Diabetic GastroparesisNCT05584462
Gastroparesis in type2 Diabetic Patient
An observational study of Diabetic Gastroparesis, run by Assiut University.
Trial summary
Gastroparesis is defined by objective delaying of gastric emptying without any evidence of mechanical obstruction. Diabetic gastroparesis is a potential complication that occurs in the setting of poorly controlled diabetes, resulting from dysfunction in the coordination and function of the autonomic nervous system… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Diabetic Gastroparesis
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 1 Jan 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: type2 diabetic patient in assiut university hospital
Who may be able to join
- Type 2 DM
- Age < 40 years
- >5 years of DM
Who cannot join
- Type 1 DM
- History of GIT surgry
- Medical disease affect gastric emptying
- Using of prokinetic
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prevalence Of Gastroparesis In Type2 Diabetic Patients In Assiut University Hospital And Value Of Nuclear Imaging In Diagnosis
Gastroparesis is defined by objective delaying of gastric emptying without any evidence of mechanical obstruction. Diabetic gastroparesis is a potential complication that occurs in the setting of poorly controlled diabetes, resulting from dysfunction in the coordination and function of the autonomic nervous system, neurons, and specialized pacemaker cells (interstitial cells of Cajal, ICC) of the stomach and intestine, and the smooth muscle cells of the gastrointestinal tract
Read the detailed description
Hyperglycemia (random blood glucose greater than 200 mg/dL), commonly seen in uncontrolled diabetes, has been associated with diabetic gastroparesis resulting from neuropathy in the setting of chronic hyperglycemia and does not resolve with improved glycemic control. Acute hyperglycemia, on the other hand, though it can also result in delayed gastric emptying, is often reversible with improved glycemic control. Although there is a stronger association between type 1 diabetes and gastroparesis, the incidence of type 2 diabetes is much greater, and therefore, gastroparesis associated with type 2 diabetes is seen more frequently. Additionally, incretin mimetics are used to treat patients with type 2 diabetes, and these medications pose an additional risk factor for developing gastroparesis.Gastric emptying scintigraphy (GES) is the investigation of choice for evaluating the disorders of gastric emptying because it is a simple, physiological, and sensitive investigation to objectively assess gastric emptying. Standard imaging is performed at 0,1,2,4 hours postprandially. A four-hour study is more sensitive and accurate in diagnosing gastroparesis, and clinicians should avoid shortened 2- and 3-hour studies.
- Conditions
- Diabetic Gastroparesis
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of gastroparesis in type 2 diabetic patients
Measured: 3 years
Secondary outcomes (1)
Value of nuclear imaging (Gastric emptying scintigraphy) in diagnosis of gastroparesis
using of Gastric emptying scintigraphy as a tool for diagnosis of gastroparesis
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start1 Nov 2023 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Diabetic GastroparesisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mena Adly Wahba Tous, Assiut University
- Investigators
- Manal Ez Eldin, Study director, Assiut UniversityMarwa Abo kresha, Study director, Assiut UniversityWaleed Ahmed Mohamed, Study director, Assiut Universitymena adly wahba, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584462
- Sponsor's protocol ID
- diabetic gastroparesis
- Status last verified
- Jan 2023
- First submitted
- 10 Oct 2022
- Last updated
- 17 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fehnel S, Fiedorek FT, Nelson L, DiBenedetti D, Spence S, Carson RT. Development and psychometric evaluation of the Diabetic Gastroparesis Symptom Severity Diary. Clin Exp Gastroenterol. 2019 Feb 22;12:93-103. doi: 10.2147/CEG.S184016. eCollection 2019.
PubMed 30863134Chedid V, Halawi H, Brandler J, Burton D, Camilleri M. Gastric accommodation measurements by single photon emission computed tomography and two-dimensional scintigraphy in diabetic patients with upper gastrointestinal symptoms. Neurogastroenterol Motil. 2019 Jun;31(6):e13581. doi: 10.1111/nmo.13581. Epub 2019 Mar 13.
PubMed 30868676Parkman HP, Wilson LA, Hasler WL, McCallum RW, Sarosiek I, Koch KL, Abell TL, Schey R, Kuo B, Snape WJ, Nguyen L, Farrugia G, Grover M, Clarke J, Miriel L, Tonascia J, Hamilton F, Pasricha PJ. Abdominal Pain in Patients with Gastroparesis: Associations with Gastroparesis Symptoms, Etiology of Gastroparesis, Gastric Emptying, Somatization, and Quality of Life. Dig Dis Sci. 2019 Aug;64(8):2242-2255. doi: 10.1007/s10620-019-05522-9. Epub 2019 Mar 9.
PubMed 30852767Revicki DA, Speck RM, Lavoie S, Puelles J, Kuo B, Camilleri M, Almansa C, Parkman HP. The American neurogastroenterology and motility society gastroparesis cardinal symptom index-daily diary (ANMS GCSI-DD): Psychometric evaluation in patients with idiopathic or diabetic gastroparesis. Neurogastroenterol Motil. 2019 Apr;31(4):e13553. doi: 10.1111/nmo.13553. Epub 2019 Feb 7.
PubMed 30734412Abell TL, Kedar A, Stocker A, Beatty K, McElmurray L, Hughes M, Rashed H, Kennedy W, Wendelschafer-Crabb G, Yang X, Fraig M, Omer E, Miller E, Griswold M, Pinkston C. Gastroparesis syndromes: Response to electrical stimulation. Neurogastroenterol Motil. 2019 Mar;31(3):e13534. doi: 10.1111/nmo.13534. Epub 2019 Jan 31.
PubMed 30706646Moshiree B, Potter M, Talley NJ. Epidemiology and Pathophysiology of Gastroparesis. Gastrointest Endosc Clin N Am. 2019 Jan;29(1):1-14. doi: 10.1016/j.giec.2018.08.010.
PubMed 30396519Abokresha MM, Tousb MAW, Elden MEE, Diab WA, Taha BO. Prevalence and clinical determinants of diabetic gastroparesis in type 2 diabetes: a symptom- and scintigraphy-based cross-sectional study. BMC Gastroenterol. 2026 Jun 16;26(1):362. doi: 10.1186/s12876-026-04979-z.
PubMed 42298424
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence Of Gastroparesis In Type2 Diabetic Patients In Assiut University Hospital And Value Of Nuclear Imaging In Diagnosis
- ClinicalTrials.gov ID
- NCT05584462
- Acronym / sponsor ID
- diabetic gastroparesis
- Conditions
- Diabetic Gastroparesis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 18 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gastroparesis is defined by objective delaying of gastric emptying without any evidence of mechanical obstruction. Diabetic gastroparesis is a potential complication that occurs in the setting of poorly controlled diabetes, resulting from dysfunction in the coordination and function of the autonomic nervous system, neurons, and specialized pacemaker cells (interstitial cells of Cajal, ICC) of the stomach and intestine, and the smooth muscle cells of the gastrointestinal tract
Detailed description
Hyperglycemia (random blood glucose greater than 200 mg/dL), commonly seen in uncontrolled diabetes, has been associated with diabetic gastroparesis resulting from neuropathy in the setting of chronic hyperglycemia and does not resolve with improved glycemic control. Acute hyperglycemia, on the other hand, though it can also result in delayed gastric emptying, is often reversible with improved glycemic control. Although there is a stronger association between type 1 diabetes and gastroparesis, the incidence of type 2 diabetes is much greater, and therefore, gastroparesis associated with type 2 diabetes is seen more frequently. Additionally, incretin mimetics are used to treat patients with type 2 diabetes, and these medications pose an additional risk factor for developing gastroparesis.Gastric emptying scintigraphy (GES) is the investigation of choice for evaluating the disorders of gastric emptying because it is a simple, physiological, and sensitive investigation to objectively assess gastric emptying. Standard imaging is performed at 0,1,2,4 hours postprandially. A four-hour study is more sensitive and accurate in diagnosing gastroparesis, and clinicians should avoid shortened 2- and 3-hour studies.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- type2 diabetic patient in assiut university hospital
Key inclusion criteria (3 listed)
- Type 2 DM
- Age < 40 years
- >5 years of DM
Key exclusion criteria (4 listed)
- Type 1 DM
- History of GIT surgry
- Medical disease affect gastric emptying
- Using of prokinetic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prevalence of gastroparesis in type 2 diabetic patients
Time frame: 3 years
1 secondary outcome
Value of nuclear imaging (Gastric emptying scintigraphy) in diagnosis of gastroparesis
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- Background: PubMed 30863134Fehnel S, Fiedorek FT, Nelson L, DiBenedetti D, Spence S, Carson RT. Development and psychometric evaluation of the Diabetic Gastroparesis Symptom Severity Diary. Clin Exp Gastroenterol. 2019 Feb 22;12:93-103. doi: 10.2147/CEG.S184016. eCollection 2019.
- Background: PubMed 30868676Chedid V, Halawi H, Brandler J, Burton D, Camilleri M. Gastric accommodation measurements by single photon emission computed tomography and two-dimensional scintigraphy in diabetic patients with upper gastrointestinal symptoms. Neurogastroenterol Motil. 2019 Jun;31(6):e13581. doi: 10.1111/nmo.13581. Epub 2019 Mar 13.
- Background: PubMed 30852767Parkman HP, Wilson LA, Hasler WL, McCallum RW, Sarosiek I, Koch KL, Abell TL, Schey R, Kuo B, Snape WJ, Nguyen L, Farrugia G, Grover M, Clarke J, Miriel L, Tonascia J, Hamilton F, Pasricha PJ. Abdominal Pain in Patients with Gastroparesis: Associations with Gastroparesis Symptoms, Etiology of Gastroparesis, Gastric Emptying, Somatization, and Quality of Life. Dig Dis Sci. 2019 Aug;64(8):2242-2255. doi: 10.1007/s10620-019-05522-9. Epub 2019 Mar 9.
- Background: PubMed 30734412Revicki DA, Speck RM, Lavoie S, Puelles J, Kuo B, Camilleri M, Almansa C, Parkman HP. The American neurogastroenterology and motility society gastroparesis cardinal symptom index-daily diary (ANMS GCSI-DD): Psychometric evaluation in patients with idiopathic or diabetic gastroparesis. Neurogastroenterol Motil. 2019 Apr;31(4):e13553. doi: 10.1111/nmo.13553. Epub 2019 Feb 7.
- Background: PubMed 30706646Abell TL, Kedar A, Stocker A, Beatty K, McElmurray L, Hughes M, Rashed H, Kennedy W, Wendelschafer-Crabb G, Yang X, Fraig M, Omer E, Miller E, Griswold M, Pinkston C. Gastroparesis syndromes: Response to electrical stimulation. Neurogastroenterol Motil. 2019 Mar;31(3):e13534. doi: 10.1111/nmo.13534. Epub 2019 Jan 31.
- Background: PubMed 30396519Moshiree B, Potter M, Talley NJ. Epidemiology and Pathophysiology of Gastroparesis. Gastrointest Endosc Clin N Am. 2019 Jan;29(1):1-14. doi: 10.1016/j.giec.2018.08.010.
- Derived from this study: PubMed 42298424Abokresha MM, Tousb MAW, Elden MEE, Diab WA, Taha BO. Prevalence and clinical determinants of diabetic gastroparesis in type 2 diabetes: a symptom- and scintigraphy-based cross-sectional study. BMC Gastroenterol. 2026 Jun 16;26(1):362. doi: 10.1186/s12876-026-04979-z.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Manal Ez Eldin study director
Assiut University
Marwa Abo kresha study director
Assiut University
Waleed Ahmed Mohamed study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Gastroparesis, run by Assiut University.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact mena adly wahba (01273858315, Mena.14223961@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of gastroparesis in type 2 diabetic patients (time frame: 3 years). 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 NCT05584462, which also lists 7 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 17 Jan 2023.