Anatomical and Physiological Characteri… | Clinical Trial

Key information

Conditions

Type2 Diabetes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

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.
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.

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Registry information

Official study title

Enteroendocrine Cells in Healthy Individuals and Patients With Type 2 Diabetes

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Feb 7, 2017
Registry last updated: Feb 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed