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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Role of Small Intestinal Endocrine Cells in Type 2 Diabetic Hyperglucagonemia

NCT00639613

Type 2 Diabetes

COMPLETED

The Role of Pregnancy-induced Gallbladder Dysmotility in the Pathophysiology of Gestational Diabetes Mellitus

NCT04108065

Gestational Diabetes Mellitus

COMPLETED

Importance of Meal Fat Content and Gall Bladder Emptying for Postprandial GLP-1 Secretion in Type 2 Diabetes Patients

NCT01374594

Diabetes

COMPLETED

Endogenous Glucoseproduction in Patients With Type 2 Diabetes Mellitus During Oral Glucose and iv. Glucose Infusion

NCT02010827

Type 2 Diabetes Mellitus

COMPLETED

Delineation of the Role of Glucagon-like Peptide-1 Signalling in Relation to Increased Carbohydrate Content in the Distal Small Intestines

NCT03241303

Glucose Metabolism Disorders

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type2 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Type 2 diabetes

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

Group Type EXPERIMENTAL

Double-balloon enteroscopy (DBE) with biopsy retrieval

Intervention Type 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

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

Group Type EXPERIMENTAL

Double-balloon enteroscopy (DBE) with biopsy retrieval

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes