What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes, particularly those involving dietary changes and lifestyle modifications, generally have minimal side effects. However, some individuals may experience gastrointestinal discomfort, such as bloating or changes in bowel habits, when increasing fiber intake from plant-based diets. Pharmacologic treatments, such as metformin, can cause gastrointestinal issues like nausea, diarrhea, and abdominal pain. Sulfonylureas and insulin can lead to hypoglycemia (low blood sugar), while other medications like DPP-4 inhibitors may cause nasopharyngitis or headaches. Overall, lifestyle modifications are typically well-tolerated and can significantly improve metabolic health with fewer adverse effects compared to pharmacologic treatments.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Type 2 Diabetes, including metformin, which was approved in 1995 and is often recommended as the first-line treatment. Other approved medications include sulfonylureas, DPP-4 inhibitors, and GLP-1 receptor agonists. These pharmacologic therapies are typically used in conjunction with lifestyle modifications such as dietary changes and increased physical activity. The Plant-Based Nutrition Education Program trial focuses on dietary changes to improve metabolic health, which aligns with the broader approach of integrating lifestyle modifications with pharmacologic treatments to manage Type 2 Diabetes effectively.

What other types of research exist?

Promising alternatives to a Plant-Based Nutrition Education Program for Type 2 Diabetes patients include: 1) Black-Grained Wheat (BGW) intake, which has been shown to improve glycemic control and inflammatory profiles. 2) Tartary Buckwheat (TB) intake, which has demonstrated benefits in reducing insulin resistance and improving lipid profiles. 3) An East Asian diet-mimicking plan based on the Mediterranean and DASH diets, which has shown glycemic benefits. 4) A Brown Rice Based Vegan Diet, which has been effective in improving glycemic control. 5) Lentil Sprouts (LS) intake, which has shown significant improvements in lipid profiles.

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Nutrition Education Program

Plant-Based Diet for Type 2 Diabetes (DROP Trial)

N/A

Recruiting

Led By Neal Barnard, MD

Research Sponsored by Physicians Committee for Responsible Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Prior diagnosis of type 2 diabetes mellitus

Be older than 18 years old

Must not have

Lack of English fluency

Unstable medical or psychiatric illness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing an online course that teaches people about eating a plant-based diet. It aims to help community members improve their blood sugar levels, lose weight, and lower cholesterol. The study will see if these health benefits make the program useful for doctors and patients.

Who is the study for?

The DROP Study is for U.S. adults with type 2 diabetes who can maintain their current medication regimen. Participants must be fluent in English and not use recreational drugs, be pregnant, or plan to become pregnant during the study. They should also be able to participate fully in the program.

What is being tested?

This trial tests a 20-week online education program promoting a plant-based diet for people with type 2 diabetes. It aims to see if this approach is practical and effective at lowering blood sugar levels, weight, and cholesterol in a community setting.

What are the potential side effects?

While not explicitly listed, potential side effects may include changes in digestion due to dietary adjustments, possible nutrient deficiencies without proper planning of the plant-based diet, and initial withdrawal symptoms from reducing certain foods.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with type 2 diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not fluent in English.

Select...

I do not have any unstable medical or mental health conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Glycated hemoglobin

Secondary study objectives

LDL cholesterol

body weight

medication usage

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Vegan dietExperimental Treatment1 Intervention

All participants will follow a low-fat vegan diet. There are no other study arms or control group.

0 / 3Eligibility criteria met

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 Type 2 Diabetes include dietary changes, medications, and lifestyle modifications. Plant-based nutrition, as studied in the Plant-Based Nutrition Education Program, emphasizes high intake of fruits, vegetables, whole grains, and legumes, which can improve insulin sensitivity and reduce inflammation. This dietary approach helps lower glycated hemoglobin levels, body weight, and cholesterol, which are crucial for managing diabetes. Medications like metformin work by reducing glucose production in the liver and improving insulin sensitivity. Lifestyle changes, including regular physical activity, enhance glucose uptake by muscles and improve overall metabolic health. These treatments are vital for Type 2 Diabetes patients as they help maintain blood glucose levels, prevent complications, and improve quality of life.

A Group-Based Community Reinforcement Approach of Cognitive Behavioral Therapy Program to Improve Self-Care Behavior of Patients With Type 2 Diabetes.Long-term non-pharmacological weight loss interventions for adults with type 2 diabetes mellitus.Sustaining Effect of Intensive Nutritional Intervention Combined with Health Education on Dietary Behavior and Plasma Glucose in Type 2 Diabetes Mellitus Patients.