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Gastroparesis in type2 Diabetic Patient

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05584462
Collaborator
(none)
100
Enrollment
38
Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Prevalence Of Gastroparesis In Type2 Diabetic Patients In Assiut University Hospital And Value Of Nuclear Imaging In Diagnosis
    Anticipated Study Start Date :
    Nov 1, 2023
    Anticipated Primary Completion Date :
    Jan 1, 2026
    Anticipated Study Completion Date :
    Jan 1, 2027

    Outcome Measures

    Primary Outcome Measures

    1. prevalence of gastroparesis in type 2 diabetic patients [3 years]

    Secondary Outcome Measures

    1. Value of nuclear imaging (Gastric emptying scintigraphy) in diagnosis of gastroparesis [3 years]

      using of Gastric emptying scintigraphy as a tool for diagnosis of gastroparesis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Type 2 DM

    2. Age < 40 years

    3. 5 years of DM

    Exclusion Criteria:

    1. Type 1 DM

    2. History of GIT surgry

    3. Medical disease affect gastric emptying

    4. Using of prokinetic

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Study Director: Manal Ez Eldin, Assiut University
    • Study Director: Marwa Abo kresha, Assiut University
    • Study Director: Waleed Ahmed Mohamed, Assiut University
    • Principal Investigator: mena adly wahba, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mena Adly Wahba Tous, Assistant Lecturer, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05584462
    Other Study ID Numbers:
    • diabetic gastroparesis
    First Posted:
    Oct 18, 2022
    Last Update Posted:
    Jan 17, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Gastroparesis

    Study Results

    No Results Posted as of Jan 17, 2023