NCT05579561: DT2-OFF

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

Status unknown NA Last updated 13 July 2023

What this trial tests

NA trial testing Diet in Diabetes Mellitus Type 2 in Obese in 19 participants. Status unknown.

Timeline

11 May 2022

Primary endpoint
11 November 2022

30 December 2023

Quick facts

Lead sponsor	BloomedIn
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	19
Start date	11 May 2022
Primary completion	11 November 2022
Estimated completion	30 December 2023
Sites	1 location across Canada

Drugs / interventions tested

• Diet

Conditions studied

• Diabetes Mellitus Type 2 in Obese — all drugs for Diabetes Mellitus Type 2 in Obese →
• Hypertension — all drugs for Hypertension →
• Diabetes Mellitus Type 2 With Hyperglycemia — all drugs for Diabetes Mellitus Type 2 With Hyperglycemia →
• Inflammation — all drugs for Inflammation →

Sponsor

BloomedIn

Who can join

Adults 18 to 70, any sex, with Diabetes Mellitus Type 2 in Obese or Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.