DT2-OFF: Vegetarian Ketogenic Diet VS Omnivore Ketogenic Diet - Protocol of a Keto-vege Diet for Remission of Type 2 Diabetes

Sponsor

BloomedIn (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05579561

Collaborator

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval (Other)

Enrollment

Location

Arms

10.6

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus Type 2 in Obese Hypertension Diabetes Mellitus Type 2 With Hyperglycemia Inflammation Dysbiosis	Other: Diet	N/A

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

Study Type:

Interventional

Actual Enrollment :

19 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention 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 symptomsIn 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)

Primary Purpose:

Treatment

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

Actual Study Start Date :

May 11, 2022

Anticipated Primary Completion Date :

Nov 11, 2022

Anticipated Study Completion Date :

Mar 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vegetarian ketogenic diet 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, 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 Names: Device
Active Comparator: Omnivor ketogenic 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. Other Names: Device

Arm

Intervention/Treatment

Experimental: Vegetarian ketogenic diet

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, 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 Names:

Device

Active Comparator: Omnivor ketogenic 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

Other Names:

Device

Outcome Measures

Primary Outcome Measures

Change from baseline HbA1c [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 [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 [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 [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

Secondary Outcome Measures

Change in the digestive gaz exhale after meal [90 min after each meal, during the first 2 months and the last 2 months]
Breath tests done after each meal to show the decrease in inflammation and indigestion via the concentration of certain gaz like N2
Change in the microbiome [Baseline and week 26]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Type 2 diabetes
Under medication to treat type 2 diabetes
Aged ≥ 18 years through 70 years

Exclusion Criteria:

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