Trial Outcomes & Findings for Cryovagotomy Diabetes Trial (NCT NCT04276051)
NCT ID: NCT04276051
Last Updated: 2023-03-08
Results Overview
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.
COMPLETED
NA
5 participants
Baseline, Month 3, Month 6, Month 12
2023-03-08
Participant Flow
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.
Participant milestones
| Measure |
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.
|
Lifestyle Intervention Only
Participants randomized to receive standardized dietary and exercise counseling from a registered dietitian and exercise physiologist.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
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.
|
Lifestyle Intervention Only
Participants randomized to receive standardized dietary and exercise counseling from a registered dietitian and exercise physiologist.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Cryovagotomy Diabetes Trial
Baseline characteristics by cohort
| Measure |
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
n=2 Participants
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
n=3 Participants
Participants randomized to receive standardized dietary and exercise counseling from a registered dietitian and exercise physiologist.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
53.5 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
54.7 years
STANDARD_DEVIATION 8.37 • n=7 Participants
|
54.2 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 3, Month 6, Month 12Population: 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.
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.
Outcome measures
| Measure |
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
n=2 Participants
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
n=3 Participants
Participants randomized to receive standardized dietary and exercise counseling from a registered dietitian and exercise physiologist.
|
|---|---|---|
|
Hemoglobin A1c
Baseline
|
8.35 percent of glycated hemoglobin
Standard Deviation 0.25
|
8.86 percent of glycated hemoglobin
Standard Deviation 0.40
|
|
Hemoglobin A1c
Month 3
|
8.75 percent of glycated hemoglobin
Standard Deviation 0.05
|
—
|
|
Hemoglobin A1c
Month 6
|
8.40 percent of glycated hemoglobin
Standard Deviation 0.20
|
—
|
|
Hemoglobin A1c
Month 12
|
9.30 percent of glycated hemoglobin
Standard Deviation 0.0
|
—
|
PRIMARY outcome
Timeframe: Baseline, Month 3, Month 6, Month 12Population: 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.
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).
Outcome measures
| Measure |
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
n=2 Participants
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
n=3 Participants
Participants randomized to receive standardized dietary and exercise counseling from a registered dietitian and exercise physiologist.
|
|---|---|---|
|
Insulin Resistance Score Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Baseline
|
7.85 (mmol/l X mU/l) / 22.5
Standard Deviation 1.75
|
4.70 (mmol/l X mU/l) / 22.5
Standard Deviation 2.94
|
|
Insulin Resistance Score Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Month 3
|
7.00 (mmol/l X mU/l) / 22.5
Standard Deviation 1.00
|
—
|
|
Insulin Resistance Score Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Month 6
|
10.70 (mmol/l X mU/l) / 22.5
Standard Deviation 1.60
|
—
|
|
Insulin Resistance Score Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Month 12
|
7.00 (mmol/l X mU/l) / 22.5
Standard Deviation 0.0
|
—
|
PRIMARY outcome
Timeframe: Up to Month 12Mortality among recipients of the cryoablation was documented.
Outcome measures
| Measure |
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
n=2 Participants
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
Participants randomized to receive standardized dietary and exercise counseling from a registered dietitian and exercise physiologist.
|
|---|---|---|
|
Number of Deaths Among Recipients of the Cryoablation
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to Month 12The 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.
Outcome measures
| Measure |
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
n=2 Participants
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
Participants randomized to receive standardized dietary and exercise counseling from a registered dietitian and exercise physiologist.
|
|---|---|---|
|
Number of Adverse Events Related to the Cryoablation
|
0 related complications
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6Population: 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.
Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters.
Outcome measures
| Measure |
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
n=2 Participants
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
n=3 Participants
Participants randomized to receive standardized dietary and exercise counseling from a registered dietitian and exercise physiologist.
|
|---|---|---|
|
Body Mass Index (BMI)
Baseline
|
37.25 kg/m^2
Standard Deviation 1.55
|
33.26 kg/m^2
Standard Deviation 3.71
|
|
Body Mass Index (BMI)
Month 3
|
37.25 kg/m^2
Standard Deviation 0.25
|
—
|
|
Body Mass Index (BMI)
Month 6
|
39.5 kg/m^2
Standard Deviation 0.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6Population: 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.
Waist circumference is a measurement taken around the abdomen at the level of the umbilicus (belly button). Waist circumference is measured in centimeters.
Outcome measures
| Measure |
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
n=2 Participants
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
n=3 Participants
Participants randomized to receive standardized dietary and exercise counseling from a registered dietitian and exercise physiologist.
|
|---|---|---|
|
Waist Circumference
Baseline
|
121.3 cm
Standard Deviation 9.5
|
147.66 cm
Standard Deviation 58.39
|
|
Waist Circumference
Month 3
|
117.5 cm
Standard Deviation 2.5
|
—
|
|
Waist Circumference
Month 6
|
127 cm
Standard Deviation 0.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6Population: 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.
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.
Outcome measures
| Measure |
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
n=2 Participants
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
n=3 Participants
Participants randomized to receive standardized dietary and exercise counseling from a registered dietitian and exercise physiologist.
|
|---|---|---|
|
Waist-to-hip Ratio
Baseline
|
0.97 waist cm/hip cm
Standard Deviation 0.02
|
1.06 waist cm/hip cm
Standard Deviation 0.04
|
|
Waist-to-hip Ratio
Month 3
|
0.95 waist cm/hip cm
Standard Deviation 0.05
|
—
|
|
Waist-to-hip Ratio
Month 6
|
1.0 waist cm/hip cm
Standard Deviation 0.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: 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.
A healthy level of total cholesterol is 125 - 200 mg/dL.
Outcome measures
| Measure |
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
n=2 Participants
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
n=3 Participants
Participants randomized to receive standardized dietary and exercise counseling from a registered dietitian and exercise physiologist.
|
|---|---|---|
|
Total Cholesterol
Baseline
|
198.00 mg/dL
Standard Deviation 39.00
|
194.33 mg/dL
Standard Deviation 39.19
|
|
Total Cholesterol
Month 6
|
179.00 mg/dL
Standard Deviation 42.00
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: 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.
A healthy level of LDL is less than 100 mg/dL.
Outcome measures
| Measure |
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
n=2 Participants
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
n=3 Participants
Participants randomized to receive standardized dietary and exercise counseling from a registered dietitian and exercise physiologist.
|
|---|---|---|
|
Low-Density Lipoprotein (LDL)
Baseline
|
120.5 mg/dL
Standard Deviation 30.5
|
121.33 mg/dL
Standard Deviation 30.61
|
|
Low-Density Lipoprotein (LDL)
Month 6
|
102.0 mg/dL
Standard Deviation 36.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: 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.
A healthy level of triglycerides is less than 150 mg/dL.
Outcome measures
| Measure |
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
n=2 Participants
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
n=3 Participants
Participants randomized to receive standardized dietary and exercise counseling from a registered dietitian and exercise physiologist.
|
|---|---|---|
|
Triglycerides
Baseline
|
110 mg/dL
Standard Deviation 16
|
151 mg/dL
Standard Deviation 82
|
|
Triglycerides
Month 6
|
85 mg/dL
Standard Deviation 9
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6Population: 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.
A normal systolic blood pressure level is less than 120 millimeters of mercury (mmHg).
Outcome measures
| Measure |
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
n=2 Participants
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
n=3 Participants
Participants randomized to receive standardized dietary and exercise counseling from a registered dietitian and exercise physiologist.
|
|---|---|---|
|
Systolic Blood Pressure
Baseline
|
127.00 mmHg
Standard Deviation 14.00
|
139.66 mmHg
Standard Deviation 8.17
|
|
Systolic Blood Pressure
Month 3
|
112.50 mmHg
Standard Deviation 5.50
|
—
|
|
Systolic Blood Pressure
Month 6
|
113.0 mmHg
Standard Deviation 0.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6Population: 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.
A normal diastolic blood pressure level is less than 80 mmHg.
Outcome measures
| Measure |
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
n=2 Participants
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
n=3 Participants
Participants randomized to receive standardized dietary and exercise counseling from a registered dietitian and exercise physiologist.
|
|---|---|---|
|
Diastolic Blood Pressure
Baseline
|
80.00 mmHg
Standard Deviation 2.00
|
80.66 mmHg
Standard Deviation 8.21
|
|
Diastolic Blood Pressure
Month 3
|
74.00 mmHg
Standard Deviation 0.00
|
—
|
|
Diastolic Blood Pressure
Month 6
|
80.00 mmHg
Standard Deviation 0.00
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6Population: The 3-day food recall diary was not completed by any study participants.
Daily caloric intake is measured by 3-day food recall. Mean daily caloric intake is assessed as kilocalories (kcal) consumed per day.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 3, Month 6Population: 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.
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.
Outcome measures
| Measure |
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
n=2 Participants
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
Participants randomized to receive standardized dietary and exercise counseling from a registered dietitian and exercise physiologist.
|
|---|---|---|
|
Change in Anti-hyperglycemic Medication Regimen
No change in dose from Baseline to Month 3
|
1 Participants
|
—
|
|
Change in Anti-hyperglycemic Medication Regimen
Dose Increase from Baseline to Month 3
|
1 Participants
|
—
|
|
Change in Anti-hyperglycemic Medication Regimen
No Change in Dose from Month 3 to Month 6
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Month 1, Month 3, Month 6Population: 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.
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.
Outcome measures
| Measure |
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
n=2 Participants
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
n=3 Participants
Participants randomized to receive standardized dietary and exercise counseling from a registered dietitian and exercise physiologist.
|
|---|---|---|
|
Appetite Visual Analog Scale Score for Hunger
Baseline
|
98 units on a scale
Standard Deviation 2
|
50 units on a scale
Standard Deviation 37.96
|
|
Appetite Visual Analog Scale Score for Hunger
Week 1
|
60.5 units on a scale
Standard Deviation 35.5
|
60.5 units on a scale
Standard Deviation 0.5
|
|
Appetite Visual Analog Scale Score for Hunger
Month 1
|
26.5 units on a scale
Standard Deviation 16.5
|
46 units on a scale
Standard Deviation 3
|
|
Appetite Visual Analog Scale Score for Hunger
Month 3
|
34 units on a scale
Standard Deviation 27
|
—
|
|
Appetite Visual Analog Scale Score for Hunger
Month 6
|
75 units on a scale
Standard Deviation 0
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Month 1, Month 3, Month 6Population: 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.
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.
Outcome measures
| Measure |
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
n=2 Participants
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
n=3 Participants
Participants randomized to receive standardized dietary and exercise counseling from a registered dietitian and exercise physiologist.
|
|---|---|---|
|
Appetite Visual Analog Scale Score for Satisfaction
Baseline
|
2.5 units on a scale
Standard Deviation 2.5
|
19 units on a scale
Standard Deviation 21.95
|
|
Appetite Visual Analog Scale Score for Satisfaction
Week 1
|
37 units on a scale
Standard Deviation 32
|
41.5 units on a scale
Standard Deviation 10.5
|
|
Appetite Visual Analog Scale Score for Satisfaction
Month 1
|
72 units on a scale
Standard Deviation 19
|
41.5 units on a scale
Standard Deviation 11.5
|
|
Appetite Visual Analog Scale Score for Satisfaction
Month 3
|
51 units on a scale
Standard Deviation 20
|
—
|
|
Appetite Visual Analog Scale Score for Satisfaction
Month 6
|
35 units on a scale
Standard Deviation 0
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Month 1, Month 3, Month 6Population: 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.
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.
Outcome measures
| Measure |
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
n=2 Participants
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
n=3 Participants
Participants randomized to receive standardized dietary and exercise counseling from a registered dietitian and exercise physiologist.
|
|---|---|---|
|
Appetite Visual Analog Scale Score for Fullness
Baseline
|
2 units on a scale
Standard Deviation 2
|
19.66 units on a scale
Standard Deviation 21.45
|
|
Appetite Visual Analog Scale Score for Fullness
Week 1
|
37.5 units on a scale
Standard Deviation 33.5
|
28.5 units on a scale
Standard Deviation 21.5
|
|
Appetite Visual Analog Scale Score for Fullness
Month 1
|
77.5 units on a scale
Standard Deviation 20.5
|
36 units on a scale
Standard Deviation 21
|
|
Appetite Visual Analog Scale Score for Fullness
Month 3
|
53.5 units on a scale
Standard Deviation 46.5
|
—
|
|
Appetite Visual Analog Scale Score for Fullness
Month 6
|
14 units on a scale
Standard Deviation 0
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Month 1, Month 3, Month 6Population: 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.
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.
Outcome measures
| Measure |
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
n=2 Participants
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
n=3 Participants
Participants randomized to receive standardized dietary and exercise counseling from a registered dietitian and exercise physiologist.
|
|---|---|---|
|
Appetite Visual Analog Scale Score for Eating Quantity
Baseline
|
74.5 units on a scale
Standard Deviation 25.5
|
42.33 units on a scale
Standard Deviation 13.88
|
|
Appetite Visual Analog Scale Score for Eating Quantity
Week 1
|
38 units on a scale
Standard Deviation 11
|
52.5 units on a scale
Standard Deviation 13.5
|
|
Appetite Visual Analog Scale Score for Eating Quantity
Month 1
|
35 units on a scale
Standard Deviation 10
|
45 units on a scale
Standard Deviation 20
|
|
Appetite Visual Analog Scale Score for Eating Quantity
Month 3
|
31.5 units on a scale
Standard Deviation 7.5
|
—
|
|
Appetite Visual Analog Scale Score for Eating Quantity
Month 6
|
75 units on a scale
Standard Deviation 0
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Month 1, Month 3, Month 6Population: 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.
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.
Outcome measures
| Measure |
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
n=2 Participants
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
n=3 Participants
Participants randomized to receive standardized dietary and exercise counseling from a registered dietitian and exercise physiologist.
|
|---|---|---|
|
Appetite Visual Analog Scale Score for Desire for Certain Foods
Baseline - Sweet
|
23.5 units on a scale
Standard Deviation 23.5
|
49.33 units on a scale
Standard Deviation 40.83
|
|
Appetite Visual Analog Scale Score for Desire for Certain Foods
Week 1 - Sweet
|
37 units on a scale
Standard Deviation 32
|
41.5 units on a scale
Standard Deviation 10.5
|
|
Appetite Visual Analog Scale Score for Desire for Certain Foods
Month 1 - Sweet
|
75 units on a scale
Standard Deviation 13
|
71 units on a scale
Standard Deviation 9
|
|
Appetite Visual Analog Scale Score for Desire for Certain Foods
Month 3 - Sweet
|
42.5 units on a scale
Standard Deviation 7.5
|
—
|
|
Appetite Visual Analog Scale Score for Desire for Certain Foods
Month 6 - Sweet
|
47 units on a scale
Standard Deviation 0
|
—
|
|
Appetite Visual Analog Scale Score for Desire for Certain Foods
Baseline - Salty
|
23 units on a scale
Standard Deviation 23
|
53.33 units on a scale
Standard Deviation 31.75
|
|
Appetite Visual Analog Scale Score for Desire for Certain Foods
Week 1 - Salty
|
57.5 units on a scale
Standard Deviation 11.5
|
57.5 units on a scale
Standard Deviation 12.5
|
|
Appetite Visual Analog Scale Score for Desire for Certain Foods
Month 1 - Salty
|
32 units on a scale
Standard Deviation 8
|
53 units on a scale
Standard Deviation 13
|
|
Appetite Visual Analog Scale Score for Desire for Certain Foods
Month 3 - Salty
|
46.5 units on a scale
Standard Deviation 1.5
|
—
|
|
Appetite Visual Analog Scale Score for Desire for Certain Foods
Month 6 - Salty
|
53 units on a scale
Standard Deviation 0
|
—
|
|
Appetite Visual Analog Scale Score for Desire for Certain Foods
Baseline - Savory
|
11 units on a scale
Standard Deviation 11
|
46 units on a scale
Standard Deviation 36.80
|
|
Appetite Visual Analog Scale Score for Desire for Certain Foods
Week 1 - Savory
|
44 units on a scale
Standard Deviation 22
|
61.5 units on a scale
Standard Deviation 1.5
|
|
Appetite Visual Analog Scale Score for Desire for Certain Foods
Month 1 - Savory
|
71.5 units on a scale
Standard Deviation 2.5
|
62.5 units on a scale
Standard Deviation 11.5
|
|
Appetite Visual Analog Scale Score for Desire for Certain Foods
Month 3 - Savory
|
43.5 units on a scale
Standard Deviation 16.5
|
—
|
|
Appetite Visual Analog Scale Score for Desire for Certain Foods
Month 6 - Savory
|
25 units on a scale
Standard Deviation 0
|
—
|
|
Appetite Visual Analog Scale Score for Desire for Certain Foods
Baseline - Fatty
|
34.5 units on a scale
Standard Deviation 34.5
|
60.66 units on a scale
Standard Deviation 32.26
|
|
Appetite Visual Analog Scale Score for Desire for Certain Foods
Week 1 - Fatty
|
57 units on a scale
Standard Deviation 12
|
38 units on a scale
Standard Deviation 20
|
|
Appetite Visual Analog Scale Score for Desire for Certain Foods
Month 1 - Fatty
|
74.5 units on a scale
Standard Deviation 1.5
|
60.5 units on a scale
Standard Deviation 12.5
|
|
Appetite Visual Analog Scale Score for Desire for Certain Foods
Month 3 - Fatty
|
51.5 units on a scale
Standard Deviation 6.5
|
—
|
|
Appetite Visual Analog Scale Score for Desire for Certain Foods
Month 6 - Fatty
|
70 units on a scale
Standard Deviation 0
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6Population: 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.
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.
Outcome measures
| Measure |
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
n=2 Participants
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
n=3 Participants
Participants randomized to receive standardized dietary and exercise counseling from a registered dietitian and exercise physiologist.
|
|---|---|---|
|
International Physical Activity Questionnaire (IPAQ) Score
Baseline - Low activity
|
0 Participants
|
1 Participants
|
|
International Physical Activity Questionnaire (IPAQ) Score
Baseline - Moderate activity
|
0 Participants
|
2 Participants
|
|
International Physical Activity Questionnaire (IPAQ) Score
Baseline - High activity
|
2 Participants
|
0 Participants
|
|
International Physical Activity Questionnaire (IPAQ) Score
Month 3 - Low activity
|
1 Participants
|
—
|
|
International Physical Activity Questionnaire (IPAQ) Score
Month 3 - Moderate activity
|
1 Participants
|
—
|
|
International Physical Activity Questionnaire (IPAQ) Score
Month 3 - High activity
|
0 Participants
|
—
|
|
International Physical Activity Questionnaire (IPAQ) Score
Month 6 - Low activity
|
2 Participants
|
—
|
|
International Physical Activity Questionnaire (IPAQ) Score
Month 6 - Moderate activity
|
0 Participants
|
—
|
|
International Physical Activity Questionnaire (IPAQ) Score
Month 6 - High activity
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6Population: 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.
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.
Outcome measures
| Measure |
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
n=2 Participants
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
n=3 Participants
Participants randomized to receive standardized dietary and exercise counseling from a registered dietitian and exercise physiologist.
|
|---|---|---|
|
Fasting Glucose Level
Baseline
|
197 mg/dL
Standard Deviation 25
|
166.33 mg/dL
Standard Deviation 4.64
|
|
Fasting Glucose Level
Month 3
|
186.5 mg/dL
Standard Deviation 28.5
|
—
|
|
Fasting Glucose Level
Month 6
|
151.5 mg/dL
Standard Deviation 4.5
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6Population: 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.
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.
Outcome measures
| Measure |
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
n=2 Participants
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
n=3 Participants
Participants randomized to receive standardized dietary and exercise counseling from a registered dietitian and exercise physiologist.
|
|---|---|---|
|
Fasting Insulin Level
Baseline
|
15.9 mIU/L
Standard Deviation 1.6
|
11.6 mIU/L
Standard Deviation 7.65
|
|
Fasting Insulin Level
Month 3
|
16.5 mIU/L
Standard Deviation 4.1
|
—
|
|
Fasting Insulin Level
Month 6
|
18.65 mIU/L
Standard Deviation 6.35
|
—
|
Adverse Events
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
Lifestyle Intervention Only
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
n=2 participants at risk
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
n=3 participants at risk
Participants randomized to receive standardized dietary and exercise counseling from a registered dietitian and exercise physiologist.
|
|---|---|---|
|
Gastrointestinal disorders
Right upper quadrant abdominal pain
|
50.0%
1/2 • 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.
|
0.00%
0/3 • 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.
|
|
General disorders
Dizziness
|
50.0%
1/2 • 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.
|
0.00%
0/3 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place