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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks, 1 year, and 2 years

Awards & highlights

Study Summary

This trial examines if nutrition education can improve health and lower costs for Blue Cross Blue Shield subscribers.

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.Check my eligibility

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.See study design

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

Select...

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.

Select...

I am 18 years old or older.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Body Weight

HbA1C

Medical Utilization

+1 more

Secondary outcome measures

Diet Acceptability

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 / 3Eligibility criteria met

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

22 Previous Clinical Trials

272,643 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have been recruited for this clinical trial?

"Indeed, clinicaltrials.gov confirms that this medical trial is actively seeking participants since it was initially posted on the 10th of July 2023 and last updated on 21st of June 2023. The study aims to enrol 700 patients from one location."

Answered by AI

Are participants being recruited presently for this research?

"As evidenced on clinicaltrials.gov, this experiment is recruiting participants at the present moment in time. It was initially uploaded to the website on July 10th 2023 and last amended on June 21st 2023."

Answered by AI