What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes include pharmacologic options like metformin, acarbose, and semaglutide, as well as non-pharmacologic interventions such as diet and exercise. Metformin is generally well-tolerated but can cause gastrointestinal issues like diarrhea and nausea. Acarbose may lead to gastrointestinal side effects such as flatulence and diarrhea. Semaglutide can cause gastrointestinal symptoms, including nausea and vomiting, and must be continued indefinitely to prevent weight regain. Non-pharmacologic interventions, particularly intensive lifestyle modifications involving diet and exercise, are associated with fewer side effects but require sustained effort and adherence to be effective.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Type 2 Diabetes that align with improving dietary habits and health outcomes. Metformin is often the first-line therapy due to its efficacy in lowering blood glucose levels and its favorable impact on weight. GLP-1 receptor agonists, such as liraglutide and semaglutide, have also been approved and are notable for their ability to promote weight loss and improve glycemic control. These drugs, along with lifestyle interventions focusing on diet and exercise, have shown significant benefits in managing Type 2 Diabetes and potentially reducing healthcare costs.

What other types of research exist?

Promising, novel alternatives to traditional nutrition education for Type 2 Diabetes patients include: 1) Online diabetes nutrition education programs, which leverage internet and smartphone use to provide accessible education. 2) Mobile applications and games designed for self-education and dietary monitoring, which have shown improvements in dietary knowledge and habits. 3) Personalized nutrition education that considers individual patient data and habits, leading to better dietary behaviors and blood parameters. 4) Community-based food education programs that combine exercise and nutrition education, enhancing overall lifestyle and health outcomes.

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Low-Fat Vegan Diet for Type 2 Diabetes

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

Have a diagnosis of type 2 diabetes

Blue Cross Blue Shield subscriber continuously enrolled for the prior 12 months

Must not have

Diabetes mellitus type 1 or history of any endocrine condition that would affect body weight, such as a pituitary abnormality or Cushing's syndrome

Chronic kidney disease, stage 4 or 5

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks, 1 year, and 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial involves online nutrition classes and a low-fat, vegan diet for Blue Cross Blue Shield subscribers with type 2 diabetes. The goal is to see if these changes can improve their health and reduce healthcare costs by teaching them about healthy eating and following a specific diet.

Who is the study for?

Adults over 18 with type 2 diabetes, who are Blue Cross Blue Shield subscribers and have been so for the past year. Participants must be willing to adopt a plant-based diet, attend weekly online classes for 16 weeks, and keep their physical activity level steady.

What is being tested?

The CARING study is testing the effects of a low-fat vegan diet on health outcomes in individuals with type 2 diabetes. It includes nutrition education and aims to evaluate potential healthcare cost savings.

What are the potential side effects?

While not explicitly listed, possible side effects may include digestive changes due to dietary adjustments, nutrient deficiencies if the diet isn't well-planned, and initial symptoms like fatigue or hunger.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with type 2 diabetes.

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I have been enrolled in Blue Cross Blue Shield for the last 12 months.

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I am 18 years old or older.

Exclusion Criteria

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

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I have type 1 diabetes or a condition affecting my weight like Cushing's syndrome.

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My kidney function is severely reduced.

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My health or mental condition is stable.

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I am not fluent in English.

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I have not had weight loss surgery in the past 6 months.

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I am receiving care to manage my cancer symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks, 1 year, and 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16 weeks, 1 year, and 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks, 1 year, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Body Weight

HbA1C

Medical Utilization

+1 more

Secondary study objectives

Diet Acceptability

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: Intervention GroupExperimental Treatment1 Intervention

The Intervention group arm of participants will be asked to attend weekly online classes on nutrition and health and to follow a low-fat, vegan diet for 16 weeks.

Group II: Control GroupActive Control1 Intervention

The Control group arm of participants will be asked to maintain their regular, pre-study diet.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Low-fat, vegan diet

2009

N/A

~50

0 / 9Eligibility 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

The most common treatments for Type 2 Diabetes include lifestyle interventions and pharmacologic therapies. Lifestyle interventions, such as improved diet and increased physical activity, help by reducing body weight, improving insulin sensitivity, and lowering blood glucose levels. These changes can lead to better glycemic control and potentially delay or prevent the progression of diabetes. Pharmacologic treatments like metformin work by decreasing hepatic glucose production and improving insulin sensitivity, while insulin therapy helps to directly lower blood glucose levels by facilitating cellular glucose uptake. These treatments are crucial for Type 2 Diabetes patients as they help manage blood sugar levels, reduce the risk of complications, and improve overall health outcomes.

Cost effectiveness of dietitian-led nutrition therapy for people with type 2 diabetes mellitus: a scoping review.Long-term non-pharmacological weight loss interventions for adults with type 2 diabetes mellitus.Can diabetes prevention programmes be translated effectively into real-world settings and still deliver improved outcomes? A synthesis of evidence.