Clinical trial NCT05624034: To Study the EGG Abnormalities in Healthy Subjects and in Patients With Idiopathic and Diabetic Gastroparesis.
Official title: To Study the Electrogastrography [EGG]Abnormalities in Healthy Subjects and in Patients With Idiopathic and Diabetic Gastroparesis: A Prospective Single Center Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastroparesis
Diabetes Complications
Idiopathic Gastric Motility Disorder
Dyspepsia
Keywords: gastroparesis
dyspepsia
gastric myoelectric activity
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2022-11-21
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 40 healthy individuals, 50 diabetic gastroparesis patients and 50 idiopathic gastroparesis will be enrolled in the study as per the inclusion and exclusion criteria.

Brief summary: Electrogastrogram (EGG) is a non-invasive method for recording myoelectric activities by placing electrodes on the abdomen surface. Many studies suggested EGG measures the gastric slow wave frequency effectively; the relative change in EGG signal amplitude would reflect the contractility of the stomach. Thus, this technique is used to study the pathophysiological processes of diseases such as functional dyspepsia and many more .

The present study aims to study the EGG pattern in healthy individuals in Indian population and the factors associated with it.

Detailed description: Electrogastrogram \[EGG\] is an authentic method to detect gastrointestinal diseases accompanied by gastric motility abnormalities . The present study would help to determine the normatic values of EGG in healthy population and EGG changes in patients with idiopathic gastroparesis. This pilot study would provide findings/abnormalities seen in study population and may be helpful in providing a comparative data for proper treatment and a better quality of life patients suffering from dyspepsia.

All the eligible subjects will undergo study procedure i.e. EGG. The study procedure will conduct as per standard study protocol. EGG is a non-invasive, painless method for the measurement of gastric myoelectrical activity. EGG takes around two hours to complete the procedure and no side effects reported. Following steps are included in the procedure

* Subject lie on back on a procedure table.
* Investigator or technician tapes electrodes to Subject's abdomen (belly). The electrodes are similar to those used for other tests, such as an ECG (electrocardiogram). The electrodes measure electrical signals coming from stomach muscles. They send the signals to a computer that records the signals as a graph.
* Investigator or technician records a test while Subject's stomach is empty. An hour later, Subject have something to eat and drink. Investigator or technician then records a second test. The test and electrodes are painless.
* The electrodes are removed. EGG test is completed at this point.

Eligibility criteria: Inclusion Criteria:

* Subjects must meet the following criteria to be included in the study:
* Healthy subjects 20 Males and 20 females subjects atleast one will be taken from each group \[18-20,20-30,30-40,40-50,50-60,60-70yrsAbsence of previous upper gastrointestinal surgery anytime in past.
* Absence of drugs which affect the upper gastrointestinal system in 3 months.
* Absence of diabetes,thyroid disorder or neuromuscular disorder.
* Subject who has read the informed consent form, has understood the relevant aspects of the study, and grants his/her authorization to participate by signing the informed consent form before the inclusion in the study and the performance of any procedure
* Subject willing to use appropriate method of contraception as per investigator's discretion, throughout the study
* Idiopathic Gastroparesis
* Male and female subjects above 18 to 70 years of age.
* Subject who has read the informed consent form, has understood the relevant aspects of the study, and grants his/her authorization to participate by signing the informed consent form before the inclusion in the study and the performance of any procedure
* Subject willing to use appropriate method of contraception as per investigator's discretion, throughout the study
* Patient's having symptoms of dyspepsia based on ROME IV Criteria and not having a known cause of gastroparesis like endocrine, neurological, rheumatological disorder.
* ROME IV criteria for Functional Dyspepsia\* (Diagnostic criteria\*\*): One or more of the following
* Bothersome postprandial fullness
* Bothersome early satiation
* Bothersome epigastric pain
* Bothersome epigastric burning AND
* No evidence of structural disease (including at upper endoscopy) that is likely to explain the symptoms

  -\*Must fulfill criteria for Postprandial Distress Syndrome (PDS) and/or Epigastric Pain Syndrome (EPS)

  -\*\*Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis
* Diabetic Gastroparesis
* Male and female subjects above 18 to 70 years of age.
* Subject who has read the informed consent form, has understood the relevant aspects of the study, and grants his/her authorization to participate by signing the informed consent form before the inclusion in the study and the performance of any procedure
* Subject willing to use appropriate method of contraception as per investigator's discretion, throughout the study
* Patient's having symptoms of dyspepsia based on ROME IV Criteria and Diabetes mellitus of any duration

Exclusion Criteria:

* Subjects who meet any of the following criteria will be excluded from the study:
* For Idiopathic Gastroparesis
* Subjects suffering from Diabetes
* Subjects with history of any bariatric procedures/ gastric surgeries in the past
* Females who are pregnant
* Subjects taking following medications within 72 hours to the start of the study: Opioids, TCA, Calcium channel blockers, anti-psychotics, anti-cholinergic, steroids, L-Dopa
* Subjects with electrolyte abnormalities like hypokalaemia, hypomagnesemia
* Subjects with known cases of thyroid disorder (hypo or hyperthyroidism)
* Subjects who are unsuitable for any other reason to participate in the study in the opinion of the investigator
* For Diabetic Gastroparesis
* Subjects with history of any bariatric procedures/ gastric surgeries in the past
* Females who are pregnant
* Subjects taking following medications within 72 hours to the start of the study: Opioids, TCA, Calcium channel blockers, anti-psychotics, anti-cholinergic, steroids, L-Dopa
* Subjects with electrolyte abnormalities like hypokalaemia, hypomagnesemia
* Subjects with known cases of thyroid disorder (hypo or hyperthyroidism)
* Subjects who are unsuitable for any other reason to participate in the study in the opinion of the investigator.

Primary outcomes:
measure: EGG findings
timeFrame: 6 months
Secondary outcomes:
measure: Factors affecting the condition
timeFrame: 6 months
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: AIG Hospitals
state: Telangana
Study officials:
affiliation: Senior consultant
name: Rakesh Kalapala, MBBS,MD,DM
role: STUDY_DIRECTOR
References:
citation: Riezzo G, Russo F, Indrio F. Electrogastrography in adults and children: the strength, pitfalls, and clinical significance of the cutaneous recording of the gastric electrical activity. Biomed Res Int. 2013;2013:282757. doi: 10.1155/2013/282757. Epub 2013 May 25.
citation: Al Kafee A, Akan A. Analysis of gastric myoelectrical activity from the electrogastrogram signals based on wavelet transform and line length feature. Proc Inst Mech Eng H. 2018 Apr;232(4):403-411. doi: 10.1177/0954411918757812. Epub 2018 Feb 14.