Diabetes Mellitus Type 2 in ObeseDT2-OFFNCT05579561
Vegetarian Ketogenic Diet VS Omnivore Ketogenic Diet - Protocol of a Keto-vege Diet for Remission of Type 2 Diabetes
A study testing Diet in people with Diabetes Mellitus Type 2 in Obese and Hypertension, run by BloomedIn at 1 site in Canada.
Trial summary
Diabetes is one of the biggest public health challenges of the 21st century because of the costs associated with its management, which are estimated at more than three billion dollars per year in Quebec. This cost has been growing steadily for 20 years now. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus Type 2 in Obese, Hypertension, Diabetes Mellitus Type 2 With Hyperglycemia
- What is being tested?
- Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteCanada
- Study dates
- 11 May 2022to 30 Dec 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- Under medication to treat type 2 diabetes
- Aged ≥ 18 years through 70 years
Who cannot join
- Type 1 diabetes
- Aged <18 years or >70 years
- Abnormal or low blood C-peptide by standard laboratory measurements.
- Have already initiated the change to ketogenic or vegan diet for more than 1 month.
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is the Vegetarian Version of Therapeutic Carbohydrate Restriction as Effective as the Omnivore Version: In the Context of Remission of Type 2 Diabetes
Diabetes is one of the biggest public health challenges of the 21st century because of the costs associated with its management, which are estimated at more than three billion dollars per year in Quebec. This cost has been growing steadily for 20 years now. A person with controlled diabetes mobilizes three times more medical resources than a person without diabetes (Diabetes Quebec, 2009). This amount increases rapidly with the associated complications. Therapeutic carbohydrate restriction (in an omnivorous context) used specifically to control glycemia is being studied more and more, but has never been verified in a vegan context. Some studies show that a vegan diet could be an effective way to help type 2 diabetics (T2DM) to better manage their blood sugar. Thus, it is necessary to question whether these effects can be accentuated in the context of a low or very low carbohydrate diet. Numerous publications have highlighted the role of the gut microbiota in metabolic diseases, including T2DM. Analysis of the microbiome before and after dietary change combined with daily breath testing will tell us more about possible intolerances and the role of the microbiome in T2DM management. Given the novelty of these hypotheses and its absence in the literature, it is relevant to undertake a first pilot project with a smaller number of participants in order to obtain preliminary data that will allow us to define more precisely the research avenues for a subsequent study.
Read the detailed description
In recent years, there has been an explosion in the prevalence of obesity and type 2 diabetes (T2DM) worldwide. Obesity, high blood pressure, excessive insulin secretion and other risk factors are precursors to serious or chronic health problems such as diabetes. Type 2 diabetes, which affects more than 8.1% of the Quebec population (2017-2018), has an average annual increase in prevalence of 3.3%, not to mention its devastating direct and indirect consequences on cardiometabolic health and its astronomical costs for the health system.This is now a global concern for which researchers, health experts, and physicians are working together to find practical solutions. In 2016, more than 3.8 million deaths were directly attributed to diabetes or high blood sugar. The number of indirect deaths related to diabetes, however, is difficult to estimate. Despite this, there are strong evidences that diabetes increases the risk of cardiovascular disease, stroke and kidney failure.
Many physicians around the world use low-carbohydrate or ketogenic diets to reverse T2DM. Dr. Evelyne Bourdua-Roy, of the Reversa Clinic, has been doing that since January 2017. Over 2000 patients have chosen the clinic to eat differently in order to learn to better manage their obesity, hypertension, type 2 diabetes and related comorbidities. As a result of the strategies proposed by the Reversa Clinic, many medications are regularly reduced or completely stopped as a result of the changes made in the patients' diet. This results in substantial savings for patients and the health care system. It also results in improved patient health (glycated hemoglobin [HbA1c], C-reactive protein [CRP], hypertension, etc.). New guidelines released by the American Diabetes Association, Diabetes Australia and Diabetes UK now recognize low and very low carbohydrate diets as secure and effective treatments to improve blood sugar levels and to help manage blood sugar variations and thus better manage this disease. With over 8% of the population affected by the disease, Diabetes Canada issued a statement to this effect in the spring of 2020.
The low-carbohydrate diet in an omnivorous context is being studied more and more, but has never been verified in a vegetarian context.
Several studies show that a vegan diet may be an effective way to help T2DM's better manage their blood glucose. Thus, one must question whether these effects can be accentuated in the context of a low or very low carbohydrate diet. Given the novelty of this hypothesis and its absence in the literature, it is relevant to undertake a first pilot project with a smaller number of participants in order to obtain preliminary data that will allow us to define more precisely the research avenues for a subsequent study.
- Conditions
- Diabetes Mellitus Type 2 in Obese, Hypertension, Diabetes Mellitus Type 2 With Hyperglycemia, Inflammation, Dysbiosis
- Being tested
- Diet
- Keywords
- Diabetes Mellitus Type 2, Hyperglycemia, Inflammation, Dysbiosis, Obesity, ketogenic diet, carbs restriction
- Medical subject headings
- Hypertension, Inflammation, Dysbiosis, Diabetes Mellitus, Type 2, Hyperglycemia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
Also called Device
Participants, in both groups, will be required to eat a diet that is very low in carbohydrates, moderate in protein, with added healthy fats. They will also have to breath in the device to estimate the level of different exhale gaz.
| Study group | Role | What they receive |
|---|---|---|
| Vegetarian ketogenic diet | Experimental | Participants will be required to eat a diet that is very low in carbohydrates, moderate in vegetarian proteins, including fish and eggs, with added healthy fats Receives: Other: Diet |
| Omnivor ketogenic diet | Active comparator | Participants will be required to eat a diet that is very low in carbohydrates, moderate in animal protein, with added healthy fats. Receives: Other: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline HbA1c
Complete blood workup including the HbA1c , are done at the beginning and at the end of the 6 months to measure the improvement of glycated hemoglobin
Measured: Baseline and week 26
Change from baseline CRP
Complete blood workup including the C reactive protein , are done at the beginning and at the end of the 6 months to measure the improvement of the CRP
Measured: Baseline and week 26
Change from baseline of fasting insulin
Complete blood workup including the 14 hours fasting insulin , are done at the beginning and at the end of the 6 months to measure the improvement of insulinemia
Measured: Baseline and week 26
Change from baseline of triglycerides
Complete blood workup including triglycerides , are done at the beginning and at the end of the 6 months to measure the improvement of the lipid profil
Measured: Baseline and week 26
Secondary outcomes (2)
Change in the digestive gaz exhale after meal
Breath tests done after each meal to show the decrease in inflammation and indigestion via the concentration of certain gaz like N2
Measured: 90 min after each meal, during the first 2 months and the last 2 months
Change in the microbiome
Analysis of faeces (16-s) at the beginning and at the end, in order to see the changes on the population of bacteria colonies in the digestive tract
Measured: Baseline and week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start11 May 2022
- Primary completion11 Nov 2022
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 2 in ObeseStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- In a clinical study pilot project, compare vegetarian therapeutic carbohydrates restriction to the omnivore version, in the contexte of reverse type 2 diabetes symptoms
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- BloomedIn
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Responsible party
- Sponsor
- Investigators
- Andre Marette, Study director, Institut universitaire de cardiologie et de pneumologie de Quebec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05579561
- Sponsor's protocol ID
- DT2-OFF
- Acronym
- DT2-OFF
- Status last verified
- Jul 2023
- First submitted
- 11 Oct 2022
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Diabetes Canada Position Statement on Low-Carbohydrate Diets for Adults With Diabetes: A Rapid Review. Can J Diabetes. 2020 Jun;44(4):295-299. doi: 10.1016/j.jcjd.2020.04.001. Epub 2020 Apr 24. No abstract available.
PubMed 32475469Goldenberg JZ, Day A, Brinkworth GD, Sato J, Yamada S, Jonsson T, Beardsley J, Johnson JA, Thabane L, Johnston BC. Efficacy and safety of low and very low carbohydrate diets for type 2 diabetes remission: systematic review and meta-analysis of published and unpublished randomized trial data. BMJ. 2021 Jan 13;372:m4743. doi: 10.1136/bmj.m4743.
PubMed 33441384Gurung M, Li Z, You H, Rodrigues R, Jump DB, Morgun A, Shulzhenko N. Role of gut microbiota in type 2 diabetes pathophysiology. EBioMedicine. 2020 Jan;51:102590. doi: 10.1016/j.ebiom.2019.11.051. Epub 2020 Jan 3.
PubMed 31901868Khazrai YM, Defeudis G, Pozzilli P. Effect of diet on type 2 diabetes mellitus: a review. Diabetes Metab Res Rev. 2014 Mar;30 Suppl 1:24-33. doi: 10.1002/dmrr.2515.
PubMed 24352832Rezaie A, Buresi M, Lembo A, Lin H, McCallum R, Rao S, Schmulson M, Valdovinos M, Zakko S, Pimentel M. Hydrogen and Methane-Based Breath Testing in Gastrointestinal Disorders: The North American Consensus. Am J Gastroenterol. 2017 May;112(5):775-784. doi: 10.1038/ajg.2017.46. Epub 2017 Mar 21.
PubMed 28323273Athinarayanan SJ, Adams RN, Hallberg SJ, McKenzie AL, Bhanpuri NH, Campbell WW, Volek JS, Phinney SD, McCarter JP. Long-Term Effects of a Novel Continuous Remote Care Intervention Including Nutritional Ketosis for the Management of Type 2 Diabetes: A 2-Year Non-randomized Clinical Trial. Front Endocrinol (Lausanne). 2019 Jun 5;10:348. doi: 10.3389/fendo.2019.00348. eCollection 2019.
PubMed 31231311Lin CL, Huang LC, Chang YT, Chen RY, Yang SH. Effectiveness of Health Coaching in Diabetes Control and Lifestyle Improvement: A Randomized-Controlled Trial. Nutrients. 2021 Oct 29;13(11):3878. doi: 10.3390/nu13113878.
PubMed 34836135Kahleova H, Matoulek M, Malinska H, Oliyarnik O, Kazdova L, Neskudla T, Skoch A, Hajek M, Hill M, Kahle M, Pelikanova T. Vegetarian diet improves insulin resistance and oxidative stress markers more than conventional diet in subjects with Type 2 diabetes. Diabet Med. 2011 May;28(5):549-59. doi: 10.1111/j.1464-5491.2010.03209.x.
PubMed 21480966Wang LL, Wang Q, Hong Y, Ojo O, Jiang Q, Hou YY, Huang YH, Wang XH. The Effect of Low-Carbohydrate Diet on Glycemic Control in Patients with Type 2 Diabetes Mellitus. Nutrients. 2018 May 23;10(6):661. doi: 10.3390/nu10060661.
PubMed 29882884
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Vegetarian Version of Therapeutic Carbohydrate Restriction as Effective as the Omnivore Version: In the Context of Remission of Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05579561
- Acronym / sponsor ID
- DT2-OFF / DT2-OFF
- Conditions
- Diabetes Mellitus Type 2 in Obese, Hypertension, Diabetes Mellitus Type 2 With Hyperglycemia, Inflammation, Dysbiosis
- Keywords
- Diabetes Mellitus Type 2, Hyperglycemia, Inflammation, Dysbiosis, Obesity, ketogenic diet, carbs restriction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 19 participants (actual)
- Lead sponsor
- BloomedInIndustry (pharma, biotech, devices)
- Collaborators
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Study start
- 11 May 2022 (actual)
- Primary completion
- 11 Nov 2022 (actual)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 14 Oct 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.
Diabetes is one of the biggest public health challenges of the 21st century because of the costs associated with its management, which are estimated at more than three billion dollars per year in Quebec. This cost has been growing steadily for 20 years now. A person with controlled diabetes mobilizes three times more medical resources than a person without diabetes (Diabetes Quebec, 2009). This amount increases rapidly with the associated complications. Therapeutic carbohydrate restriction (in an omnivorous context) used specifically to control glycemia is being studied more and more, but has never been verified in a vegan context. Some studies show that a vegan diet could be an effective way to help type 2 diabetics (T2DM) to better manage their blood sugar. Thus, it is necessary to question whether these effects can be accentuated in the context of a low or very low carbohydrate diet. Numerous publications have highlighted the role of the gut microbiota in metabolic diseases, including T2DM. Analysis of the microbiome before and after dietary change combined with daily breath testing will tell us more about possible intolerances and the role of the microbiome in T2DM management. Given the novelty of these hypotheses and its absence in the literature, it is relevant to undertake a first pilot project with a smaller number of participants in order to obtain preliminary data that will allow us to define more precisely the research avenues for a subsequent study.
Detailed description
In recent years, there has been an explosion in the prevalence of obesity and type 2 diabetes (T2DM) worldwide. Obesity, high blood pressure, excessive insulin secretion and other risk factors are precursors to serious or chronic health problems such as diabetes. Type 2 diabetes, which affects more than 8.1% of the Quebec population (2017-2018), has an average annual increase in prevalence of 3.3%, not to mention its devastating direct and indirect consequences on cardiometabolic health and its astronomical costs for the health system.This is now a global concern for which researchers, health experts, and physicians are working together to find practical solutions. In 2016, more than 3.8 million deaths were directly attributed to diabetes or high blood sugar. The number of indirect deaths related to diabetes, however, is difficult to estimate. Despite this, there are strong evidences that diabetes increases the risk of cardiovascular disease, stroke and kidney failure.
Many physicians around the world use low-carbohydrate or ketogenic diets to reverse T2DM. Dr. Evelyne Bourdua-Roy, of the Reversa Clinic, has been doing that since January 2017. Over 2000 patients have chosen the clinic to eat differently in order to learn to better manage their obesity, hypertension, type 2 diabetes and related comorbidities. As a result of the strategies proposed by the Reversa Clinic, many medications are regularly reduced or completely stopped as a result of the changes made in the patients' diet. This results in substantial savings for patients and the health care system. It also results in improved patient health (glycated hemoglobin [HbA1c], C-reactive protein [CRP], hypertension, etc.). New guidelines released by the American Diabetes Association, Diabetes Australia and Diabetes UK now recognize low and very low carbohydrate diets as secure and effective treatments to improve blood sugar levels and to help manage blood sugar variations and thus better manage this disease. With over 8% of the population affected by the disease, Diabetes Canada issued a statement to this effect in the spring of 2020.
The low-carbohydrate diet in an omnivorous context is being studied more and more, but has never been verified in a vegetarian context.
Several studies show that a vegan diet may be an effective way to help T2DM's better manage their blood glucose. Thus, one must question whether these effects can be accentuated in the context of a low or very low carbohydrate diet. Given the novelty of this hypothesis and its absence in the literature, it is relevant to undertake a first pilot project with a smaller number of participants in order to obtain preliminary data that will allow us to define more precisely the research avenues for a subsequent study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In a clinical study pilot project, compare vegetarian therapeutic carbohydrates restriction to the omnivore version, in the contexte of reverse type 2 diabetes symptoms
| Arm | Type | Receives |
|---|---|---|
| Vegetarian ketogenic diet | Experimental | Other: DietParticipants will be required to eat a diet that is very low in carbohydrates, moderate in vegetarian proteins, including fish and eggs, with added healthy fats |
| Omnivor ketogenic diet | Active comparator | Other: DietParticipants will be required to eat a diet that is very low in carbohydrates, moderate in animal protein, with added healthy fats. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes
- Under medication to treat type 2 diabetes
- Aged ≥ 18 years through 70 years
Key exclusion criteria (5 listed)
- Type 1 diabetes
- Aged <18 years or >70 years
- Abnormal or low blood C-peptide by standard laboratory measurements.
- Have already initiated the change to ketogenic or vegan diet for more than 1 month.
- Pregnant or breastfeeding women
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 |
|---|---|---|
| DietAlso: DeviceParticipants, in both groups, will be required to eat a diet that is very low in carbohydrates, moderate in protein, with added healthy fats. They will also have to breath in the device to estimate the level of different exhale gaz. | Other | Omnivor ketogenic diet, Vegetarian ketogenic diet |
Primary outcome
Change from baseline HbA1c
Time frame: Baseline and week 26
Complete blood workup including the HbA1c , are done at the beginning and at the end of the 6 months to measure the improvement of glycated hemoglobin
Change from baseline CRP
Time frame: Baseline and week 26
Complete blood workup including the C reactive protein , are done at the beginning and at the end of the 6 months to measure the improvement of the CRP
Change from baseline of fasting insulin
Time frame: Baseline and week 26
Complete blood workup including the 14 hours fasting insulin , are done at the beginning and at the end of the 6 months to measure the improvement of insulinemia
Change from baseline of triglycerides
Time frame: Baseline and week 26
Complete blood workup including triglycerides , are done at the beginning and at the end of the 6 months to measure the improvement of the lipid profil
2 secondary outcomes
Change in the digestive gaz exhale after meal
Time frame: 90 min after each meal, during the first 2 months and the last 2 months
Change in the microbiome
Time frame: Baseline and week 26
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Background: PubMed 32475469Diabetes Canada Position Statement on Low-Carbohydrate Diets for Adults With Diabetes: A Rapid Review. Can J Diabetes. 2020 Jun;44(4):295-299. doi: 10.1016/j.jcjd.2020.04.001. Epub 2020 Apr 24. No abstract available.
- Background: PubMed 33441384Goldenberg JZ, Day A, Brinkworth GD, Sato J, Yamada S, Jonsson T, Beardsley J, Johnson JA, Thabane L, Johnston BC. Efficacy and safety of low and very low carbohydrate diets for type 2 diabetes remission: systematic review and meta-analysis of published and unpublished randomized trial data. BMJ. 2021 Jan 13;372:m4743. doi: 10.1136/bmj.m4743.
- Background: PubMed 31901868Gurung M, Li Z, You H, Rodrigues R, Jump DB, Morgun A, Shulzhenko N. Role of gut microbiota in type 2 diabetes pathophysiology. EBioMedicine. 2020 Jan;51:102590. doi: 10.1016/j.ebiom.2019.11.051. Epub 2020 Jan 3.
- Background: PubMed 24352832Khazrai YM, Defeudis G, Pozzilli P. Effect of diet on type 2 diabetes mellitus: a review. Diabetes Metab Res Rev. 2014 Mar;30 Suppl 1:24-33. doi: 10.1002/dmrr.2515.
- Background: PubMed 28323273Rezaie A, Buresi M, Lembo A, Lin H, McCallum R, Rao S, Schmulson M, Valdovinos M, Zakko S, Pimentel M. Hydrogen and Methane-Based Breath Testing in Gastrointestinal Disorders: The North American Consensus. Am J Gastroenterol. 2017 May;112(5):775-784. doi: 10.1038/ajg.2017.46. Epub 2017 Mar 21.
- Results publication: PubMed 31231311Athinarayanan SJ, Adams RN, Hallberg SJ, McKenzie AL, Bhanpuri NH, Campbell WW, Volek JS, Phinney SD, McCarter JP. Long-Term Effects of a Novel Continuous Remote Care Intervention Including Nutritional Ketosis for the Management of Type 2 Diabetes: A 2-Year Non-randomized Clinical Trial. Front Endocrinol (Lausanne). 2019 Jun 5;10:348. doi: 10.3389/fendo.2019.00348. eCollection 2019.
- Results publication: PubMed 34836135Lin CL, Huang LC, Chang YT, Chen RY, Yang SH. Effectiveness of Health Coaching in Diabetes Control and Lifestyle Improvement: A Randomized-Controlled Trial. Nutrients. 2021 Oct 29;13(11):3878. doi: 10.3390/nu13113878.
- Results publication: PubMed 21480966Kahleova H, Matoulek M, Malinska H, Oliyarnik O, Kazdova L, Neskudla T, Skoch A, Hajek M, Hill M, Kahle M, Pelikanova T. Vegetarian diet improves insulin resistance and oxidative stress markers more than conventional diet in subjects with Type 2 diabetes. Diabet Med. 2011 May;28(5):549-59. doi: 10.1111/j.1464-5491.2010.03209.x.
- Results publication: PubMed 29882884Wang LL, Wang Q, Hong Y, Ojo O, Jiang Q, Hou YY, Huang YH, Wang XH. The Effect of Low-Carbohydrate Diet on Glycemic Control in Patients with Type 2 Diabetes Mellitus. Nutrients. 2018 May 23;10(6):661. doi: 10.3390/nu10060661.
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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.
Andre Marette study director
Institut universitaire de cardiologie et de pneumologie de Quebec
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet in people with Diabetes Mellitus Type 2 in Obese and Hypertension, run by BloomedIn at 1 site in Canada.
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 3 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: status not confirmed, as of the sponsor's last update on 13 Jul 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 Canada. 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?
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?
Change from baseline HbA1c (time frame: Baseline and week 26). The study lists 4 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 NCT05579561, which also lists 9 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 13 Jul 2023.