Diabetes Mellitus Type 2Phase 4GLPNCT00473733
Glucagon Like Peptides Receptors Expression in the Stomach of Diabetes Type 2
A Phase 4 study testing GLP receptors expression and ESOPHAGOGASTRODUODENOSCOPY in people with Diabetes Mellitus Type 2, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Glucagon like peptides receptors expression in the stomach of diabetes type 2 Glucagon like peptides (GLP-1, GLP-2), are hormones secreted by L cells located along the gastrointestinal tract. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- GLP receptors expression and ESOPHAGOGASTRODUODENOSCOPY
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20 diabetes type 2 patients with symptoms that need upper endoscopy will be included in the study and 20 controls aged 18-70 years
Who cannot join
- Patients with neurological disease will be excluded
Trial locations and contacts
1 site in 1 country.
Israel1 site
Assaf Harofeh Medical Center
Tsrifin, 70300
eFRAT Broide, MD, 972-8-9779722, efibroide@yahoo.com
Efrat Broide, MD
About this study
Glucagon like peptides receptors expression in the stomach of diabetes type 2 Glucagon like peptides (GLP-1, GLP-2), are hormones secreted by L cells located along the gastrointestinal tract. These hormones are secreted after meals and have some roles in regulating the digestion process, absorption, and sending signals to the brain that regulate food consumption. GLP peptides affect peripheral targets and have an important homeostatic role. GLP-1 decreases the circulatory glucose level and GLP-2 has trophic effects which enable adequate intestine growth.
We aimed in our study to investigate the GLP-1 and GLP-2 receptor expression in different zones of the stomach in diabetes type 2 patients. If there are differences, it might explain the pathological gastric emptying in these patients.
Read more
Understanding the function of these peptides may lead to new therapeutic options for diabetic patients with delayed gastric emptying.
Methods: 20 diabetes type 2 patients with symptoms that need upper endoscopy will be included in the study and 20 controls aged 18-70 years. Patients with neurological disease will be excluded. During esophagogastroduodenoscopy 3 biopsies will be taken from the antrum, corpus and cardia. The biopsies will be stored in -70. After RNA extraction the GLP receptors expression will established by real time PCR method. Patients with different expression compared to control will undergo isotopic scan for gastric emptying.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- GLP receptors expression, ESOPHAGOGASTRODUODENOSCOPY
- Keywords
- PATIENTS WITH DIABETES MELLITUS TYPE 2, UNDERGO UPPER ENDOSCOPY, BIOPSIES FOR GLP RECEPTORS EXPRESSION, PCR ANALYSIS
- 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.
GLP receptors expressionProcedure or surgery
ESOPHAGOGASTRODUODENOSCOPYProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies 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 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Investigators
- Efrat Broide, MD, Principal investigator, Ethic committee of Asaaf Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00473733
- Sponsor's protocol ID
- 65/07
- Acronym
- GLP
- Status last verified
- Apr 2007
- First submitted
- 13 May 2007
- Last updated
- 15 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucagon Like Peptides Receptors Expression in the Stomach of Diabetes Type 2
- ClinicalTrials.gov ID
- NCT00473733
- Acronym / sponsor ID
- GLP / 65/07
- Conditions
- Diabetes Mellitus Type 2
- Keywords
- PATIENTS WITH DIABETES MELLITUS TYPE 2, UNDERGO UPPER ENDOSCOPY, BIOPSIES FOR GLP RECEPTORS EXPRESSION, PCR ANALYSIS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- First posted
- 15 May 2007 (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.
Glucagon like peptides receptors expression in the stomach of diabetes type 2 Glucagon like peptides (GLP-1, GLP-2), are hormones secreted by L cells located along the gastrointestinal tract. These hormones are secreted after meals and have some roles in regulating the digestion process, absorption, and sending signals to the brain that regulate food consumption. GLP peptides affect peripheral targets and have an important homeostatic role. GLP-1 decreases the circulatory glucose level and GLP-2 has trophic effects which enable adequate intestine growth.
We aimed in our study to investigate the GLP-1 and GLP-2 receptor expression in different zones of the stomach in diabetes type 2 patients. If there are differences, it might explain the pathological gastric emptying in these patients.
Understanding the function of these peptides may lead to new therapeutic options for diabetic patients with delayed gastric emptying.
Methods: 20 diabetes type 2 patients with symptoms that need upper endoscopy will be included in the study and 20 controls aged 18-70 years. Patients with neurological disease will be excluded. During esophagogastroduodenoscopy 3 biopsies will be taken from the antrum, corpus and cardia. The biopsies will be stored in -70. After RNA extraction the GLP receptors expression will established by real time PCR method. Patients with different expression compared to control will undergo isotopic scan for gastric emptying.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 20 diabetes type 2 patients with symptoms that need upper endoscopy will be included in the study and 20 controls aged 18-70 years
Key exclusion criteria (1 listed)
- Patients with neurological disease will be excluded
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 |
|---|---|---|
| GLP receptors expression | Procedure or surgery | – |
| ESOPHAGOGASTRODUODENOSCOPY | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2007.
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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.
Efrat Broide, MD principal investigator
Ethic committee of Asaaf Harofeh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing GLP receptors expression and ESOPHAGOGASTRODUODENOSCOPY in people with Diabetes Mellitus Type 2, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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 1 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: status not confirmed, as of the sponsor's last update on 15 May 2007. 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 Israel. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Efrat Broide, MD (972-8-9779722, efibroide@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 15 May 2007.