Inflammatory Bowel DiseasesDiagMICINCT05196958
Interest of GLP1 Analogues in Overweight Type 2 Diabetic Patients With Chronic Inflammatory Bowel Disease
A study testing GLP1 analogues in people with Inflammatory Bowel Diseases and Diabetes Mellitus, Type 2, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
The risk of type 2 diabetes appears to be higher in patients with chronic inflammatory diseases, including chronic inflammatory bowel disease (IBD). IBD is a group of inflammatory diseases that includes mainly Crohn's disease and ulcerative colitis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Diabetes Mellitus, Type 2
- What is being tested?
- GLP1 analogues
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jan 2022to 31 Dec 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patient with a personal or family history of medullary thyroid cancer
- Patient with an active cancer
- Patient with a history of acute or chronic pancreatitis
- Patients with a history of hypersensitivity to GLP1 analogues (or to any other component of the product)
- Patient with a history of severe GI intolerance to GLP-1 receptor agonists
- Patient already included in a risky interventional research protocol (RIPH1)
Show all 14Show fewer
- Pregnant or breastfeeding women
- Patients with congestive heart failure New York Heart Association (NYHA) class IV
- Patient with end-stage renal disease
- Patients with clinically significant sustained elevation of resting heart rate
- Patient with anti-GAD antibodies in a previous workup at inclusion
- Patient under guardianship or curatorship
- Patient under court protection
- Patient deprived of liberty
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Groupe Hospitalier Paris Saint-Joseph
Paris, 75014
Helene BEAUSSIER, PharmD, PhD, 144127883 ext. +33, crc@ghpsj.fr
About this study
Official title: Interest of GLP1 Analogues (aGLP1) in Overweight Type 2 Diabetic Patients With Chronic Inflammatory Bowel Disease (IBD)
The risk of type 2 diabetes appears to be higher in patients with chronic inflammatory diseases, including chronic inflammatory bowel disease (IBD). IBD is a group of inflammatory diseases that includes mainly Crohn's disease and ulcerative colitis.
Although the majority of IBD patients are not overweight, the prevalence of obesity in this population remains significant, estimated at 15 to 40%. It has been shown that obesity can impact the response to therapies used in IBD as well as the clinical course of the disease:
Read more
- plasma concentrations of immunomodulatory therapies are often lower in the obese compared to those with a normal Body Mass Index (BMI) with a lower dose per kg of the administered drug as well as an acceleration of drug clearance.
2nd) Surgical management of IBD is associated with a higher risk of peri- and post-operative complications in obese patients, including an increase in operating time, bleeding risk, length of hospital stay and percentage of post-operative infections.
3e) Finally, obesity seems to have a negative impact on the clinical course of IBD, with a correlation between an increase in BMI and an increase in the number of hospitalizations, the number of follow-up consultations and the need for therapeutic escalation.
One of the common pathophysiological explanations between IBD and metabolic syndrome (including type 2 diabetes and obesity), would involve metabolites in the gut that are modulated by the gut microbiota.
Glucagon-Like Peptide 1 (aGLP1) analogues are a new class of injectable antidiabetic drugs that have revolutionized the management of type 2 diabetes. They include exenatide, lixisenatide, liraglutide, dulaglutide and semaglutide. They combine an effect on glycemic control but also usually a weight loss. In some countries, they are used in non-diabetic obese patients, with a weight loss of up to -10 to -15%. These molecules bind to GLP1 receptors, stimulate insulin secretion when blood glucose levels are high, decrease glucagon secretion, slow gastric emptying and stimulate satiety. In addition to glycemic control, weight reduction is most often associated.
In addition, some aGLP1s have been shown to reduce cardiovascular events in diabetics. They are well tolerated, but their side effects are mainly digestive, such as nausea, vomiting and sometimes diarrhea. These problems occur in about 20% of cases, most often after the first injection, with vomiting requiring permanent cessation of treatment. Most often they gradually subside, spontaneously or after symptomatic treatment, and allow titration of the drug.
Due to the lack of studies and possible intestinal effects, aGLP1 is not recommended in cases of severe gastrointestinal disease, and therefore in cases of IBD, although it is not contraindicated.
The main objective of this study is to test the interest of these GLP1 analogues in type 2 diabetics with IBD, who are overweight and whose glycemic target is not reached. The expected benefit is to facilitate diabetes control and weight loss in this population. The second objective is to monitor the occurrence of adverse events in this population with the different GLP1 analogues used.
- Being tested
- GLP1 analogues
- Medical subject headings
- Inflammatory Bowel Diseases, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP1 analoguesOther
This cohort study has 2 phases: an observation phase to collect all initial clinical and biological parameters and an intervention phase (prescription of GLP1 analogues) of 6 months including a visit at 3 and 6 months.
| Study group | Role | What they receive |
|---|---|---|
| GLP1 analogues | Experimental | This cohort study has 2 phases: an observation phase to collect all initial clinical and biological parameters and an intervention phase (prescription of GLP1 analogues) of 6 months including a visit at 3 and 6 months. Receives: Other: GLP1 analogues |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control
This outcome corresponds to the Change in HbA1c at 3 and 6 months compared with baseline at initiation of therapy.
Measured: Month 6
Weight loss
This outcome corresponds to the weight reducation at 3 and 6 months compared to baseline.
Measured: Month 6
Secondary outcomes (5)
Tolerance of GLP1 analogues after 3 months of treatment
This outcome corresponds to th number of serious and non-serious adverse events after 3 months of treatment with aGLP1.
Measured: Month 3
Tolerance of GLP1 analogues after 6 months of treatment tolerance of GLP1 analogues after 3 and 6 months of treatment
This outcome corresponds to the number of serious and non-serious adverse events after 6 months of treatment with aGLP1.
Measured: Month 6
Quality of life after 3 months of treatment
This outcome corresponds to the Quality of life of patients according to the Inflammatory Bowel Disease Questionnaire score. It includes 32 items in four domains: digestive symptoms (10 items), systemic symptoms (5 items), emotional disorders (12 items), social function (5 items). Each item is measured using the Likert technique. For each item, the interviewer presents a set of 7 statements describing an attitude. To each degree of agreement, a numerical value (from 1 to 7) is attached. In this way, by adding the individual scores, a total numerical value can be calculated. The total score ranges from 32 to 224, the higher the score the better the quality of life. This index has been validated and is correlated with the different disease activity scores.
Measured: Month 3
Quality of life after 6 months of treatment
This outcome corresponds to the Quality of life of patients according to the Inflammatory Bowel Disease Questionnaire score. It includes 32 items in four domains: digestive symptoms (10 items), systemic symptoms (5 items), emotional disorders (12 items), social function (5 items). Each item is measured using the Likert technique. For each item, the interviewer presents a set of 7 statements describing an attitude. To each degree of agreement, a numerical value (from 1 to 7) is attached. In this way, by adding the individual scores, a total numerical value can be calculated. The total score ranges from 32 to 224, the higher the score the better the quality of life. This index has been validated and is correlated with the different disease activity scores.
Measured: Month 6
Impact of aGLP1 on the treatment already in place to regulate blood glucose
This outcome corresponds to the reduction in number/dose of anti-diabetic medications or daily insulin dose.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start25 Jan 2022
- Primary completion14 Jan 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adela VOICAN, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196958
- Sponsor's protocol ID
- DiagMICI
- Acronym
- DiagMICI
- Status last verified
- Mar 2023
- First submitted
- 30 Dec 2021
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dregan A, Charlton J, Chowienczyk P, Gulliford MC. Chronic inflammatory disorders and risk of type 2 diabetes mellitus, coronary heart disease, and stroke: a population-based cohort study. Circulation. 2014 Sep 2;130(10):837-44. doi: 10.1161/CIRCULATIONAHA.114.009990. Epub 2014 Jun 26.
PubMed 24970784Jess T, Jensen BW, Andersson M, Villumsen M, Allin KH. Inflammatory Bowel Diseases Increase Risk of Type 2 Diabetes in a Nationwide Cohort Study. Clin Gastroenterol Hepatol. 2020 Apr;18(4):881-888.e1. doi: 10.1016/j.cgh.2019.07.052. Epub 2019 Aug 5.
PubMed 31394285Singh S, Dulai PS, Zarrinpar A, Ramamoorthy S, Sandborn WJ. Obesity in IBD: epidemiology, pathogenesis, disease course and treatment outcomes. Nat Rev Gastroenterol Hepatol. 2017 Feb;14(2):110-121. doi: 10.1038/nrgastro.2016.181. Epub 2016 Nov 30.
PubMed 27899815Seminerio JL, Koutroubakis IE, Ramos-Rivers C, Hashash JG, Dudekula A, Regueiro M, Baidoo L, Barrie A, Swoger J, Schwartz M, Weyant K, Dunn MA, Binion DG. Impact of Obesity on the Management and Clinical Course of Patients with Inflammatory Bowel Disease. Inflamm Bowel Dis. 2015 Dec;21(12):2857-63. doi: 10.1097/MIB.0000000000000560.
PubMed 26241001Hicks G, Abdulaal A, Slesser AAP, Mohsen Y. Outcomes of inflammatory bowel disease surgery in obese versus non-obese patients: a meta-analysis. Tech Coloproctol. 2019 Oct;23(10):947-955. doi: 10.1007/s10151-019-02080-0. Epub 2019 Sep 17.
PubMed 31531732Pavelock N, Masood U, Minchenberg S, Heisig D. Effects of obesity on the course of inflammatory bowel disease. Proc (Bayl Univ Med Cent). 2019 Feb 1;32(1):14-17. doi: 10.1080/08998280.2018.1542887. eCollection 2019 Jan.
PubMed 30956572Verdugo-Meza A, Ye J, Dadlani H, Ghosh S, Gibson DL. Connecting the Dots Between Inflammatory Bowel Disease and Metabolic Syndrome: A Focus on Gut-Derived Metabolites. Nutrients. 2020 May 15;12(5):1434. doi: 10.3390/nu12051434.
PubMed 32429195Nauck M, Frid A, Hermansen K, Shah NS, Tankova T, Mitha IH, Zdravkovic M, During M, Matthews DR; LEAD-2 Study Group. Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in type 2 diabetes: the LEAD (liraglutide effect and action in diabetes)-2 study. Diabetes Care. 2009 Jan;32(1):84-90. doi: 10.2337/dc08-1355. Epub 2008 Oct 17.
PubMed 18931095O'Neil PM, Birkenfeld AL, McGowan B, Mosenzon O, Pedersen SD, Wharton S, Carson CG, Jepsen CH, Kabisch M, Wilding JPH. Efficacy and safety of semaglutide compared with liraglutide and placebo for weight loss in patients with obesity: a randomised, double-blind, placebo and active controlled, dose-ranging, phase 2 trial. Lancet. 2018 Aug 25;392(10148):637-649. doi: 10.1016/S0140-6736(18)31773-2. Epub 2018 Aug 16.
PubMed 30122305Astrup A, Rossner S, Van Gaal L, Rissanen A, Niskanen L, Al Hakim M, Madsen J, Rasmussen MF, Lean ME; NN8022-1807 Study Group. Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study. Lancet. 2009 Nov 7;374(9701):1606-16. doi: 10.1016/S0140-6736(09)61375-1. Epub 2009 Oct 23.
PubMed 19853906Zatorski H, Salaga M, Fichna J. Role of glucagon-like peptides in inflammatory bowel diseases-current knowledge and future perspectives. Naunyn Schmiedebergs Arch Pharmacol. 2019 Nov;392(11):1321-1330. doi: 10.1007/s00210-019-01698-z. Epub 2019 Jul 29.
PubMed 31359088
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of GLP1 Analogues (aGLP1) in Overweight Type 2 Diabetic Patients With Chronic Inflammatory Bowel Disease (IBD)
- ClinicalTrials.gov ID
- NCT05196958
- Acronym / sponsor ID
- DiagMICI / DiagMICI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 14 Jan 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 Jan 2022 (actual)
- 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 risk of type 2 diabetes appears to be higher in patients with chronic inflammatory diseases, including chronic inflammatory bowel disease (IBD). IBD is a group of inflammatory diseases that includes mainly Crohn's disease and ulcerative colitis.
Although the majority of IBD patients are not overweight, the prevalence of obesity in this population remains significant, estimated at 15 to 40%. It has been shown that obesity can impact the response to therapies used in IBD as well as the clinical course of the disease:
- plasma concentrations of immunomodulatory therapies are often lower in the obese compared to those with a normal Body Mass Index (BMI) with a lower dose per kg of the administered drug as well as an acceleration of drug clearance.
2nd) Surgical management of IBD is associated with a higher risk of peri- and post-operative complications in obese patients, including an increase in operating time, bleeding risk, length of hospital stay and percentage of post-operative infections.
3e) Finally, obesity seems to have a negative impact on the clinical course of IBD, with a correlation between an increase in BMI and an increase in the number of hospitalizations, the number of follow-up consultations and the need for therapeutic escalation.
One of the common pathophysiological explanations between IBD and metabolic syndrome (including type 2 diabetes and obesity), would involve metabolites in the gut that are modulated by the gut microbiota.
Glucagon-Like Peptide 1 (aGLP1) analogues are a new class of injectable antidiabetic drugs that have revolutionized the management of type 2 diabetes. They include exenatide, lixisenatide, liraglutide, dulaglutide and semaglutide. They combine an effect on glycemic control but also usually a weight loss. In some countries, they are used in non-diabetic obese patients, with a weight loss of up to -10 to -15%. These molecules bind to GLP1 receptors, stimulate insulin secretion when blood glucose levels are high, decrease glucagon secretion, slow gastric emptying and stimulate satiety. In addition to glycemic control, weight reduction is most often associated.
In addition, some aGLP1s have been shown to reduce cardiovascular events in diabetics. They are well tolerated, but their side effects are mainly digestive, such as nausea, vomiting and sometimes diarrhea. These problems occur in about 20% of cases, most often after the first injection, with vomiting requiring permanent cessation of treatment. Most often they gradually subside, spontaneously or after symptomatic treatment, and allow titration of the drug.
Due to the lack of studies and possible intestinal effects, aGLP1 is not recommended in cases of severe gastrointestinal disease, and therefore in cases of IBD, although it is not contraindicated.
The main objective of this study is to test the interest of these GLP1 analogues in type 2 diabetics with IBD, who are overweight and whose glycemic target is not reached. The expected benefit is to facilitate diabetes control and weight loss in this population. The second objective is to monitor the occurrence of adverse events in this population with the different GLP1 analogues used.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GLP1 analogues | Experimental | Other: GLP1 analoguesThis cohort study has 2 phases: an observation phase to collect all initial clinical and biological parameters and an intervention phase (prescription of GLP1 analogues) of 6 months including a visit at 3 and 6 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (14 listed)
- Patient with a personal or family history of medullary thyroid cancer
- Patient with an active cancer
- Patient with a history of acute or chronic pancreatitis
- Patients with a history of hypersensitivity to GLP1 analogues (or to any other component of the product)
- Patient with a history of severe GI intolerance to GLP-1 receptor agonists
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 |
|---|---|---|
| GLP1 analoguesThis cohort study has 2 phases: an observation phase to collect all initial clinical and biological parameters and an intervention phase (prescription of GLP1 analogues) of 6 months including a visit at 3 and 6 months. | Other | GLP1 analogues |
Primary outcome
Glycemic control
Time frame: Month 6
This outcome corresponds to the Change in HbA1c at 3 and 6 months compared with baseline at initiation of therapy.
Weight loss
Time frame: Month 6
This outcome corresponds to the weight reducation at 3 and 6 months compared to baseline.
5 secondary outcomes
Tolerance of GLP1 analogues after 3 months of treatment
Time frame: Month 3
Tolerance of GLP1 analogues after 6 months of treatment tolerance of GLP1 analogues after 3 and 6 months of treatment
Time frame: Month 6
Quality of life after 3 months of treatment
Time frame: Month 3
Quality of life after 6 months of treatment
Time frame: Month 6
Impact of aGLP1 on the treatment already in place to regulate blood glucose
Time frame: Month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Background: PubMed 24970784Dregan A, Charlton J, Chowienczyk P, Gulliford MC. Chronic inflammatory disorders and risk of type 2 diabetes mellitus, coronary heart disease, and stroke: a population-based cohort study. Circulation. 2014 Sep 2;130(10):837-44. doi: 10.1161/CIRCULATIONAHA.114.009990. Epub 2014 Jun 26.
- Background: PubMed 31394285Jess T, Jensen BW, Andersson M, Villumsen M, Allin KH. Inflammatory Bowel Diseases Increase Risk of Type 2 Diabetes in a Nationwide Cohort Study. Clin Gastroenterol Hepatol. 2020 Apr;18(4):881-888.e1. doi: 10.1016/j.cgh.2019.07.052. Epub 2019 Aug 5.
- Background: PubMed 27899815Singh S, Dulai PS, Zarrinpar A, Ramamoorthy S, Sandborn WJ. Obesity in IBD: epidemiology, pathogenesis, disease course and treatment outcomes. Nat Rev Gastroenterol Hepatol. 2017 Feb;14(2):110-121. doi: 10.1038/nrgastro.2016.181. Epub 2016 Nov 30.
- Background: PubMed 26241001Seminerio JL, Koutroubakis IE, Ramos-Rivers C, Hashash JG, Dudekula A, Regueiro M, Baidoo L, Barrie A, Swoger J, Schwartz M, Weyant K, Dunn MA, Binion DG. Impact of Obesity on the Management and Clinical Course of Patients with Inflammatory Bowel Disease. Inflamm Bowel Dis. 2015 Dec;21(12):2857-63. doi: 10.1097/MIB.0000000000000560.
- Background: PubMed 31531732Hicks G, Abdulaal A, Slesser AAP, Mohsen Y. Outcomes of inflammatory bowel disease surgery in obese versus non-obese patients: a meta-analysis. Tech Coloproctol. 2019 Oct;23(10):947-955. doi: 10.1007/s10151-019-02080-0. Epub 2019 Sep 17.
- Background: PubMed 30956572Pavelock N, Masood U, Minchenberg S, Heisig D. Effects of obesity on the course of inflammatory bowel disease. Proc (Bayl Univ Med Cent). 2019 Feb 1;32(1):14-17. doi: 10.1080/08998280.2018.1542887. eCollection 2019 Jan.
- Background: PubMed 32429195Verdugo-Meza A, Ye J, Dadlani H, Ghosh S, Gibson DL. Connecting the Dots Between Inflammatory Bowel Disease and Metabolic Syndrome: A Focus on Gut-Derived Metabolites. Nutrients. 2020 May 15;12(5):1434. doi: 10.3390/nu12051434.
- Background: PubMed 18931095Nauck M, Frid A, Hermansen K, Shah NS, Tankova T, Mitha IH, Zdravkovic M, During M, Matthews DR; LEAD-2 Study Group. Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in type 2 diabetes: the LEAD (liraglutide effect and action in diabetes)-2 study. Diabetes Care. 2009 Jan;32(1):84-90. doi: 10.2337/dc08-1355. Epub 2008 Oct 17.
- Background: PubMed 30122305O'Neil PM, Birkenfeld AL, McGowan B, Mosenzon O, Pedersen SD, Wharton S, Carson CG, Jepsen CH, Kabisch M, Wilding JPH. Efficacy and safety of semaglutide compared with liraglutide and placebo for weight loss in patients with obesity: a randomised, double-blind, placebo and active controlled, dose-ranging, phase 2 trial. Lancet. 2018 Aug 25;392(10148):637-649. doi: 10.1016/S0140-6736(18)31773-2. Epub 2018 Aug 16.
- Background: PubMed 19853906Astrup A, Rossner S, Van Gaal L, Rissanen A, Niskanen L, Al Hakim M, Madsen J, Rasmussen MF, Lean ME; NN8022-1807 Study Group. Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study. Lancet. 2009 Nov 7;374(9701):1606-16. doi: 10.1016/S0140-6736(09)61375-1. Epub 2009 Oct 23.
- Background: PubMed 31359088Zatorski H, Salaga M, Fichna J. Role of glucagon-like peptides in inflammatory bowel diseases-current knowledge and future perspectives. Naunyn Schmiedebergs Arch Pharmacol. 2019 Nov;392(11):1321-1330. doi: 10.1007/s00210-019-01698-z. Epub 2019 Jul 29.
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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.
Adela VOICAN, MD principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GLP1 analogues in people with Inflammatory Bowel Diseases and Diabetes Mellitus, Type 2, run by Fondation Hôpital Saint-Joseph 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 0 inclusion and 14 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 7 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adela VOICAN, MD (144127608 ext. +33, avoican@ghpsj.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic control (time frame: Month 6). 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 NCT05196958, which also lists 11 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 7 Mar 2023.