appetite Visual Analog Scale Score for Hunger
Time frame: Baseline, Week 1, Month 1, Month 3, Month 6
Appetite Visual Analog Scale Score for Satisfaction
Time frame: Baseline, Week 1, Month 1, Month 3, Month 6
Appetite Visual Analog Scale Score for Fullness
Time frame: Baseline, Week 1, Month 1, Month 3, Month 6
Appetite Visual Analog Scale Score for Eating Quantity
Time frame: Baseline, Week 1, Month 1, Month 3, Month 6
Appetite Visual Analog Scale Score for Desire for Certain Foods
Time frame: Baseline, Week 1, Month 1, Month 3, Month 6
International Physical Activity Questionnaire (IPAQ) Score
Time frame: Baseline, Month 3, Month 6
Fasting Glucose Level
Time frame: Baseline, Month 3, Month 6
Fasting Insulin Level
Time frame: Baseline, Month 3, Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices) will be available for sharing.
Related trials for Diabetes Type 2
Not yet recruiting
Efficacy, Safety, and Treatment Satisfaction of Once-Weekly Tirzepatide in Obese Type 2 Diabetic Patients
Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Active, not recruiting
Helping Adults With Type 2 Diabetes Use Their Health Data for Healthy Diabetes Self-Management
Type 2 Diabetes Mellitus (T2DM)
Not yet recruiting
Care COMPASS Study
Diabetes Mellitus ( Type 1 and Type 2), Hypertension
Enrolling by invitationObservational study
Personalizing A1c Using Hematologic Indices and CGM for Accurate Diabetes Diagnosis
Type 2 Diabetes
RecruitingObservational study
Investigating the Link Between Advanced Glycation End Products (AGEs) and Muscle Wasting in Sarcobesity
Sarcopenia, Obesity
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.
Alexandra Migdal, MD principal investigator
Emory University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoablation of the Vagus Nerve and Lifestyle Intervention in people with Diabetes Type 2 and Diabetes Mellitus, run by Emory University at 5 sites 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 8 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: finished, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Yes. Results are posted in the registry (first posted 8 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hemoglobin A1c (time frame: Baseline, Month 3, Month 6, Month 12). The study lists 4 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 8 Mar 2023.