Gastroparesis in type2 Diabetic Patient

Diabetic Gastroparesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05584462
• Other study ID #: diabetic gastroparesis
• Status: Not yet recruiting
• Start date: November 1, 2023
• Est. completion date: January 1, 2027

Study information

• Verified date: January 2023
• Source: Assiut University
• Contact: mena adly wahba
• Phone: 01273858315
• Email: Mena.14223961[@]med.aun.edu.eg
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Gastroparesis
• Gastroparesis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of gastroparesis in type 2 diabetic patients		3 years
Secondary	Value of nuclear imaging (Gastric emptying scintigraphy) in diagnosis of gastroparesis	using of Gastric emptying scintigraphy as a tool for diagnosis of gastroparesis	3 years