An interventional study of Diet in Diabetes Mellitus Type 2 in Obese, Hypertension and Diabetes Mellitus Type 2 With Hyperglycemia, sponsored by BloomedIn. Status unknown at 1 site in Canada. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-07-13.
Sponsored by BloomedIn · Not applicable, Interventional, and Treatment
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.
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.
6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.
This study's enrollment of 19 is below the median of 90 across 5,095 interventional studies indexed under Hypertension.
Browse Hypertension studies →This is the only study on the registry with BloomedIn as lead sponsor.
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Exclusion Criteria:
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
Other: Diet
Participants will be required to eat a diet that is very low in carbohydrates, moderate in animal protein, with added healthy fats.
Other: Diet
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.
Also known as: Device
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and week 26
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
Time frame: 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
Time frame: Baseline and week 26
Ran from May 2022 to primary completion in Nov 2022, 6 months.
Of 94 industry-sponsored interventional studies with no phase under Hypertension, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 58. This study's 6 months is below that.
Counting every sponsor, half of 1,433 studies reached it within 23 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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