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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy group | Subjects with no previous medical history (healthy volunteers) will be assessed for eligibility criteria. |
| |
| 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. |
| |
| Diabetic Gastroparesis | Patients with symptoms of Gastroparesis based on ROME IV criteria and Diabetes mellitus of any duration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrogastrography | Device | Electrogastrography is used to study abnormalities in healthy subjects and in patients with Diabetic and Idiopathic Gastroparesis |
|
| Measure | Description | Time Frame |
|---|---|---|
| EGG findings | To study the EGG abnormalities in healthy subjects and in patients with Diabetic and Idiopathic Gastroparesis | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Factors affecting the condition | To study factors associated with abnormalities noted in EGG | 6 months |
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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:
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40 healthy individuals, 50 diabetic gastroparesis patients and 50 idiopathic gastroparesis will be enrolled in the study as per the inclusion and exclusion criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Neeraj Singla, MBBS,MD,DM | Contact | 7013454913 | docneersk@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Rakesh Kalapala, MBBS,MD,DM | Senior consultant | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AIG Hospitals | Recruiting | Hyderabad | Telangana | 500032 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23762836 | Background | 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. | |
| 29441814 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 29, 2022 | Nov 8, 2022 |
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| Prot_000.pdf |
| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| D048909 | Diabetes Complications |
| D004415 | Dyspepsia |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D012817 | Signs and Symptoms, Digestive |
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