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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Lifestyle Intervention Only | Active Comparator | Participants randomized to receive standardized dietary and exercise counseling from a registered dietitian and exercise physiologist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryoablation of the Vagus Nerve | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | Baseline, Month 3, Month 6, Month 12 |
| Number of Deaths Among Recipients of the Cryoablation | Mortality among recipients of the cryoablation was documented. | 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. | Up to Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index (BMI) | Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexandra Migdal, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | United States | ||
| Emory University Hospital |
Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices) will be available for sharing.
Data will be available for sharing beginning 6 months after publication of findings from this study and ending 5 years after publication.
Data will be available for sharing with researchers who provide a methodologically sound proposal, in order to achieve the aims in the approved proposal. Requests to access the data should be directed to amigdal@emory.edu. To gain access, data requestors will need to sign a data access agreement
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Participants were recruited from Emory University Hospital and Clinics, and Grady Health System in Atlanta, Georgia, USA. Participant enrollment began October 23, 2020 and all follow-up assessments were completed by February 8, 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Participants randomized to receive cryoablation of the vagus nerve as well as standardized dietary and exercise counseling from a registered dietitian and exercise physiologist. |
| FG001 | Lifestyle Intervention Only | Participants randomized to receive standardized dietary and exercise counseling from a registered dietitian and exercise physiologist. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Participants randomized to receive cryoablation of the vagus nerve as well as standardized dietary and exercise counseling from a registered dietitian and exercise physiologist. |
| BG001 | Lifestyle Intervention Only |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | This analysis includes participants who attended the indicated study visit. One participant from the cryoablation plus lifestyle intervention group withdrew after the Month 6 visit. All three participants in the lifestyle intervention group were withdrawn or lost to follow up prior to the Month 3 visit. | Posted | Mean | Standard Deviation | percent of glycated hemoglobin | Baseline, Month 3, Month 6, Month 12 |
|
Information on adverse events was collected beginning at the time individuals gave consent to participate in the study and continued through the 12 Month study visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cryoablation of the Vagus Nerve Plus Lifestyle Intervention | Participants randomized to receive cryoablation of the vagus nerve as well as standardized dietary and exercise counseling from a registered dietitian and exercise physiologist. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Right upper quadrant abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexandra Migdal, MD | Emory University | 404-778-3280 | alexandra.love.migdal@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 22, 2021 | Feb 6, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Lifestyle Intervention | Behavioral | 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. |
|
| 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. | Baseline, Month 3, Month 6 |
| Total Cholesterol | A healthy level of total cholesterol is 125 - 200 mg/dL. | Baseline, Month 6 |
| Low-Density Lipoprotein (LDL) | A healthy level of LDL is less than 100 mg/dL. | Baseline, Month 6 |
| Triglycerides | A healthy level of triglycerides is less than 150 mg/dL. | Baseline, Month 6 |
| Systolic Blood Pressure | A normal systolic blood pressure level is less than 120 millimeters of mercury (mmHg). | Baseline, Month 3, Month 6 |
| Diastolic Blood Pressure | A normal diastolic blood pressure level is less than 80 mmHg. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline, Month 3, Month 6 |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Grady Health System | Atlanta | Georgia | 30322 | United States |
| The Emory Clinic | Atlanta | Georgia | 30322 | United States |
| Emory Johns Creek Hospital | Johns Creek | Georgia | 30097 | United States |
| Withdrawal by Subject |
|
Participants randomized to receive standardized dietary and exercise counseling from a registered dietitian and exercise physiologist. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Lifestyle Intervention Only | Participants randomized to receive standardized dietary and exercise counseling from a registered dietitian and exercise physiologist. |
|
|
| Primary | 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). | This analysis includes participants who attended the indicated study visit. One participant from the cryoablation plus lifestyle intervention group withdrew after the Month 6 visit. All three participants in the lifestyle intervention group were withdrawn or lost to follow up prior to the Month 3 visit. | Posted | Mean | Standard Deviation | (mmol/l X mU/l) / 22.5 | Baseline, Month 3, Month 6, Month 12 |
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| Primary | Number of Deaths Among Recipients of the Cryoablation | Mortality among recipients of the cryoablation was documented. | Posted | Count of Participants | Participants | Up to Month 12 |
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| Primary | 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. | Posted | Number | related complications | Up to Month 12 |
|
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|
| Secondary | Body Mass Index (BMI) | Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters. | One participant from the cryoablation plus lifestyle intervention group attended the Month 6 study visit but did not complete all study activities for that visit. All three participants in the lifestyle intervention group were withdrawn or lost to follow up prior to the Month 3 visit. | Posted | Mean | Standard Deviation | kg/m^2 | Baseline, Month 3, Month 6 |
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| Secondary | 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. | One participant from the cryoablation plus lifestyle intervention group attended the Month 6 study visit but did not complete all study activities for that visit. All three participants in the lifestyle intervention group were withdrawn or lost to follow up prior to the Month 3 visit. | Posted | Mean | Standard Deviation | cm | Baseline, Month 3, Month 6 |
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| Secondary | 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. | One participant from the cryoablation plus lifestyle intervention group attended the Month 6 study visit but did not complete all study activities for that visit. All three participants in the lifestyle intervention group were withdrawn or lost to follow up prior to the Month 3 visit. | Posted | Mean | Standard Deviation | waist cm/hip cm | Baseline, Month 3, Month 6 |
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| Secondary | Total Cholesterol | A healthy level of total cholesterol is 125 - 200 mg/dL. | This analysis includes participants who attended the indicated study visit. All three participants in the lifestyle intervention group were withdrawn or lost to follow up prior to the Month 3 visit. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Month 6 |
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| Secondary | Low-Density Lipoprotein (LDL) | A healthy level of LDL is less than 100 mg/dL. | This analysis includes participants who attended the indicated study visit. All three participants in the lifestyle intervention group were withdrawn or lost to follow up prior to the Month 3 visit. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Month 6 |
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| Secondary | Triglycerides | A healthy level of triglycerides is less than 150 mg/dL. | This analysis includes participants who attended the indicated study visit. All three participants in the lifestyle intervention group were withdrawn or lost to follow up prior to the Month 3 visit. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Month 6 |
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| Secondary | Systolic Blood Pressure | A normal systolic blood pressure level is less than 120 millimeters of mercury (mmHg). | One participant from the cryoablation plus lifestyle intervention group attended the Month 6 study visit but did not complete all study activities for that visit. All three participants in the lifestyle intervention group were withdrawn or lost to follow up prior to the Month 3 visit. | Posted | Mean | Standard Deviation | mmHg | Baseline, Month 3, Month 6 |
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| Secondary | Diastolic Blood Pressure | A normal diastolic blood pressure level is less than 80 mmHg. | One participant from the cryoablation plus lifestyle intervention group attended the Month 6 study visit but did not complete all study activities for that visit. All three participants in the lifestyle intervention group were withdrawn or lost to follow up prior to the Month 3 visit. | Posted | Mean | Standard Deviation | mmHg | Baseline, Month 3, Month 6 |
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| Secondary | 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. | The 3-day food recall diary was not completed by any study participants. | Posted | Baseline, Month 3, Month 6 |
|
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| Secondary | 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. | This analysis includes participants who attended the indicated study visit. All three participants in the lifestyle intervention group were withdrawn or lost to follow up prior to the Month 3 visit. | Posted | Count of Participants | Participants | Month 3, Month 6 |
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| Secondary | 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. | One participant from the cryoablation plus lifestyle intervention group attended the Month 6 study visit but did not complete all study activities for that visit. All three participants in the lifestyle intervention group were withdrawn or lost to follow up prior to the Month 3 visit. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 1, Month 1, Month 3, Month 6 |
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| Secondary | 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. | One participant from the cryoablation plus lifestyle intervention group attended the Month 6 study visit but did not complete all study activities for that visit. All three participants in the lifestyle intervention group were withdrawn or lost to follow up prior to the Month 3 visit. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 1, Month 1, Month 3, Month 6 |
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| Secondary | 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. | One participant from the cryoablation plus lifestyle intervention group attended the Month 6 study visit but did not complete all study activities for that visit. All three participants in the lifestyle intervention group were withdrawn or lost to follow up prior to the Month 3 visit. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 1, Month 1, Month 3, Month 6 |
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| Secondary | 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. | One participant from the cryoablation plus lifestyle intervention group attended the Month 6 study visit but did not complete all study activities for that visit. All three participants in the lifestyle intervention group were withdrawn or lost to follow up prior to the Month 3 visit. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 1, Month 1, Month 3, Month 6 |
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| Secondary | 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. | One participant from the cryoablation plus lifestyle intervention group attended the Month 6 study visit but did not complete all study activities for that visit. All three participants in the lifestyle intervention group were withdrawn or lost to follow up prior to the Month 3 visit. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 1, Month 1, Month 3, Month 6 |
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| Secondary | 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. | This analysis includes participants who attended the indicated study visit. All three participants in the lifestyle intervention group were withdrawn or lost to follow up prior to the Month 3 visit. | Posted | Count of Participants | Participants | Baseline, Month 3, Month 6 |
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| Secondary | 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. | This analysis includes participants who attended the indicated study visit. All three participants in the lifestyle intervention group were withdrawn or lost to follow up prior to the Month 3 visit. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Month 3, Month 6 |
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| Secondary | 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. | This analysis includes participants who attended the indicated study visit. All three participants in the lifestyle intervention group were withdrawn or lost to follow up prior to the Month 3 visit. | Posted | Mean | Standard Deviation | mIU/L | Baseline, Month 3, Month 6 |
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| 0 |
| 2 |
| 0 |
| 2 |
| 2 |
| 2 |
| EG001 | Lifestyle Intervention Only | Participants randomized to receive standardized dietary and exercise counseling from a registered dietitian and exercise physiologist. | 0 | 3 | 0 | 3 | 0 | 3 |
| Dizziness | General disorders | Non-systematic Assessment |
|
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| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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