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

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ClinicalTrials.gov Identifier: NCT03044860
Recruitment Status : Completed
First Posted : February 7, 2017
Last Update Posted : February 15, 2017
Sponsor:
Information provided by (Responsible Party):
Filip Krag Knop, 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.

Condition or disease Intervention/treatment Phase
Type2 Diabetes Procedure: Double-balloon enteroscopy (DBE) with biopsy retrieval Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Enteroendocrine Cells in Healthy Individuals and Patients With Type 2 Diabetes
Study Start Date : March 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: Type 2 diabetes
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
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

Experimental: Healthy
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
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




Primary Outcome Measures :
  1. Evaluation of enteroendocrine cells (density and mRNA expression) in the intestinal tract. [ Time Frame: 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.


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




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

Type 2 diabetes patients

  • Diagnosis of type 2 diabetes (at least 3 months prior to study inclusion)
  • 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

Exclusion criteria:

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
  • Allergy to soy protein or eggs
  • BMI >35 kg/m2 or any other condition that would contraindicate propofol sedation or enteroscopy
  • First-degree relative(s) with type 1 or type 2 diabetes.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Filip Krag Knop, MD, PhD, professor, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT03044860     History of Changes
Other Study ID Numbers: Endocrinemapping
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: February 15, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases