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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 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

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.

Find a Location

Who is running the clinical trial?

Physicians Committee for Responsible MedicineLead Sponsor
29 Previous Clinical Trials
1,925 Total Patients Enrolled
Blue Cross Blue ShieldOTHER
23 Previous Clinical Trials
272,690 Total Patients Enrolled
Neal Barnard, MDPrincipal InvestigatorPhysicians Committee for Responsible Medicine
9 Previous Clinical Trials
593 Total Patients Enrolled

Media Library

Low-fat, vegan diet (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05795439 — N/A
Type 2 Diabetes Research Study Groups: Control Group, Intervention Group
Type 2 Diabetes Clinical Trial 2023: Low-fat, vegan diet Highlights & Side Effects. Trial Name: NCT05795439 — N/A
Low-fat, vegan diet (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05795439 — N/A
~420 spots leftby Dec 2026