NCT05624034

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 21, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

November 21, 2022

Status Verified

November 1, 2022

Enrollment Period

11 months

First QC Date

November 14, 2022

Last Update Submit

November 14, 2022

Conditions

GastroparesisDiabetes ComplicationsIdiopathic Gastric Motility DisorderDyspepsia

Keywords

gastroparesisdyspepsiagastric myoelectric activity

Outcome Measures

Primary Outcomes (1)

  • EGG findings

    To study the EGG abnormalities in healthy subjects and in patients with Diabetic and Idiopathic Gastroparesis

    6 months

Secondary Outcomes (1)

  • Factors affecting the condition

    6 months

Study Arms (3)

Healthy group

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

Device: Electrogastrography

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

Diabetic Gastroparesis

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

Device: Electrogastrography

Interventions

ElectrogastrographyDEVICE

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

Diabetic GastroparesisHealthy groupIdiopathic Gastroparesis

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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 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 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
  • +6 more criteria

You may not qualify if:

  • 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)
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AIG Hospitals

Hyderabad, Telangana, 500032, India

RECRUITING

Related Publications (2)

  • 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.

    PMID: 23762836BACKGROUND

  • 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.

    PMID: 29441814BACKGROUND

MeSH Terms

Conditions

GastroparesisDiabetes ComplicationsDyspepsia

Condition Hierarchy (Ancestors)

Stomach DiseasesGastrointestinal DiseasesDigestive System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusEndocrine System DiseasesSigns and Symptoms, Digestive

Study Officials

  • Rakesh Kalapala, MBBS,MD,DM

    Senior consultant

    STUDY DIRECTOR

Central Study Contacts

Neeraj Singla, MBBS,MD,DM

CONTACT

7013454913docneersk@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Endoscopy[ Center for obesity and metabolic therapy]

Study Record Dates

First Submitted

November 14, 2022

First Posted

November 21, 2022

Study Start

November 1, 2022

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

November 21, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)