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NCT Number: NCT05584462

Gastroparesis in type2 Diabetic Patient

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

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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. prevalence of gastroparesis in type 2 diabetic patients

    Time frame: 3 years

Secondary outcomes

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

    Time frame: 3 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

mena adly wahba

CONTACT

[email protected]

01273858315

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Prevalence Of Gastroparesis In Type2 Diabetic Patients In Assiut University Hospital And Value Of Nuclear Imaging In Diagnosis

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Oct 18, 2022
Registry last updated
Jan 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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