To Study the EGG Abnormalities in Healthy Subjects and in Patients With Idiopathic and Diabetic Gastroparesis.

Sponsor

Asian Institute of Gastroenterology, India (Other)

Overall Status

Recruiting

CT.gov ID

NCT05624034

Collaborator

(none)

140

Enrollment

Location

Anticipated Duration (Months)

12.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastroparesis Diabetes Complications Idiopathic Gastric Motility Disorder Dyspepsia	Device: Electrogastrography

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

140 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

To Study the Electrogastrography [EGG]Abnormalities in Healthy Subjects and in Patients With Idiopathic and Diabetic Gastroparesis: A Prospective Single Center Study.

Actual Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Healthy group Subjects with no previous medical history (healthy volunteers) will be assessed for eligibility criteria.	Device: Electrogastrography Electrogastrography is used to study abnormalities in healthy subjects and in patients with Diabetic and Idiopathic Gastroparesis
Idiopathic Gastroparesis Patients with symptoms of Gastroparesis based on ROME IV criteria and not having a known cause of gastroparesis like endocrine, neurological, rheumatological disorder.	Device: Electrogastrography Electrogastrography is used to study abnormalities in healthy subjects and in patients with Diabetic and Idiopathic Gastroparesis
Diabetic Gastroparesis Patients with symptoms of Gastroparesis based on ROME IV criteria and Diabetes mellitus of any duration.	Device: Electrogastrography Electrogastrography is used to study abnormalities in healthy subjects and in patients with Diabetic and Idiopathic Gastroparesis

Arm

Intervention/Treatment

Healthy group

Subjects with no previous medical history (healthy volunteers) will be assessed for eligibility criteria.

Device: Electrogastrography

Electrogastrography is used to study abnormalities in healthy subjects and in patients with Diabetic and Idiopathic Gastroparesis

Idiopathic Gastroparesis

Patients with symptoms of Gastroparesis based on ROME IV criteria and not having a known cause of gastroparesis like endocrine, neurological, rheumatological disorder.

Device: Electrogastrography

Electrogastrography is used to study abnormalities in healthy subjects and in patients with Diabetic and Idiopathic Gastroparesis

Diabetic Gastroparesis

Patients with symptoms of Gastroparesis based on ROME IV criteria and Diabetes mellitus of any duration.

Device: Electrogastrography

Electrogastrography is used to study abnormalities in healthy subjects and in patients with Diabetic and Idiopathic Gastroparesis

Outcome Measures

Primary Outcome Measures

EGG findings [6 months]
To study the EGG abnormalities in healthy subjects and in patients with Diabetic and Idiopathic Gastroparesis

Secondary Outcome Measures

Factors affecting the condition [6 months]
To study factors associated with abnormalities noted in EGG

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.