Exploratory study of nutritional status influenced by correlation between pancreas and small intestine

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000014200
• Date of registration: 06/06/2014
• Prospective Registration: No
• Primary sponsor: Nagoya University Graduate School of Medicine
• Public title: Exploratory study of nutritional status influenced by correlation between pancreas and small intestine
• Scientific title: Exploratory study of nutritional status influenced by correlation between pancreas and small intestine - NPI trial
• Date of first enrolment: 2013/09/01
• Target sample size: 300
• Recruitment status: Recruiting
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015983
• Study type: Interventional,observational
• Study design: Parallel Non-randomized
• Phase: Not selected

Countries of recruitment

Japan

Contacts

• Name: Yoshiki Hirooka
• Affiliation: Nagoya University Hospital Department of Endoscopy

• Name: Daijuro Hayashi
• Affiliation: Nagoya University Graduate School of Medicine Department of Gastroenterology and Hepatology

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: Women who may possibly be pregnant or are pregnant. Patients with a history of gastric surgery duodenum. Patients with small bowel surgical history. Patients with ongoing oral administration antiplatelet agent or anticoagulant. Patients with conventional oral administration NSAIDs in. Patients with severe chronic heart failure or severe chronic renal failure. Patients who do not obtain written consent. Others, patient physician-deemed inappropriate.

Age minimum: 20years-old
Age maximum: 90years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Digestive diseases with a focus on pancreatic disease

Intervention(s)

Upper gastrointestinal endoscopy,including the mucosal biopsy and observation of the jejunum with expansion observed with improved small intestine endoscope(SIF-Y0007, Olympus, Tokyo, Japan)
Upper gastrointestinal endoscopy, including the mucosal biopsy and observation of the jejunum with improved small intestine endoscope(SIF-Y0002, Olympus, Tokyo, Japan)
Glucose solution sprayed in the jejunum
Saline spray in the jejunum

Primary Outcome(s)

Search of the small intestinal function and pancreatic function correlation related to nutritional status

Secondary Outcome(s)

1)To evaluate a villus configuration(the degree of atrophy and the density of villus) and the blood flow of villous capillary vessels on endscopic image. 2)To obtain tissues by biopsy, to stain them by hematoxylin and eosin, to measure the height of villus, crypt length, parallel between villus and crypt, glandular cell count, the density of villus, villous capillary veseels inner diameter and square measure and to evaluate a villus configuration quantitatively. 3)To stain the tissues obtained by biopsy immunohistochemical staining(incretin staining(GLP-1 and GIP) and GLP-2R staining) and measure gastrointestinal hormone developing in bowel epithelium and evaluate the function of villus. 4)To evaluate mRNAs(GLP1,2, GIP, GLP2R) by using tissues obtaind by biopsy by real time PCR method and measure gastrointestinal hormone developing in bowel epithelium and evaluate the function of villus. 5)To use an extended observation improvement type small intestine endscope(SIF-Y0007, Olympus medical system, Tokyo Japan) and to evaluate the absorption image of the nutrient(grape carbohydrate solution) in the jejunum villus under extended observation, a change of secondary endpoint[2)-4)] before and after, a comparison between the disease group, pancreatic endocrine and exocrine abilities and the connection with the nourishment state. 6)Nourishment endpoint(BMI, blood examination data). 7)A symptom in conjunction with the pancreas exocrine function imperfection. 8)Subjective symptoms. 9)To evaluate the examination for urine collection C peptide to assume an index of the pancreatic endocrine ability. 10)10)To evaluate an index and the BT-PABA excretion rate(PFD examnation) of the pancreatic exocrine ability. 11)To evaluate the change of villus configuration(the height of villus, crypt length, parallel between villus and crypt, villous capillary veseels inner diameter and paneth cell count) and villous bloodstream over time in comparison with the first enforcement.

Source(s) of Monetary Support

Nagoya University Graduate School of Medicine

Ethics review

Status: YES
Approval date:
Contact: