Gastric electrical stimulation results in improved metabolic control in diabetic patients suffering from gastroparesis.
I R van der Voort, J C Becker, K H Dietl...
https://pubmed.ncbi.nlm.nih.gov/15662594/Actively Recruiting
Led by Indiana University · Updated on 2026-06-09
32
Participants Needed
2
Research Sites
113 weeks
Total Duration
This research aims to understand how turning off a Gastric Electrical Stimulator GES affects insulin, C-peptide, GLP-1, and glucose levels in adults with gastroparesis who have had the device implanted for at least three months and are not using prescribed insulin. The study also analyzes heart rate variability through EKG recordings to assess autonomic nervous system activity during device on and off periods. Participants are divided into two groups one with the GES turned off for up to four hours, and a control group where the device remains on. The study involves three consecutive periods a 20-minute baseline with the device on, a four-hour experimental period with the device off or left on for controls, and a 20-minute recovery with the device turned back on. Blood samples are collected multiple times during these periods to measure hormone and glucose levels. During the study, participants lie in bed while EKG electrodes monitor heart function. Researchers analyze blood samples and heart rate data to evaluate changes caused by turning off the stimulator. The study measures effects over up to four hours per participant, with multiple blood draws and continuous heart monitoring to assess hormonal and autonomic changes.
CONDITIONS
Effect of Gastric Electrical Stimulation on Serum Insulin Levels
M
Maureen V Schilling, BA
T
Thomas V Nowak, MD
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Indiana University
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Gastric Electrical Stimulator ON | Gastric Electrical Stimulator OFF (Sham) |
|---|---|---|
| What it is | The GES device remains switched on throughout the experimental session. Participants have stimulation delivered as per device protocol for gastroparesis. | The GES device is switched off for the entire experiment, with no electrical stimulation delivered. This sham condition serves as comparator within the same patients. |
| Role in the trial | Acts as the primary investigational condition to test whether device stimulation alters insulin and hormone levels. | Serves as a sham comparator with the device off, providing a control for physiologic response without active stimulation. |
| Primary use | Used to evaluate whether active GES stimulation influences insulin or other hormone levels during a controlled experimental period. | Used as a sham control to assess baseline hormone levels without electrical stimulation, enabling comparison against the ON condition. |
| How it is given or performed | The GES device remains activated for a controlled session lasting up to 5.5 hours, while participants lie in bed and provide serial blood samples. | The GES device is turned off, and participants undergo the same blood sampling and observation as in the ON condition, ensuring matched procedure except for stimulation. |
| Evidence status | Ongoing clinical investigation; results for this specific ON vs OFF device experiment in nondiabetic gastroparesis patients are not yet established. Prior published evidence exists for GES in diabetic gastroparesis, showing improved metabolic control but not directly in this population. | This sham-control condition allows comparison, but no effect data for the OFF state in nondiabetic gastroparesis patients is published yet. Prior literature focuses on device ON vs OFF responses in other populations. |
| Important limitations | This trial targets a highly selected population: adults with nondiabetic gastroparesis who already have a GES device implanted. Published evidence for GES primarily involves diabetic gastroparesis, limiting the direct generalizability to nondiabetic patients. Device ON vs OFF effects for hormone and glucose outcomes remain investigational here. | The OFF condition is a sham comparator in a crossover design; OFF periods are not representative of routine clinical care, and results are specific to patients who tolerate GES device ON/OFF sequences. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 5.5 hours
Participants lie in bed while the Gastric Electrical Stimulator is either turned off or kept on depending on group assignment. Blood samples are collected multiple times over up to 5.5 hours, and EKG monitoring is performed continuously.
Single visit with multiple blood draws and continuous EKG monitoring
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/33235256/Indiana University
Lead Sponsor