Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Recruiting NCT05624034

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

Conditions: Gastroparesis, Diabetes Complications, Idiopathic Gastric Motility Disorder, Dyspepsia

Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: 1
Enrollment: 140
Sponsor: Asian Institute of Gastroenterology, India

Location: India

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.

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 procedureSubject willing to use appropriate method of contraception as per investigator's discretion, throughout the studyIdiopathic GastroparesisMale 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 procedureSubject willing to use appropriate method of contraception as per investigator's discretion, throughout the studyPatient'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 followingBothersome postprandial fullnessBothersome early satiationBothersome epigastric painBothersome epigastric burning ANDNo 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 diagnosisDiabetic GastroparesisMale 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 procedureSubject willing to use appropriate method of contraception as per investigator's discretion, throughout the studyPatient's having symptoms of dyspepsia based on ROME IV Criteria and Diabetes mellitus of any durationExclusion Criteria:Subjects who meet any of the following criteria will be excluded from the study:For Idiopathic GastroparesisSubjects suffering from DiabetesSubjects with history of any bariatric procedures/ gastric surgeries in the pastFemales who are pregnantSubjects taking following medications within 72 hours to the start of the study: Opioids, TCA, Calcium channel blockers, anti-psychotics, anti-cholinergic, steroids, L-DopaSubjects with electrolyte abnormalities like hypokalaemia, hypomagnesemiaSubjects 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 investigatorFor Diabetic GastroparesisSubjects with history of any bariatric procedures/ gastric surgeries in the pastFemales who are pregnantSubjects taking following medications within 72 hours to the start of the study: Opioids, TCA, Calcium channel blockers, anti-psychotics, anti-cholinergic, steroids, L-DopaSubjects with electrolyte abnormalities like hypokalaemia, hypomagnesemiaSubjects 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05624034). StuddyBuddy aggregates publicly available trial information.