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GastroparesisNCT05624034

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

An observational study of Gastroparesis and Diabetes Complications, run by Asian Institute of Gastroenterology, India at 1 site in India.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
What is being tested?
Electrogastrography
How many people
140 participants
Where
1 siteIndia
Study dates
1 Nov 2022to Oct 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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
Show all 24Show fewer
  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Neeraj Singla, MBBS,MD,DM contact

7013454913

docneersk@gmail.com

India1 site, 1 recruiting

  • AIG Hospitals

    Hyderabad, Telangana, 500032

    Recruiting

Other trials in India

About this study

Official title: 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.

Read the 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.
Being tested
Electrogastrography
Keywords
gastroparesis, dyspepsia, gastric myoelectric activity
Medical subject headings
Gastroparesis, Diabetes Complications, Dyspepsia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ElectrogastrographyDevice

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

Study groups in NCT05624034
Study groupRoleWhat they receive
Healthy groupSubjects with no previous medical history (healthy volunteers) will be assessed for eligibility criteria.
Receives: Device: Electrogastrography
Idiopathic GastroparesisPatients with symptoms of Gastroparesis based on ROME IV criteria and not having a known cause of gastroparesis like endocrine, neurological, rheumatological disorder.
Receives: Device: Electrogastrography
Diabetic GastroparesisPatients with symptoms of Gastroparesis based on ROME IV criteria and Diabetes mellitus of any duration.
Receives: Device: Electrogastrography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. EGG findings

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

    Measured: 6 months

Secondary outcomes (1)

  1. Factors affecting the condition

    To study factors associated with abnormalities noted in EGG

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2022
  2. Study start1 Nov 2022
  3. Primary completionOct 2023 (estimated)
  4. Study completionOct 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05624034
Sponsor's protocol ID
AIG/IEC-BH&R32/07.2022-03
Status last verified
Nov 2022
First submitted
14 Nov 2022
Last updated
21 Nov 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 23762836

  • 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.

    PubMed 29441814

Questions about this trial

What is this clinical trial studying?

An observational study of Gastroparesis and Diabetes Complications, run by Asian Institute of Gastroenterology, India at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Neeraj Singla, MBBS,MD,DM (7013454913, docneersk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EGG findings (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05624034, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2022.

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