Clinical trial NCT05584462: Gastroparesis in type2 Diabetic Patient
Official title: Prevalence Of Gastroparesis In Type2 Diabetic Patients In Assiut University Hospital And Value Of Nuclear Imaging In Diagnosis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diabetic Gastroparesis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-10-18
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: type2 diabetic patient in assiut university hospital

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: prevalence of gastroparesis in type 2 diabetic patients
timeFrame: 3 years
Secondary outcomes:
measure: Value of nuclear imaging (Gastric emptying scintigraphy) in diagnosis of gastroparesis
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Manal Ez Eldin
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Marwa Abo kresha
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Waleed Ahmed Mohamed
role: STUDY_DIRECTOR
affiliation: Assiut University
name: mena adly wahba
role: PRINCIPAL_INVESTIGATOR
References:
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