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

NCT03044860 | Completed DMC

• 1 other identifier: Endocrinemapping
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (2)

• Evaluation of enteroendocrine cells (density and mRNA expression) in the intestinal tract.

  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.

  Cross-sectional study. Each participant went through two study days (upper and lower double-ballon enteroscopy, respectively)

• Evaluation of differences in enteroendocrine cells (density and mRNA expression) along the intestinal tract of healthy individuals compared with type 2 diabetes patients.

  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.

  Cross-sectional study. Each participant went through two study days (upper and lower double-ballon enteroscopy, respectively)

Study Arms (2)

Type 2 diabetes

EXPERIMENTAL

Adult patients with type 2 diabetes undergoing double-balloon enteroscopy (DBE) with biopsy retrieval using a DBE-device.

Procedure: Double-balloon enteroscopy (DBE) with biopsy retrieval

Healthy

EXPERIMENTAL

Adult subjects without type 2 diabetes undergoing double-balloon enteroscopy (DBE) with biopsy retrieval using a DBE-device.

Procedure: Double-balloon enteroscopy (DBE) with biopsy retrieval

Interventions

Double-balloon enteroscopy (DBE) with biopsy retrieval PROCEDURE

With the use of a double-balloon enteroscopy device, study participants underwent upper and lower enteroscopies with mucosal biopsy mucosal biopsy retrieval from every \~30 cm of the small intestine and specific locations in the large intestine

Healthy; Type 2 diabetes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes patients
• Treatment with diet counseling alone or combined with an glucose-lowering drugs: metformin or sulphonylurea
• Caucasian ethnicity
• Age \>25 and \<70 years
• Normal hemoglobin
• Negative for autoantibodies to glutamic acid decarboxylase (GAD-65) and islet cell autoantibodies (ICA).
• Healthy individuals
• Fasting plasma glucose \<6.0 mM
• Plasma glucose 2 hours after a 75 g-oral glucose tolerance test \<7.8 mM
• Negative for GAD-65 antibodies and ICA
• Caucasian ethnicity
• Age \>25 and \<70 years
• Normal hemoglobin

You may not qualify if:

• Type 2 diabetes patients
• Liver disease (evaluated by alanine aminotransferase and/or aspartate aminotransferase \>2 times normal value)
• Treatment with dipeptidyl peptidase 4 inhibitors or medicine that could not be paused for 12 hours
• Previous hysterectomy, appendectomy, cholecystectomy or caesarean
• Sleep apnea
• American Society of Anesthesiologists class \>3
• Allergy to soy protein or eggs
• BMI \>35 kg/m2 or any other condition that would contraindicate propofol sedation or enteroscopy.
• Healthy individuals
• Liver disease (evaluated by alanine aminotransferase and/or aspartate aminotransferase \>2 times normal value)
• Liver disease (evaluated by alanine aminotransferase and/or aspartate aminotransferase \>2 times normal value)
• Treatment with dipeptidyl peptidase 4 inhibitors or medicine that could not be paused for 12 hours
• Previous hysterectomy, appendectomy, cholecystectomy or caesarean
• Sleep apnea
• American Society of Anesthesiologists class \>3

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead

Related Publications (5)

• Gilliam-Vigh H, Ellegaard AM, Madsen MR, Lund AB, Jensen BAH, Vilsboll T, Rigbolt K, Knop FK. Mucosal transcriptomic landscape along the small and large intestines in individuals with and without type 2 diabetes. Gut. 2025 Dec 5;75(1):33-45. doi: 10.1136/gutjnl-2024-334124.

  PMID: 40803750 DERIVED

• Gilliam-Vigh H, Suppli MP, Heimburger SMN, Lund AB, Knop FK, Ellegaard AM. Cholesin mRNA Expression in Human Intestinal, Liver, and Adipose Tissues. Nutrients. 2025 Feb 8;17(4):619. doi: 10.3390/nu17040619.

  PMID: 40004948 DERIVED

• Gilliam-Vigh H, Jorsal T, Nielsen SW, Forman JL, Pedersen J, Poulsen SS, Vilsboll T, Knop FK. Expression of Secretin and its Receptor Along the Intestinal Tract in Type 2 Diabetes Patients and Healthy Controls. J Clin Endocrinol Metab. 2023 Nov 17;108(12):e1597-e1602. doi: 10.1210/clinem/dgad372.

  PMID: 37335970 DERIVED

• Gilliam-Vigh H, Jorsal T, Rehfeld JF, Pedersen J, Poulsen SS, Vilsboll T, Knop FK. Expression of Cholecystokinin and its Receptors in the Intestinal Tract of Type 2 Diabetes Patients and Healthy Controls. J Clin Endocrinol Metab. 2021 Jul 13;106(8):2164-2170. doi: 10.1210/clinem/dgab367.

  PMID: 34036343 DERIVED

• Jorsal T, Rhee NA, Pedersen J, Wahlgren CD, Mortensen B, Jepsen SL, Jelsing J, Dalboge LS, Vilmann P, Hassan H, Hendel JW, Poulsen SS, Holst JJ, Vilsboll T, Knop FK. Enteroendocrine K and L cells in healthy and type 2 diabetic individuals. Diabetologia. 2018 Feb;61(2):284-294. doi: 10.1007/s00125-017-4450-9. Epub 2017 Sep 28.

  PMID: 28956082 DERIVED

MeSH Terms

Interventions

Double-Balloon Enteroscopy

Intervention Hierarchy (Ancestors)

Balloon Enteroscopy; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, professor

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: February 7, 2017
• Study Start: March 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: February 15, 2017

Record last verified: 2017-02