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

Hypertension Clinical Trial

— DT2-OFF  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05579561
• Other study ID #: DT2-OFF
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 11, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: July 2023
• Source: BloomedIn
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 19
• Est. completion date: December 30, 2023
• Est. primary completion date: November 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2 in Obese
• Diabetes Mellitus Type 2 With Hyperglycemia
• Diabetes Mellitus, Type 2
• Dysbiosis
• Hyperglycemia
• Hypertension
• Inflammation

Intervention

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.

Locations

Country	Name	City	State
Canada	Elna Clinic	Saint-Mathieu	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
BloomedIn	Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Country where clinical trial is conducted

Canada, 

References & Publications (9)

Athinarayanan 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-Ye — View Citation

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. — View Citation

Goldenberg 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. — View Citation

Gurung 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. — View Citation

Kahleova 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. — View Citation

Khazrai 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. — View Citation

Lin 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. — View Citation

Rezaie 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. — View Citation

Wang 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline and week 26
Primary	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	Baseline and week 26
Primary	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	Baseline and week 26
Primary	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	Baseline and week 26
Secondary	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	90 min after each meal, during the first 2 months and the last 2 months
Secondary	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	Baseline and week 26