Anatomical and Physiological Characterisation of the Gut Endocrine Cells in Healthy and in Patients With Type 2 Diabetes

Not Applicable

Completed

• Conditions: Type2 Diabetes
• Interventions: Procedure: Double-balloon enteroscopy (DBE) with biopsy retrieval

• Registration Number: NCT03044860
• Lead Sponsor: University Hospital, Gentofte, Copenhagen

Brief Summary

Investigation of the anatomical distribution of enteroendocrine cells by a systematic approach along the entire human intestinal tract in healthy individuals and patients with type 2 diabetes.

Detailed Description

Enteroendocrine K and L cells are pivotal in regulating appetite and glucose homeostasis, but knowledge of their distribution in man is sparse and it is unknown whether alterations occur in type 2 diabetes. Twelve patients with type 2 diabetes and 12 age and BMI-matched healthy individuals underwent upper and lower double-balloon enteroscopy with mucosal biopsy retrieval from every \~30 cm of the small intestine and specific locations in the large intestine. The investigators evaluated the distribution of enteroendocrine cells (using IHC staining for their specific hormonal products) and evaluated mRNA expression of the corresponding genes along the entire intestinal tract in patients with type 2 diabetes and in healthy individuals.

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Study First Submitted: 2017-01-10
• Status Verified: 2017-02
• Study First Submitted QC: 2017-02-02
• Study First Posted: 2017-02-07
• Last Update Submitted: 2017-02-14
• Last Update Posted: 2017-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Type 2 diabetes	Double-balloon enteroscopy (DBE) with biopsy retrieval	Adult patients with type 2 diabetes undergoing double-balloon enteroscopy (DBE) with biopsy retrieval using a DBE-device.
Healthy	Double-balloon enteroscopy (DBE) with biopsy retrieval	Adult subjects without type 2 diabetes undergoing double-balloon enteroscopy (DBE) with biopsy retrieval using a DBE-device.

Primary Outcome Measures

Name	Time	Method
Evaluation of differences in enteroendocrine cells (density and mRNA expression) along the intestinal tract of healthy individuals compared with type 2 diabetes patients.	Cross-sectional study. Each participant went through two study days (upper and lower double-ballon enteroscopy, respectively)	Using a double-balloon enteroscopy device, mucosal biopsies are obtained from the entire intestinal tract in 12 healthy individuals and 12 patients diagnosed with type 2 diabetes. The biopsies are analysed using immunohistochemistry (IHC) and mRNA expression analysis.; Positively stained enteroendocrine cells (from IHC) are counted and divided by the epithelial area providing 'density' (cells/mm2).; Cell count (density) and mRNA expression data obtained from the healthy individuals and type 2 diabetes patietns are compared to evaluate potential differences between the two groups.
Evaluation of enteroendocrine cells (density and mRNA expression) in the intestinal tract.	Cross-sectional study. Each participant went through two study days (upper and lower double-ballon enteroscopy, respectively)	Using a double-balloon enteroscopy device, mucosal biopsies are obtained from the entire intestinal tract in 12 healthy individuals and 12 patients diagnosed with type 2 diabetes. The biopsies are analysed using immunohistochemistry (IHC) and mRNA expression analysis.; Positively stained enteroendocrine cells (from IHC) are counted and divided by the epithelial area providing 'density' (cells/mm2).; The data obtained from cell count and mRNA expression analysis present the variation in number of enteroendocrine cells (density) and the expression of hormonal products along the intestinal tract.