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Behavioral Intervention

Low-fat Vegan Diet for Type 2 Diabetes

N/A

Recruiting

Led By Hana Kahleova, MD, PhD

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

Men and women with type 2 diabetes treated by diet and/or oral hypoglycemic agents other than sulfonylureas

Medications (antidiabetic, antihypertensive, and lipid-lowering) have been stable for the past 3 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16-weeks

Awards & highlights

Study Summary

This trial will assess health benefits of a vegan diet on diabetes by providing weekly nutrition classes & 1-on-1 dietitian consults for free.

Who is the study for?

Adults with type 2 diabetes, BMI of 26-40, stable medication use for the past 3 months, and HbA1c levels between 6.5-10.5% can join this trial. Excluded are those using recreational drugs or smoking recently, pregnant women or those planning pregnancy, individuals with unstable health conditions or eating disorders, non-English speakers, heavy drinkers, and anyone already on a low-fat vegan diet.Check my eligibility

What is being tested?

This study tests how a low-fat vegan diet affects insulin sensitivity and blood sugar control in type 2 diabetes over a period of 16 weeks. Participants will receive free nutrition education classes and consultations with dietitians to help them follow the dietary plan.See study design

What are the potential side effects?

While not typical for dietary interventions like a low-fat vegan diet to have severe side effects compared to medications or surgeries, participants may experience changes in digestion such as bloating or gas initially as their bodies adjust to the new diet.

Eligibility Criteria

Inclusion Criteria

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

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I have type 2 diabetes and am treated with diet or pills, but not sulfonylureas.

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My medications for diabetes, high blood pressure, and cholesterol have been the same for the last 3 months.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16-weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16-weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16-weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Advanced Glycation End-products (AGE)

Body Composition

Body Weight

+6 more

Secondary outcome measures

Diet Quality

Food Acceptability

Food Cost

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intervention Group: low-fat vegan dietExperimental Treatment1 Intervention

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Yale UniversityOTHER

1,853 Previous Clinical Trials

2,738,541 Total Patients Enrolled

64 Trials studying Diabetes Mellitus

5,760 Patients Enrolled for Diabetes Mellitus

Physicians Committee for Responsible MedicineLead Sponsor

29 Previous Clinical Trials

2,605 Total Patients Enrolled

8 Trials studying Diabetes Mellitus

1,194 Patients Enrolled for Diabetes Mellitus

Hana Kahleova, MD, PhDPrincipal InvestigatorPhysicians Committee for Responsible Medicine

3 Previous Clinical Trials

215 Total Patients Enrolled

2 Trials studying Diabetes Mellitus

95 Patients Enrolled for Diabetes Mellitus

Frequently Asked Questions

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

Is there availability for enrolment in this clinical investigation?

"This study, initially published on January 1st 2024 and last modified on October 24th 2023 is not presently recruiting participants. Nevertheless, there are 1567 other trials actively seeking patients at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Effect of a Low-fat Vegan Dietary Intervention on Intracellular Lipid, Insulin Sensitivity, and Glycemic Control in Type 2 Diabetes

2024. "The Effect of a Low-fat Vegan Dietary Intervention on Intracellular Lipid, Insulin Sensitivity, and Glycemic Control in Type 2 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06106035.