What side effects are associated with this type of intervention?

Common treatments for Diabetes Mellitus, particularly those involving dietary interventions such as low-carbohydrate diets, can have several side effects. These may include nutrient deficiencies due to restricted food groups, gastrointestinal issues like constipation or diarrhea, and potential increases in cholesterol levels. Additionally, patients may experience initial fatigue or headaches as the body adjusts to a lower carbohydrate intake. It is important to monitor these side effects and consult with healthcare providers to ensure a balanced and effective treatment plan.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Diabetes Mellitus that focus on glycemic control and may have effects on the gut microbiota. Metformin, a first-line treatment, reduces blood glucose levels and alters the gut microbiome. GLP-1 receptor agonists like liraglutide and semaglutide are also approved and are known for their efficacy in lowering blood glucose and promoting weight loss, with additional cardiovascular benefits. These treatments align with the goals of the Vegan Low-Carbohydrate Diet trial, which aims to control glycemia and modulate the gut microbiota.

What other types of research exist?

<ol> <li>Plant-Based Meals: These have shown potential in improving beta-cell function and stimulating incretin and insulin secretion in type 2 diabetes patients.</li> <li></li> </ol> Mung Bean-Based Diets: Both whole and decorticated mung beans have demonstrated beneficial effects on serum glucose regulation and lipid disorders, as well as positive modulation of gut microbiota. 3. Synbiotic Yogurt with Monk Fruit Extract: This has been effective in regulating blood glucose, reducing insulin resistance, and improving gut microbiota in type 2 diabetes models. 4. East Asian Diet-Mimicking Plan: Based on the Mediterranean and DASH diets, this plan has shown glycemic benefits in type 2 diabetes patients. 5. Resistant Starch Encapsulated Ganoderma Lucidum Spores: This combination has shown hypoglycemic effects and beneficial impacts on glucose and lipid metabolism, as well as gut microbiota in diabetic rats.

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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

No Placebo-Only Group

Summary

This trial is testing a diet with very few carbohydrates that is entirely plant-based to help people with type 2 diabetes manage their blood sugar levels. The diet aims to reduce blood sugar spikes and improve gut health. Researchers hope this approach will offer better control of diabetes compared to traditional diets. Plant-based diets have been shown to be effective in managing type 2 diabetes by reducing blood sugar levels and improving overall health.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 min after each meal, during the first 2 months and the last 2 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline CRP

Change from baseline HbA1c

Insulin

+1 more

Secondary study objectives

Gallium

Body Weight Changes

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Diabetes Mellitus, particularly dietary interventions like a vegan low-carbohydrate diet, work by restricting carbohydrate intake to manage blood sugar levels and modulating the gut microbiota. Carbohydrate restriction helps reduce postprandial glucose spikes, thereby improving glycemic control. Additionally, a vegan diet rich in fiber and plant-based nutrients can positively alter gut microbiota composition, which is linked to improved metabolic health and reduced inflammation. These mechanisms are crucial for Diabetes Mellitus patients as they help in maintaining stable blood glucose levels, reducing the risk of complications, and potentially improving overall metabolic health.

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