What is the CARING Study studying for type 2 diabetes?

The CARING Study is evaluating how nutrition education and following a low-fat, vegan diet may affect health and healthcare use in people with type 2 diabetes. Researchers aim to understand if this approach can help improve health markers and reduce medical costs over two years.

Who may be eligible for this type 2 diabetes clinical trial?

Adults aged 18 and older with type 2 diabetes who are Blue Cross Blue Shield subscribers may be eligible. Participants should be willing to follow a plant-based diet and attend weekly online classes. People with certain medical conditions or recent bariatric surgery may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this type 2 diabetes clinical trial?

Study-related care, including the nutrition classes and all trial visits, is provided at no cost. Personal expenses like travel may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

Healthy Volunteers

ID05795439

The CARING Study Improving Health in Adults With Type 2 Diabetes Through Nutrition Education and a Low-Fat Vegan Diet

Led by Physicians Committee for Responsible Medicine · Updated on 2026-04-13

700

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to evaluate the health benefits of nutrition education and a low-fat, vegan diet for individuals with type 2 diabetes who are Blue Cross Blue Shield subscribers. The study compares participants who receive nutrition guidance with a control group maintaining their usual diet to assess potential healthcare cost savings and health improvements. Participants in the intervention group will attend weekly online classes on nutrition and health while following a low-fat, vegan diet for 16 weeks. This diet focuses on whole grains, vegetables, legumes, and fruits, with no animal products or added oils, designed to be low in fat and rich in fiber. The control group will continue with their regular diet. Weekly classes continue for two years, and medical and laboratory assessments will be conducted throughout this period. Participants will undergo assessments of body weight, plasma lipids, HbA1C, dietary intake, and adherence at the start and after 16 weeks. Plasma lipids and HbA1C will be measured every six months during the two-year follow-up. Medical utilization data will be tracked for two years to compare health outcomes between groups. The study involves regular evaluations to monitor diet acceptability and health markers, ensuring ongoing support and data collection over the full study duration.

CONDITIONS

Brief Title

The CARING Study: Creating and Restoring Health Through Nutrition Guidance

How This Trial Compares With Other Options

This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.

Factors	Low-fat Vegan Diet (Whole-Food, Plant-Based + Nutrition Guidance)	Usual Diabetes Care (No Additional Dietary Intervention)	Standard Dietary Recommendations for Diabetes (External Context)
What is it?	A structured eating plan based exclusively on whole grains, vegetables, legumes, and fruits, eliminating animal products and added oils, with about 10% of energy from fat. Participants receive nutrition education and group support with weekly online classes for 16 weeks.	Routine diabetes management without a structured diet or added nutrition counseling. Participants continue their usual eating habits and standard clinical care without mandated dietary changes.	Medical nutrition therapy focused on individualized carbohydrate intake, increased dietary fiber, limited added sugars and saturated fat, with encouragement to adopt healthful eating patterns (such as Mediterranean or vegetarian diets) tailored to personal preference and metabolic goals.
Role in the trial	The primary intervention being tested to improve metabolic and clinical outcomes in adults with insulin-treated type 2 diabetes.	Serves as the comparator arm, reflecting patients who receive usual diabetes care without added dietary programming.	Represents the expert-recommended target for nutrition therapy in usual care, guiding diabetes dietary advice outside the context of this specific study.
Primary intended use or purpose	To assess whether a structured low-fat vegan dietary pattern, with education and support, can reduce insulin requirements and improve glycemic and cardiometabolic outcomes among adults with type 2 diabetes treated with insulin.	To provide a control condition reflecting everyday diabetes management and to serve as a comparison for the trial's outcome measures.	To optimize blood glucose control, support weight management, and reduce cardiovascular risk through individualized, evidence-based dietary modifications for people with type 2 diabetes.
How is it given or performed?	Participants receive guidance to follow a low-fat vegan diet for 16 weeks, with group education and support via weekly online classes. There is no restriction on calorie intake.	No dietary changes or educational intervention are introduced by the study; participants continue their self-selected diets and usual care.	Nutrition therapy is provided by a registered dietitian or healthcare provider, emphasizing education, assessment, and personalized dietary planning, typically including ongoing follow-up.
Evidence status / Supporting research	Ongoing investigation; results for this specific trial are not yet established. External systematic reviews suggest plant-based diets may reduce HbA1c, improve lipid profiles, and promote weight loss in people with type 2 diabetes.	Continued standard management is the most common approach for people with type 2 diabetes, but dietary improvements and glycemic benefits depend on individual choices and varied adherence. No additional effect from a structured plant-based intervention is expected.	Dietary modification is an established strategy to improve blood glucose control and reduce cardiovascular risk in type 2 diabetes. Both Mediterranean and plant-based dietary patterns are associated with clinically meaningful cardiometabolic benefits according to consensus guideline statements.
Important limitations	Adherence to a strict vegan diet can be challenging for some individuals. The trial evaluates outcomes only up to 2 years and longer-term sustainability or population-wide effectiveness is not established.	Individual dietary habits and engagement with healthy eating are highly variable, which can limit the generalizability of trial results and real-world metabolic benefits.	Achievement of dietary goals is dependent on patient motivation, access to resources, and ongoing support. Not all patients can maintain recommended dietary changes with equal success.

Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.

Who Can Participate

Age: 18Years +

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Blue Cross Blue Shield subscriber continuously enrolled for the prior 12 months
Male or female
Age at least 18 years
Have a diagnosis of type 2 diabetes
Ability and willingness to participate in all study components including following a plant-based diet for 16 weeks, attending weekly online classes for 16 weeks, and keeping physical activity level consistent during this period

You will not qualify if you...

Diagnosis of type 1 diabetes or endocrine conditions affecting body weight such as pituitary abnormality or Cushing's syndrome
Smoking during the past six months
Alcohol use exceeding 2 drinks per day or history of alcohol abuse with current use
Current or unresolved past drug abuse
Recently gave birth, pregnant, or plans to become pregnant before or during the study
Unstable medical or psychiatric conditions
Cancer diagnosis
Chronic kidney disease stage 4 or 5
Evidence of an eating disorder
Lack of English fluency
Bariatric surgery in the last 6 months
Dementia
Institutional custodial care
End of life or palliative care
Active participation in specific BCBSM diabetes or case management programs

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or online)

Outpatient Treatment

Duration - 16 weeks

Participants in the intervention group attend weekly online classes on nutrition and health and follow a low-fat, vegan diet for 16 weeks.

Weekly online classes for 16 weeks

Follow-up

Duration - 2 years

Participants have their plasma lipids and HbA1C assessed every 6 months during a 2-year follow-up. Weekly online classes continue to be offered during this period. Medical utilization and body weight are tracked at 16 weeks, 1 year, and 2 years.

Assessments every 6 months and weekly online classes for up to 2 years