Gastroparesis

The following are the inclusion criteria: (1) age 50–70 years, (2) full cognitive capacity, (3) tolerance of intestinal preparation and colon examination, (4) patients undergoing colonoscopy, and (5) patients who agreed to participate, take research drugs as instructed, and sign informed content.
The following are the exclusion criteria: (1) participants who are allergic to any component of the experimental drug; (2) participants who cannot tolerate ordinary colonoscopy; (3) participants who have used research drugs, other intestinal preparations, or drugs that affect gastrointestinal motility within 7 days from the start of the trial; (4) participants who are diagnosed or suspected to have gastrointestinal obstruction, gastric retention, gastroparesis, disturbance of gastric emptying, or acute gastrointestinal bleeding; (5) participants with suspected abdominal organ perforation, including gastric perforation, intestinal perforation, and appendix perforation; (6) participants with a history of major gastrointestinal surgery; (7) women with positive pregnancy tests or pregnancy plans during the screening period; (8) participants with neurological diseases; (9) patients with severe heart disease or electrolyte imbalance that is difficult to correct; and (10) participants in other clinical trials within the last 3 months.

The secondary endpoint, which is adverse events related to endoscopic tattooing, such as perforation, abscess formation, peritonitis, post-tattoo fever, post-tattoo abdominal pain, and intraperitoneal spillage of tattooing agent, will be evaluated in autologous blood group. Surgery related complications include peritoneal effusion or abscess formation, hemorrhage (inside abdominal cavity, inside digestive tract), ileus, anastomotic leakage, intestinal fistula, lymphatic leakage, gastroparesis, pancreatitis, lung infection, pleural effusion, urinary tract infection, renal failure, liver failure, cardio-cerebrovascular events (both lower extremities thrombosis, pulmonary embolism, myocardial infarction, arrhythmia, cerebral infarction, etc.), and others. Surgical complications will be evaluated in both groups. Complications will be reported and graded according to the Clavien-Dindo classification of surgical complications.Fig. 1

CONSORT diagram

This study comprised 100 adult patients with T2D and 50 age- and sex-matched healthy controls. Patients with T2D were consecutively recruited from Diabetes Outpatient Clinic at Mansoura Specialized Medical Hospital, Mansoura University, Mansoura, Egypt. The inclusion criteria were patients with duration of T2D > 10 years and who had symptoms of gastroparesis [Gastroparesis Cardinal Symptom Index (GCSI) Score ≥ 1.9]. Patients with T2D were submitted for transabdominal ultrasonography accordingly, they divided into 2 groups: patients with gastroparesis (n = 55) and patients without gastroparesis (n = 45). Exclusion criteria were history of digestive tract surgery or prior gastric outlet obstruction, thyroid disease, liver & renal failure, neuropsychiatric disorder, connective tissue disorders, malignancies, pregnancy and participants taking vitamin B12 and alcohol. Drugs that could potentially interfere with gastrointestinal motility such as GLP-1 receptor agonists and the amylin analog, α glucosidase inhibitors, and opioid analgesic were also excluded. Healthy controls were recruited from the same geographic area with the same exclusion criteria.
All participants were subjected to a thorough medical history and underwent a clinical examination. Anthropometric measurements including height, body weight, body mass index (BMI) (kg/m²), and waist circumference (WC) were obtained using standardized techniques. The diagnosis of diabetic gastroparesis was based on the symptom validated questionnaire GCSI Score ≥ 1.9 and ultrasonographic findings including gastric emptying ˂ 35.67% and motility index ˂ 5.1. The cut-off point of gastric emptying and motility index were calculated from our study healthy controls as mean—2SD.
The GCSI Score consists of 9 symptoms covering 3 areas; nausea/vomiting subscale (3 symptoms: nausea, vomiting and retching), postprandial fullness/early satiety subscale (4 symptoms: stomach fullness, early satiety, postprandial fullness and loss of appetite) and bloating subscale (2 symptoms: bloating and stomach distension). All symptoms are rated from 0 to 5 over the prior 2 weeks [no symptoms = 0, very mild = 1, mild = 2, moderate = 3, severe = 4, and very severe = 5]. GCSI Score was calculated as the average of the 3 symptom subscales [17 (link)]. The clinical severity of gastroparesis was graded on a scale originally proposed by Abell et al. [18 (link)]; grade 1: mild gastroparesis (symptoms are relatively easily controlled and weight and nutrition can be maintained with a regular diet); grade 2: compensated gastroparesis (symptoms are partially controlled with the use of daily medications and nutrition can be maintained with dietary adjustments); grade 3: gastroparesis with gastric failure (uncountable refractory symptoms with frequent hospitalizations and/or inability to maintain nutrition via an oral route).
Vitamin B12 deficiency was defined as vitamin B12 levels below 125 pmol/L [16 (link)]. Peripheral neuropathy was diagnosed based on neuropathy disability and symptom scores [19 (link), 20 (link)]. Diabetic nephropathy was diagnosed according to Umanath & Lewis [21 (link)]. Diabetic retinopathy was assessed through fundus examination.