Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Obesity and Insulin Resistance

Completed · Not applicable · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2, Obesity

In brief

Being overweight or obese has been associated with insulin resistance contributing to an increased risk for the development of type II diabetes. Food intake, metabolic rate, and blood glucose levels are regulated by the autonomic nervous system, including the vagus nerve. This study evaluates the hypothesis that non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) affects hormones that regulate food intake and blood glucose levels in a way that is consistent with reduced food intake and lower blood glucose levels. The investigators further hypothesize that these effects of taVNS depend on body weight. In a cross-over design generally healthy study participants will receive either taVNS or a sham intervention for 30 minutes on two separate study days. The order of the intervention on the two study days will be randomized and the two study days are at least one week apart. Based on body mass index (BMI) study participants are assigned to either a normal weight (BMI\<25), overweight (BMI\<30), or obese (BMI\>30) group. Capillary blood samples taken by finger prick before and after the intervention on each study day will be analyzed for blood glucose concentration and hormones that are linked to food intake and blood glucose levels. In addition, autonomic function will be assessed by heart rate variability analysis of ECG recordings obtained before, during, and after the intervention on each study day.

Key facts

Study ID

NCT04926415

Run by

Burrell College of Health Sciences

People needed

30

Starts

2021-06-14

Expected to finish

2022-04-26

Last updated by the study team

2022-04-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Generally healthy

You may not qualify if…

• Age under 18 years
• Pregnancy
• Acute illnesses/fever
• Any medication that interferes with the autonomic nervous system (e.g., beta blockers)
• Any medication that interferes with glucose metabolism (e.g., antidiabetic drugs)
• Any medication that interferes with lipid metabolism (e.g., statins)
• Any medical conditions that interfere with the autonomic nervous system
• Type 1 or Type 2 diabetes
• Epilepsy
• Cardiac conditions, including arrhythmia
• Vestibulocochlear neuronitis or nerve damage (e.g., hearing loss or tinnitus)
• Skin irritation/inflammation at the stimulation site at the ear
• Current drug or alcohol abuse

Where it is running

• Burrell College of Osteopathic Medicine — Las Cruces, New Mexico, United States

Full record on ClinicalTrials.gov

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