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Nutritional Therapy

Vegetarian Keto Diet for Type 2 Diabetes (DT2-OFF Trial)

N/A
Waitlist Available
Research Sponsored by BloomedIn
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 min after each meal, during the first 2 months and the last 2 months
Awards & highlights

DT2-OFF Trial Summary

This trial will examine if a vegan diet can help type 2 diabetics better manage their blood sugar. It will also look at the role of the gut microbiome in metabolic diseases.

Who is the study for?
This trial is for adults aged 18 to 70 with Type 2 diabetes who are currently on medication for their condition. It's not suitable for those with abnormal C-peptide levels, Type 1 diabetes, anyone already on a ketogenic or vegan diet for over a month, or pregnant/breastfeeding women.Check my eligibility
What is being tested?
The study compares the effects of two types of ketogenic diets on Type 2 diabetes management: one vegetarian and one omnivore. It will explore how these diets impact blood sugar control and gut microbes by analyzing participants' microbiome and daily breath tests.See study design
What are the potential side effects?
Potential side effects may include digestive changes due to diet alteration, possible nutrient deficiencies if the diet isn't well-planned, and initial symptoms like fatigue or irritability as the body adapts to ketosis.

DT2-OFF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 min after each meal, during the first 2 months and the last 2 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 min after each meal, during the first 2 months and the last 2 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline CRP
Change from baseline HbA1c
Insulin
+1 more
Secondary outcome measures
Gallium
Body Weight Changes

DT2-OFF Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Vegetarian ketogenic dietExperimental Treatment1 Intervention
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
Group II: Omnivor ketogenic dietActive Control1 Intervention
Participants will be required to eat a diet that is very low in carbohydrates, moderate in animal protein, with added healthy fats.

Find a Location

Who is running the clinical trial?

BloomedInLead Sponsor
Institut universitaire de cardiologie et de pneumologie de Québec, University LavalOTHER
18 Previous Clinical Trials
3,464 Total Patients Enrolled
1 Trials studying Diabetes Mellitus
150 Patients Enrolled for Diabetes Mellitus
Institut universitaire de cardiologie et de pneumologie de QuébecUNKNOWN
3 Previous Clinical Trials
1,969 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the eligibility criterion of this trial encompass individuals that are over 25 years old?

"This research endeavour is enrolling adults aged between 18 and 70."

Answered by AI

Are there slots still available for prospective participants in this research program?

"As found on clinicaltrials.gov, this study is not currently enrolling participants; the original posting date was May 11th 2022 and there has been no updates since October 13th 2022. Nonetheless, 2472 other trials are actively seeking patients for their studies."

Answered by AI

Is my eligibility within the parameters of this clinical experiment?

"This research initiative is looking for 19 participants with hypertension who are aged between eighteen and seventy. The applicants must also have been diagnosed with Type 2 diabetes, be under medical treatment for the condition, and fit within the aforementioned age range."

Answered by AI

Who else is applying?

What site did they apply to?
Elna Clinic
What portion of applicants met pre-screening criteria?
Met criteria
~7 spots leftby Apr 2025