Distribution of Nutrient Receptors Studied in Intestinal Tissue Obtained Via EndoscopyNCT02051881
Identification of Nutrient Receptors Gastrointestinal Tract
A study testing Taking intestinal biopsies in people with Distribution of Nutrient Receptors Studied in Intestinal Tissue Obtained Via Endoscopy, run by Maastricht University Medical Center.
Trial summary
Investigating which receptors are involved in nutient sensing of enteroendocrine cells and on nerve endings, gives further knowledge on the kind of nutrients responsible for the secretion of gut hormones involved in satiety signalling. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Distribution of Nutrient Receptors Studied in Intestinal Tissue Obtained Via Endoscopy
- What is being tested?
- Taking intestinal biopsies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- May 2012to Jun 2013
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Step 1 (patients asked for participation):
- Patients (male and female between 18 and 65 years) referred for upper GI endoscopy (because of functional complaints)
- Based on medical history and previous examination, no objection arises for taking extra biopsies during the gastroduodenoscopy.
- Step 2 (patients agreed to participate and in whom biopsies will be taken) 1) Patients with no relevant endoscopic abnormalities (gastroduodenoscopy): patients without gastric or duodenal ulcers/polyps/lesions suspect for malignancy and esophageal lesions or varices.
- Step 1 (patients asked for participation):
- Patients (male and female between 18 and 65 years) referred for colonoscopy (because of screening for colorectal cancer or follow up of colonic polyps) Based on medical history and previous examination, no objection arises for taking extra biopsies during the colonoscopy
- Step 2 (patients agreed to participate and in whom biopsies will be taken) Patients with no relevant endoscopic abnormalities (colonoscopy): patients without ileal and/or colonic ulcers/polyps/diverticula and lesions suspect for malignancy Ileum can be reached during colonoscopy
Who cannot join
- History of severe cardiovascular, gastrointestinal/ hepatic, hematological/immunologic, metabolic/nutritional disease and/or laboratory assessments which might limit participation in the study. The severity of the disease (major interference with the execution of the experiment or potential influence on the study outcomes) will be decided by the principal investigator.
- Use of medication, which could interfere with normal coagulation (anticoagulants, antiplatelet drugs).
- Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon judgement of the principle investigator)
- Excessive alcohol consumption (>20 alcoholic consumptions per week)
About this study
Official title: The Identification and Spatial Distribution of Different Nutrient Receptors Along the Gastrointestinal (GI) Tract
Investigating which receptors are involved in nutient sensing of enteroendocrine cells and on nerve endings, gives further knowledge on the kind of nutrients responsible for the secretion of gut hormones involved in satiety signalling. So far only little is know about the distribution of potential nutient sensing receptors along the gastrointestinal tract. The investigators are interested in the intestinal parts which highly secrete CCK and GLP-1. By comparing these tissues, it is expected to further elucidate which receptors are important for satiety signalling in the intestine.
Having this information gives rise to further reseach on how these receptors stimulate the secretion of gut hormones. Moreover, knowing which receptors are involved in satiety signalling, gives oppertunity for targeting these receptors to increase satiety and influencing food intake.
The investigators aim to investigate the distribution of the above mentioned receptors, in the following referred to as 'nutrient sensing receptors', which have been suggested to be involved in satiety signalling, throughout the intestinal tract. For these receptors the gene expression, localisation and protein expression will be determined at different locations. This will be measured in intestinal mucosal biopsies of two locations in the duodenum, in the terminal ileum, the ascending colon, the transverse colon and the descending colon.
- Being tested
- Taking intestinal biopsies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taking intestinal biopsiesOther
| Study group | Role | What they receive |
|---|---|---|
| Biopsies | Other | Intestinal biopsies were taken in patients who underwent endoscopy. Receives: Other: Taking intestinal biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurements of the expression of receptors with quantitative reverse transcription polymerase chain reaction (q-PCR) in mucosal biopsies of the duodenum, terminal ileum and colon.
Measurements of the expression of receptors with quantitative reverse transcription polymerase chain reaction (q-PCR) in mucosal biopsies of the duodenum, terminal ileum and colon.
Measured: 1 day
Secondary outcomes (2)
Measurements of the location of the receptors with immunohistological techniques in mucosal biopsies of the duodenum, terminal ileum and colon.
Measurements of the location of the receptors with immunohistological techniques in mucosal biopsies of the duodenum, terminal ileum and colon.
Measured: 1 day
Measurements of protein expression in mucosal biopsies of the duodenum, terminal ileum and colon.
Measurements of protein expression in mucosal biopsies of the duodenum, terminal ileum and colon.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startMay 2012
- Primary completionMar 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distribution of Nutrient Receptors Studied in Intestinal Tissue Obtained Via EndoscopyStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prof Masclee, MD,PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02051881
- Sponsor's protocol ID
- NL39168.068.12
- Status last verified
- Jan 2014
- First submitted
- 30 Jan 2014
- Last updated
- 31 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Identification and Spatial Distribution of Different Nutrient Receptors Along the Gastrointestinal (GI) Tract
- ClinicalTrials.gov ID
- NCT02051881
- Acronym / sponsor ID
- NL39168.068.12
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 31 Jan 2014 (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.
Investigating which receptors are involved in nutient sensing of enteroendocrine cells and on nerve endings, gives further knowledge on the kind of nutrients responsible for the secretion of gut hormones involved in satiety signalling. So far only little is know about the distribution of potential nutient sensing receptors along the gastrointestinal tract. The investigators are interested in the intestinal parts which highly secrete CCK and GLP-1. By comparing these tissues, it is expected to further elucidate which receptors are important for satiety signalling in the intestine.
Having this information gives rise to further reseach on how these receptors stimulate the secretion of gut hormones. Moreover, knowing which receptors are involved in satiety signalling, gives oppertunity for targeting these receptors to increase satiety and influencing food intake.
The investigators aim to investigate the distribution of the above mentioned receptors, in the following referred to as 'nutrient sensing receptors', which have been suggested to be involved in satiety signalling, throughout the intestinal tract. For these receptors the gene expression, localisation and protein expression will be determined at different locations. This will be measured in intestinal mucosal biopsies of two locations in the duodenum, in the terminal ileum, the ascending colon, the transverse colon and the descending colon.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biopsies | Other | Other: Taking intestinal biopsiesIntestinal biopsies were taken in patients who underwent endoscopy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Step 1 (patients asked for participation):
- Step 2 (patients agreed to participate and in whom biopsies will be taken) 1) Patients with no relevant endoscopic abnormalities (gastroduodenoscopy): patients without gastric or duodenal ulcers/polyps/lesions suspect for malignancy and esophageal lesions or varices.
- Step 1 (patients asked for participation):
- Patients (male and female between 18 and 65 years) referred for colonoscopy (because of screening for colorectal cancer or follow up of colonic polyps) Based on medical history and previous examination, no objection arises for taking extra biopsies during the colonoscopy
- Step 2 (patients agreed to participate and in whom biopsies will be taken) Patients with no relevant endoscopic abnormalities (colonoscopy): patients without ileal and/or colonic ulcers/polyps/diverticula and lesions suspect for malignancy Ileum can be reached during colonoscopy
Key exclusion criteria (4 listed)
- History of severe cardiovascular, gastrointestinal/ hepatic, hematological/immunologic, metabolic/nutritional disease and/or laboratory assessments which might limit participation in the study. The severity of the disease (major interference with the execution of the experiment or potential influence on the study outcomes) will be decided by the principal investigator.
- Use of medication, which could interfere with normal coagulation (anticoagulants, antiplatelet drugs).
- Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon judgement of the principle investigator)
- Excessive alcohol consumption (>20 alcoholic consumptions per week)
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 |
|---|---|---|
| Taking intestinal biopsies | Other | Biopsies |
Primary outcome
Measurements of the expression of receptors with quantitative reverse transcription polymerase chain reaction (q-PCR) in mucosal biopsies of the duodenum, terminal ileum and colon.
Time frame: 1 day
Measurements of the expression of receptors with quantitative reverse transcription polymerase chain reaction (q-PCR) in mucosal biopsies of the duodenum, terminal ileum and colon.
2 secondary outcomes
Measurements of the location of the receptors with immunohistological techniques in mucosal biopsies of the duodenum, terminal ileum and colon.
Time frame: 1 day
Measurements of protein expression in mucosal biopsies of the duodenum, terminal ileum and colon.
Time frame: 1 day
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 31 Jan 2014.
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.
Prof Masclee, MD,PhD principal investigator
Maastricht University Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Taking intestinal biopsies in people with Distribution of Nutrient Receptors Studied in Intestinal Tissue Obtained Via Endoscopy, run by Maastricht University Medical Center.
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 7 inclusion and 4 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 31 Jan 2014. 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?
Measurements of the expression of receptors with quantitative reverse transcription polymerase chain reaction (q-PCR) in mucosal biopsies of the duodenum, terminal ileum and colon. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2014.