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

November 14, 2022 updated by: Rakesh Kalapala, Asian Institute of Gastroenterology, India

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
    • Telangana
      • Hyderabad, Telangana, India, 500032
        • Recruiting
        • AIG Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EGG findings
Time Frame: 6 months
To study the EGG abnormalities in healthy subjects and in patients with Diabetic and Idiopathic Gastroparesis
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Factors affecting the condition
Time Frame: 6 months
To study factors associated with abnormalities noted in EGG
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asian Institute of Gastroenterology, India

Investigators

  • Study Director: Rakesh Kalapala, MBBS,MD,DM, Senior consultant

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

November 14, 2022

First Submitted That Met QC Criteria

November 14, 2022

First Posted (Actual)

November 21, 2022

Study Record Updates

Last Update Posted (Actual)

November 21, 2022

Last Update Submitted That Met QC Criteria

November 14, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIG/IEC-BH&R32/07.2022-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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