NCT05584462

Brief 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, neurons, and specialized pacemaker cells (interstitial cells of Cajal, ICC) of the stomach and intestine, and the smooth muscle cells of the gastrointestinal tract

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Nov 2023

Typical duration for all trials

Status
not yet recruiting

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 Progress79%
Nov 2023Jan 2027

First Submitted

Initial submission to the registry

October 10, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 18, 2022

Completed
1 year until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Expected
Last Updated

January 17, 2023

Status Verified

January 1, 2023

Enrollment Period

2.2 years

First QC Date

October 10, 2022

Last Update Submit

January 13, 2023

Conditions

Diabetic Gastroparesis

Outcome Measures

Primary Outcomes (1)

  • prevalence of gastroparesis in type 2 diabetic patients

    3 years

Secondary Outcomes (1)

  • Value of nuclear imaging (Gastric emptying scintigraphy) in diagnosis of gastroparesis

    3 years

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

type2 diabetic patient in assiut university hospital

You may qualify if:

  • Type 2 DM
  • Age \< 40 years
  • \>5 years of DM

You may not qualify if:

  • Type 1 DM
  • History of GIT surgry
  • Medical disease affect gastric emptying
  • Using of prokinetic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 30863134BACKGROUND

  • Chedid 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.

    PMID: 30868676BACKGROUND

  • Parkman 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.

    PMID: 30852767BACKGROUND

  • Revicki 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.

    PMID: 30734412BACKGROUND

  • Abell 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.

    PMID: 30706646BACKGROUND

  • Moshiree 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.

    PMID: 30396519BACKGROUND

Study Officials

  • Manal Ez Eldin

    Assiut University

    STUDY DIRECTOR

  • Marwa Abo kresha

    Assiut University

    STUDY DIRECTOR

  • Waleed Ahmed Mohamed

    Assiut University

    STUDY DIRECTOR

  • mena adly wahba

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

mena adly wahba

CONTACT

01273858315Mena.14223961@med.aun.edu.eg

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

October 10, 2022

First Posted

October 18, 2022

Study Start

November 1, 2023

Primary Completion

January 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

January 17, 2023

Record last verified: 2023-01