Type2 DiabetesNCT03044860
Anatomical and Physiological Characterisation of the Gut Endocrine Cells in Healthy and in Patients With Type 2 Diabetes
A study testing Double-balloon enteroscopy (DBE) with biopsy retrieval in people with Type2 Diabetes, run by University Hospital, Gentofte, Copenhagen.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- Double-balloon enteroscopy (DBE) with biopsy retrieval
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
About this study
Official title: Enteroendocrine Cells in Healthy Individuals and Patients With Type 2 Diabetes
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.
Read the 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.
- Conditions
- Type2 Diabetes
- Being tested
- Double-balloon enteroscopy (DBE) with biopsy retrieval
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double-balloon enteroscopy (DBE) with biopsy retrievalProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetes | Experimental | Adult patients with type 2 diabetes undergoing double-balloon enteroscopy (DBE) with biopsy retrieval using a DBE-device. Receives: 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. Receives: Procedure: Double-balloon enteroscopy (DBE) with biopsy retrieval |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Cross-sectional study. Each participant went through two study days (upper and lower double-ballon enteroscopy, respectively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study startMar 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filip Krag Knop, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03044860
- Sponsor's protocol ID
- Endocrinemapping
- Status last verified
- Feb 2017
- First submitted
- 10 Jan 2017
- Last updated
- 15 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 40803750Gilliam-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.
PubMed 40004948Gilliam-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.
PubMed 37335970Gilliam-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.
PubMed 34036343Jorsal 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.
PubMed 28956082
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enteroendocrine Cells in Healthy Individuals and Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03044860
- Acronym / sponsor ID
- Endocrinemapping
- Conditions
- Type2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 7 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetes | Experimental | Procedure: Double-balloon enteroscopy (DBE) with biopsy retrievalAdult patients with type 2 diabetes undergoing double-balloon enteroscopy (DBE) with biopsy retrieval using a DBE-device. |
| Healthy | Experimental | Procedure: Double-balloon enteroscopy (DBE) with biopsy retrievalAdult subjects without type 2 diabetes undergoing double-balloon enteroscopy (DBE) with biopsy retrieval using a DBE-device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Double-balloon enteroscopy (DBE) with biopsy retrievalWith 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 | Procedure or surgery | Healthy, Type 2 diabetes |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
- Derived from this study: PubMed 40803750Gilliam-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.
- Derived from this study: PubMed 40004948Gilliam-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.
- Derived from this study: PubMed 37335970Gilliam-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.
- Derived from this study: PubMed 34036343Gilliam-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.
- Derived from this study: PubMed 28956082Jorsal 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Double-balloon enteroscopy (DBE) with biopsy retrieval in people with Type2 Diabetes, run by University Hospital, Gentofte, Copenhagen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03044860, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2017.