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

University Hospital, Gentofte, Copenhagen

Status

Completed

Conditions

Type2 Diabetes

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03044860

Endocrinemapping

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.