Intraluminal Imaging of Duodenal Layer Morphometry in Patients With and Without Type 2 Diabetes

An observational study of Type 2 Diabetes, run by Victoria Gomez at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This observational study is conducted to determine how the duodenal layer thicknesses (mucosa, submucosa, and muscularis) vary with several factors in patients with and without 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: Type 2 Diabetes
What is being tested?: EUS and OCT imaging
Type of treatment: Surgery or procedure
How many people: 21 participants
Where: 1 siteUnited States
Study dates: Mar 2016to Feb 2019
Phase: Observational
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

Study population: Patients undergoing previously scheduled routine endoscopy of the upper gastrointestinal tract.

Who may be able to join

Patient is already scheduled for upper endoscopy with ultrasound or OCT, such as those with Barrett's esophagus.
Patient is willing to sign an informed consent form.

Who cannot join

Patient is not a candidate for endoscopy, EUS, or OCT, such as those with strictures, inflammatory disease or previous anastomosis of the esophagus or duodenum.

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic in Florida
Jacksonville, Florida, 32224

Other trials in United States

About this study

Official title: A Single-center, Observational, Intraluminal Imaging Study of Duodenal Layer Morphometry in Patients With and Without Type 2 Diabetes Undergoing Endoscopy of the Upper Gastrointestinal Tract

This observational study is conducted to determine how the duodenal layer thicknesses (mucosa, submucosa, and muscularis) vary with several factors in patients with and without type 2 diabetes.

Read the detailed description

Study Objectives

To assess duodenal layer (mucosa, submucosa and muscularis) thickness differences between patients with and without type 2 diabetes using endoscopic ultrasound (EUS) and optical coherence tomography (OCT).
To assess duodenal layer thickness differences between patients with type 2 diabetes.
To assess duodenal layer thickness differences as a function of measurement location along the length of the duodenum.
To compare measurements obtained by endoscopic ultrasound, to those obtained by optical coherence tomography.

Conditions: Type 2 Diabetes
Being tested: EUS and OCT imaging
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EUS and OCT imagingProcedure or surgery
Intraluminal imaging using endoscopic ultrasound and endoscopic optical coherence tomography

Study groups in NCT02688920
Study group	Role	What they receive
With T2DM		Subjects with type 2 diabetes. Receives: Procedure: EUS and OCT imaging
Without T2DM		Subjects without type 2 diabetes Receives: Procedure: EUS and OCT imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

Thickness of the duodenal mucosa using OCT, and EUS if possible
Measured: During imaging

Secondary outcomes (1)

Thickness of the duodenal submucosa using OCT if possible, and EUS
Measured: During imaging

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2016Feb 2019

First posted23 Feb 2016 (estimated)
Study startMar 2016
Primary completionFeb 2019
Study completionFeb 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Type 2 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: Observational
Observational model: Case-control
Time perspective: Cross-sectional
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02688920
Sponsor's protocol ID: 15-007742
Status last verified: Mar 2019
First submitted: 18 Feb 2016
Last updated: 8 Mar 2019
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Buchwald H, Estok R, Fahrbach K, Banel D, Jensen MD, Pories WJ, Bantle JP, Sledge I. Weight and type 2 diabetes after bariatric surgery: systematic review and meta-analysis. Am J Med. 2009 Mar;122(3):248-256.e5. doi: 10.1016/j.amjmed.2008.09.041.
PubMed 19272486
Nagatake T, Fujita H, Minato N, Hamazaki Y. Enteroendocrine cells are specifically marked by cell surface expression of claudin-4 in mouse small intestine. PLoS One. 2014 Mar 6;9(6):e90638. doi: 10.1371/journal.pone.0090638. eCollection 2014.
PubMed 24603700
Haboubi NY, Lee GS, Montgomery RD. Duodenal mucosal morphometry of elderly patients with small intestinal bacterial overgrowth: response to antibiotic treatment. Age Ageing. 1991 Jan;20(1):29-32. doi: 10.1093/ageing/20.1.29.
PubMed 2028847
Maluenda C, Phillips AD, Briddon A, Walker-Smith JA. Quantitative analysis of small intestinal mucosa in cow's milk-sensitive enteropathy. J Pediatr Gastroenterol Nutr. 1984 Jun;3(3):349-56. doi: 10.1097/00005176-198406000-00008.
PubMed 6737178
Rosch T, Lorenz R, Zenker K, von Wichert A, Dancygier H, Hofler H, Siewert JR, Classen M. Local staging and assessment of resectability in carcinoma of the esophagus, stomach, and duodenum by endoscopic ultrasonography. Gastrointest Endosc. 1992 Jul-Aug;38(4):460-7. doi: 10.1016/s0016-5107(92)70477-5.
PubMed 1511822
Chang KJ, Katz KD, Durbin TE, Erickson RA, Butler JA, Lin F, Wuerker RB. Endoscopic ultrasound-guided fine-needle aspiration. Gastrointest Endosc. 1994 Nov-Dec;40(6):694-9.
PubMed 7859967
Sivak MV Jr, Kobayashi K, Izatt JA, Rollins AM, Ung-Runyawee R, Chak A, Wong RC, Isenberg GA, Willis J. High-resolution endoscopic imaging of the GI tract using optical coherence tomography. Gastrointest Endosc. 2000 Apr;51(4 Pt 1):474-9. doi: 10.1016/s0016-5107(00)70450-0.
PubMed 10744825
Gniuli D, Calcagno A, Dalla Libera L, Calvani R, Leccesi L, Caristo ME, Vettor R, Castagneto M, Ghirlanda G, Mingrone G. High-fat feeding stimulates endocrine, glucose-dependent insulinotropic polypeptide (GIP)-expressing cell hyperplasia in the duodenum of Wistar rats. Diabetologia. 2010 Oct;53(10):2233-40. doi: 10.1007/s00125-010-1830-9. Epub 2010 Jun 30.
PubMed 20585935

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-center, Observational, Intraluminal Imaging Study of Duodenal Layer Morphometry in Patients With and Without Type 2 Diabetes Undergoing Endoscopy of the Upper Gastrointestinal Tract
ClinicalTrials.gov ID: NCT02688920
Acronym / sponsor ID: 15-007742
Conditions: Type 2 Diabetes
Study type: Observational
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Victoria GomezUniversity, hospital or other
Study start: Mar 2016
Primary completion: Feb 2019 (actual)
Study completion: Feb 2019 (actual)
First posted: 23 Feb 2016 (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.

This observational study is conducted to determine how the duodenal layer thicknesses (mucosa, submucosa, and muscularis) vary with several factors in patients with and without type 2 diabetes.

Detailed description

Study Objectives

To assess duodenal layer (mucosa, submucosa and muscularis) thickness differences between patients with and without type 2 diabetes using endoscopic ultrasound (EUS) and optical coherence tomography (OCT).
To assess duodenal layer thickness differences between patients with type 2 diabetes.
To assess duodenal layer thickness differences as a function of measurement location along the length of the duodenum.
To compare measurements obtained by endoscopic ultrasound, to those obtained by optical coherence tomography.

Study design

Observational model: Case-control
Time perspective: Cross-sectional
Number of arms: 2

Arm	Type	Receives
With T2DM	–	Procedure: EUS and OCT imagingSubjects with type 2 diabetes.
Without T2DM	–	Procedure: EUS and OCT imagingSubjects without type 2 diabetes

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Patients undergoing previously scheduled routine endoscopy of the upper gastrointestinal tract.

Key inclusion criteria (2 listed)

Patient is already scheduled for upper endoscopy with ultrasound or OCT, such as those with Barrett's esophagus.
Patient is willing to sign an informed consent form.

Key exclusion criteria (1 listed)

Patient is not a candidate for endoscopy, EUS, or OCT, such as those with strictures, inflammatory disease or previous anastomosis of the esophagus or duodenum.

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
EUS and OCT imagingIntraluminal imaging using endoscopic ultrasound and endoscopic optical coherence tomography	Procedure or surgery	With T2DM, Without T2DM

Primary outcome

Thickness of the duodenal mucosa using OCT, and EUS if possible
Time frame: During imaging

1 secondary outcome

Thickness of the duodenal submucosa using OCT if possible, and EUS
Time frame: During imaging

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 8 Mar 2019.
Background: PubMed 19272486Buchwald H, Estok R, Fahrbach K, Banel D, Jensen MD, Pories WJ, Bantle JP, Sledge I. Weight and type 2 diabetes after bariatric surgery: systematic review and meta-analysis. Am J Med. 2009 Mar;122(3):248-256.e5. doi: 10.1016/j.amjmed.2008.09.041.
Background: PubMed 24603700Nagatake T, Fujita H, Minato N, Hamazaki Y. Enteroendocrine cells are specifically marked by cell surface expression of claudin-4 in mouse small intestine. PLoS One. 2014 Mar 6;9(6):e90638. doi: 10.1371/journal.pone.0090638. eCollection 2014.
Background: PubMed 2028847Haboubi NY, Lee GS, Montgomery RD. Duodenal mucosal morphometry of elderly patients with small intestinal bacterial overgrowth: response to antibiotic treatment. Age Ageing. 1991 Jan;20(1):29-32. doi: 10.1093/ageing/20.1.29.
Background: PubMed 6737178Maluenda C, Phillips AD, Briddon A, Walker-Smith JA. Quantitative analysis of small intestinal mucosa in cow's milk-sensitive enteropathy. J Pediatr Gastroenterol Nutr. 1984 Jun;3(3):349-56. doi: 10.1097/00005176-198406000-00008.
Background: PubMed 1511822Rosch T, Lorenz R, Zenker K, von Wichert A, Dancygier H, Hofler H, Siewert JR, Classen M. Local staging and assessment of resectability in carcinoma of the esophagus, stomach, and duodenum by endoscopic ultrasonography. Gastrointest Endosc. 1992 Jul-Aug;38(4):460-7. doi: 10.1016/s0016-5107(92)70477-5.
Background: PubMed 7859967Chang KJ, Katz KD, Durbin TE, Erickson RA, Butler JA, Lin F, Wuerker RB. Endoscopic ultrasound-guided fine-needle aspiration. Gastrointest Endosc. 1994 Nov-Dec;40(6):694-9.
Background: PubMed 10744825Sivak MV Jr, Kobayashi K, Izatt JA, Rollins AM, Ung-Runyawee R, Chak A, Wong RC, Isenberg GA, Willis J. High-resolution endoscopic imaging of the GI tract using optical coherence tomography. Gastrointest Endosc. 2000 Apr;51(4 Pt 1):474-9. doi: 10.1016/s0016-5107(00)70450-0.
Background: PubMed 20585935Gniuli D, Calcagno A, Dalla Libera L, Calvani R, Leccesi L, Caristo ME, Vettor R, Castagneto M, Ghirlanda G, Mingrone G. High-fat feeding stimulates endocrine, glucose-dependent insulinotropic polypeptide (GIP)-expressing cell hyperplasia in the duodenum of Wistar rats. Diabetologia. 2010 Oct;53(10):2233-40. doi: 10.1007/s00125-010-1830-9. Epub 2010 Jun 30.
Individual participant dataSharing planned: No

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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.

Victoria Gomez, MD principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes, run by Victoria Gomez at 1 site in United States.

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 2 inclusion and 1 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 8 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Thickness of the duodenal mucosa using OCT, and EUS if possible (time frame: During imaging). 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 NCT02688920, which also lists 8 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 8 Mar 2019.