Effect of Gastric Electrical Stimulation on Serum Insulin Levels

NCT07635576 | Recruiting FDA Device

• 1 other identifier: 30020
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this observational study is to determine how much effect turning the subject's Gastric Electrical Stimulator off for up to four hours will have on levels of insulin, C-peptide, GLP-1 and Glucose levels in patients with gastroparesis who have had a GES for at least three months, who are not taking diabetic prescribed exogenous insulin. EKG recordings will be made and analyzed for Heart Rate Variability and Power Spectral Analysis.

Conditions

Gastroparesis Nondiabetic

Outcome Measures

Primary Outcomes (1)

• Definition of Effect

  To define the effect of prolonged four-hour withdrawal of gastric electrical stimulation on serum insulin and C-peptide levels in human subjects. Insulin and C-peptide are co-primary end points.

  Up to four hours depending on the subject's preference/tolerability.

Secondary Outcomes (3)

• Comparing Hormone Levels

  Up to four hours depending on the subject's preference/tolerability.

• Definition of 4-Hour Withdrawl of GES Device

  Up to four hours depending on the subject's preference/tolerability.

• Changes in Glucose and GLP-1 Levels

  Up to four hours depending on the subject's preference/tolerability.

Other Outcomes (1)

• Tertiary Objective

  Up to four hours depending on the subject's preference/tolerability.

Study Arms (2)

The OFF Group

EXPERIMENTAL

This group of subjects will have their GES interrogated and observed as well as having the device turned off for the duration of the experiment. The device will then be re-interrogated and turned back on at the end of the experiment.

Device: Gastric Electrical Stimulator

SHAM Group

SHAM COMPARATOR

This group of subjects will have their GES interrogated and observed yet will not have the device turned off for the duration of the experiment. The device will then be re-interrogated at the end of the experiment. This is to retain the illusion of the device being turned back on.

Device: Gastric Electrical Stimulator

Interventions

Gastric Electrical Stimulator DEVICE

Device will either be turned off for the duration of the experiment, or the device will be left on for the duration of the experiment

Also known as: GES

SHAM Group; The OFF Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age.
• Documented diagnosis of gastroparesis
• Not taking diabetic prescribed exogenous insulin.
• Patient has a GES device that has been implanted for at least 3 months.
• Willing to give up to 8 blood samples.
• Willing to lie in a bed for up to 5.5 hours.

You may not qualify if:

• Pregnancy
• History of allergic reaction to EKG lead placement adhesives.
• Unable to give informed consent.
• Unwilling to give up to 8 5 ml blood samples.
• Unwilling to lie in a bed for up to 5.5 hours.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (2)

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

RECRUITING

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

RECRUITING

Related Publications (5)

• Payne SC, Ward G, Fallon JB, Hyakumura T, Prins JB, Andrikopoulos S, MacIsaac RJ, Villalobos J. Blood glucose modulation and safety of efferent vagus nerve stimulation in a type 2 diabetic rat model. Physiol Rep. 2022 Apr;10(8):e15257. doi: 10.14814/phy2.15257.

  PMID: 35439355 BACKGROUND

• Kozorosky EM, Lee CH, Lee JG, Nunez Martinez V, Padayachee LE, Stauss HM. Transcutaneous auricular vagus nerve stimulation augments postprandial inhibition of ghrelin. Physiol Rep. 2022 Apr;10(8):e15253. doi: 10.14814/phy2.15253.

  PMID: 35441808 BACKGROUND

• Vosseler A, Zhao D, Fritsche L, Lehmann R, Kantartzis K, Small DM, Peter A, Haring HU, Birkenfeld AL, Fritsche A, Wagner R, Preissl H, Kullmann S, Heni M. No modulation of postprandial metabolism by transcutaneous auricular vagus nerve stimulation: a cross-over study in 15 healthy men. Sci Rep. 2020 Nov 24;10(1):20466. doi: 10.1038/s41598-020-77430-2.

  PMID: 33235256 BACKGROUND

• van der Voort IR, Becker JC, Dietl KH, Konturek JW, Domschke W, Pohle T. Gastric electrical stimulation results in improved metabolic control in diabetic patients suffering from gastroparesis. Exp Clin Endocrinol Diabetes. 2005 Jan;113(1):38-42. doi: 10.1055/s-2004-830525.

  PMID: 15662594 BACKGROUND

• Hampton RF, Jimenez-Gonzalez M, Stanley SA. Unravelling innervation of pancreatic islets. Diabetologia. 2022 Jul;65(7):1069-1084. doi: 10.1007/s00125-022-05691-9. Epub 2022 Mar 29.

  PMID: 35348820 RESULT

Related Links

• Block Randomization in Clinical Trials: Video Tutorial in Microsoft Excel

Study Officials

• Thomas V Nowak, MD

  IU School of Medicine/IU Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maureen V Schilling, BA

CONTACT

3172782064; maschi@iu.edu

Thomas V Nowak, MD

CONTACT

3179484272; tvnowak@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: One group will have their GES turned off for the duration of the experiment, and the second group will not have their GES turned off, but will not know of this as the device will be interrogated and observed in the same manner as the OFF group, except the device will not be turned off.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: To define the effect of prolonged four-hour withdrawal of gastric electrical stimulation on serum insulin and C-peptide levels in human subjects. Insulin and C-peptide are co-primary end points.

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 9, 2026
• Study Start: June 8, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): September 30, 2030
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)