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
Group
Value
95% CI
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
8.35
± 0.25
Lifestyle Intervention Only
8.86
± 0.40
Month 3
Group
Value
95% CI
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
8.75
± 0.05
Month 6
Group
Value
95% CI
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
8.40
± 0.20
Month 12
Group
Value
95% CI
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
9.30
± 0.0
Insulin Resistance Score Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)Primary· 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).
Baseline
Group
Value
95% CI
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
7.85
± 1.75
Lifestyle Intervention Only
4.70
± 2.94
Month 3
Group
Value
95% CI
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
7.00
± 1.00
Month 6
Group
Value
95% CI
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
10.70
± 1.60
Month 12
Group
Value
95% CI
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
7.00
± 0.0
Number of Deaths Among Recipients of the CryoablationPrimary· Up to Month 12
Mortality among recipients of the cryoablation was documented.
Group
Value
95% CI
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
0
Number of Adverse Events Related to the CryoablationPrimary· 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.
Group
Value
95% CI
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
0
Body Mass Index (BMI)Secondary· Baseline, Month 3, Month 6
Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters.
Baseline
Group
Value
95% CI
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
37.25
± 1.55
Lifestyle Intervention Only
33.26
± 3.71
Month 3
Group
Value
95% CI
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
37.25
± 0.25
Month 6
Group
Value
95% CI
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
Waist circumference is a measurement taken around the abdomen at the level of the umbilicus (belly button). Waist circumference is measured in centimeters.
Baseline
Group
Value
95% CI
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
121.3
± 9.5
Lifestyle Intervention Only
147.66
± 58.39
Month 3
Group
Value
95% CI
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
117.5
± 2.5
Month 6
Group
Value
95% CI
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
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
Group
Value
95% CI
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
0.97
± 0.02
Lifestyle Intervention Only
1.06
± 0.04
Month 3
Group
Value
95% CI
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
0.95
± 0.05
Month 6
Group
Value
95% CI
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
1.0
± 0.0
Total CholesterolSecondary· Baseline, Month 6
A healthy level of total cholesterol is 125 - 200 mg/dL.
Baseline
Group
Value
95% CI
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
198.00
± 39.00
Lifestyle Intervention Only
194.33
± 39.19
Month 6
Group
Value
95% CI
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
A normal diastolic blood pressure level is less than 80 mmHg.
Baseline
Group
Value
95% CI
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
80.00
± 2.00
Lifestyle Intervention Only
80.66
± 8.21
Month 3
Group
Value
95% CI
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
74.00
± 0.00
Month 6
Group
Value
95% CI
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
80.00
± 0.00
Adverse events — posted to ClinicalTrials.gov
Time frame: 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..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Cryoablation of the Vagus Nerve Plus Lifestyle Intervention
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Emory University
Last refreshed: 8 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04276051.