ObesityMICIMABNCT02261831
Identify Bacteria Associated With Metabolic Diseases That Reside Both in Intestinal Crypts and in Blood
A study testing obese patients, diabetic patients and patients free of obesity and diabetes in people with Obesity, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The investigators will compare 16sRDNA profile in cases and controls in order to identify bacteria associated with metabolic diseases that reside both in intestinal crypts and in blood. Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- obese patients, diabetic patients and patients free of obesity and diabetes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Dec 2017
- 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 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between 35 and 75 years old
- Colonoscopy and biopsies required
- Diabetes population:
- Type 2 diabetes
- Obese population:
- Android obesity
Who cannot join
- Inflammatory bowel disease
- Colonic cancer
- Bariatric surgery
- Previous administration of antibiotic (within 15 days)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identify Bacteria Associated With Metabolic Diseases That Reside Both in Intestinal Crypts and in Blood.
The investigators will compare 16sRDNA profile in cases and controls in order to identify bacteria associated with metabolic diseases that reside both in intestinal crypts and in blood.
Read the detailed description
Experimental evidence suggests that bacterial translocation from gut to tissue could be an initial step leading to diabetes. To test this hypothesis, a bacterial component that is highly conserved between different species of bacteria, the 16S rDNA gene will be analysed both in intestinal crypt and in blood in patients with type 2 diabetes, obese patients and control.
- Conditions
- Obesity
- Being tested
- obese patients, diabetic patients, patients free of obesity and diabetes, patients free type 2 diabetes
- Keywords
- bacterial, gut, type 2 diabetes., 16S rDNA gene, intestinal crypt
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
obese patientsOther
collection of blood sampling and biopsies
diabetic patientsOther
collection of blood sampling and biopsies
patients free of obesity and diabetesOther
collection of blood sampling and biopsies
patients free type 2 diabetesOther
collection of blood sampling and biopsies
| Study group | Role | What they receive |
|---|---|---|
| obese patients | Experimental | Total blood sample, and 4 biopsies : collection of 2 colonic and 2 ileal biopsies Receives: Other: obese patients |
| Diabetic patients | Experimental | Total blood sample, and 4 biopsies : collection of 2 colonic and 2 ileal biopsies Receives: Other: diabetic patients |
| Patients free of obesity and diabetes | Experimental | Total blood sample, and 4 biopsies : collection of 2 colonic and 2 ileal biopsies Receives: Other: patients free of obesity and diabetes |
| patients free type 2 diabetes. | Experimental | Total blood sample, and 4 biopsies : collection of 2 colonic and 2 ileal biopsies Receives: Other: patients free type 2 diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
rDNA comparison between cases and controls
Comparison of 16sRDNA profile in cases and controls in order to identify bacteria associated with metabolic diseases that reside both in intestinal crypts and in blood.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques AMAR, MD PhD, Study director, University Hospital, ToulouseJacques Moreau, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02261831
- Sponsor's protocol ID
- 13 6936 03
- Acronym
- MICIMAB
- Status last verified
- Nov 2018
- First submitted
- 22 Jul 2014
- Last updated
- 3 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identify Bacteria Associated With Metabolic Diseases That Reside Both in Intestinal Crypts and in Blood.
- ClinicalTrials.gov ID
- NCT02261831
- Acronym / sponsor ID
- MICIMAB / 13 6936 03
- Conditions
- Obesity
- Keywords
- bacterial, gut, type 2 diabetes., 16S rDNA gene, intestinal crypt
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 10 Oct 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.
The investigators will compare 16sRDNA profile in cases and controls in order to identify bacteria associated with metabolic diseases that reside both in intestinal crypts and in blood.
Detailed description
Experimental evidence suggests that bacterial translocation from gut to tissue could be an initial step leading to diabetes. To test this hypothesis, a bacterial component that is highly conserved between different species of bacteria, the 16S rDNA gene will be analysed both in intestinal crypt and in blood in patients with type 2 diabetes, obese patients and control.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| obese patients | Experimental | Other: obese patientsTotal blood sample, and 4 biopsies : collection of 2 colonic and 2 ileal biopsies |
| Diabetic patients | Experimental | Other: diabetic patientsTotal blood sample, and 4 biopsies : collection of 2 colonic and 2 ileal biopsies |
| Patients free of obesity and diabetes | Experimental | Other: patients free of obesity and diabetesTotal blood sample, and 4 biopsies : collection of 2 colonic and 2 ileal biopsies |
| patients free type 2 diabetes. | Experimental | Other: patients free type 2 diabetesTotal blood sample, and 4 biopsies : collection of 2 colonic and 2 ileal biopsies |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Between 35 and 75 years old
- Colonoscopy and biopsies required
- Type 2 diabetes
- Android obesity
Key exclusion criteria (5 listed)
- Inflammatory bowel disease
- Colonic cancer
- Bariatric surgery
- Previous administration of antibiotic (within 15 days)
- Pregnancy
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 |
|---|---|---|
| obese patientscollection of blood sampling and biopsies | Other | obese patients |
| diabetic patientscollection of blood sampling and biopsies | Other | Diabetic patients |
| patients free of obesity and diabetescollection of blood sampling and biopsies | Other | Patients free of obesity and diabetes |
| patients free type 2 diabetescollection of blood sampling and biopsies | Other | patients free type 2 diabetes. |
Primary outcome
rDNA comparison between cases and controls
Time frame: 36 months
Comparison of 16sRDNA profile in cases and controls in order to identify bacteria associated with metabolic diseases that reside both in intestinal crypts and in blood.
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 3 Dec 2018.
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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.
Jacques AMAR, MD PhD study director
University Hospital, Toulouse
Jacques Moreau, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing obese patients, diabetic patients and patients free of obesity and diabetes in people with Obesity, run by University Hospital, Toulouse at 1 site in France.
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 6 inclusion and 5 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 3 Dec 2018. 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 France. 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?
rDNA comparison between cases and controls (time frame: 36 months). 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 3 Dec 2018; AzTrials last refreshed its copy on 6 Nov 2026.