← Back to Search

Low-fat, vegan diet for Type 1 Diabetes (T1D Trial)

N/A
Waitlist Available
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from week 0 to week 12
Awards & highlights

T1D Trial Summary

This trial will compare two diets for managing type 1 diabetes in adults. The primary outcome is insulin requirements.

Eligible Conditions
  • Type 1 Diabetes

T1D Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from week 0 to week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from week 0 to week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
24-hour Carbohydrate to Insulin Ratio
Glycemic Control
Glycemic Variability
+1 more
Secondary outcome measures
Body Weight
Concentration of Plasma Lipids
High-sensitivity C-reactive Protein (hs-CRP)
+2 more
Other outcome measures
Diet Acceptability
Diet Quality
Medication Use

T1D Trial Design

2Treatment groups
Active Control
Group I: Low-fat, vegan dietActive Control1 Intervention
For a 12-week period, participants will be asked to follow a low-fat, vegan diet which consists of whole grains, vegetables, legumes, and fruits, with no restriction on energy intake. Animal products and added oils will be excluded. In choosing grain products and starchy vegetables (e.g., bread, potatoes), participants will be encouraged to select those retaining their natural fiber and having a glycemic index <70, using tables standardized to a value of 100 for glucose.
Group II: Portion-controlled dietActive Control1 Intervention
For a 12-week period, participants will be asked to follow a portion-controlled diet that is compliant with American Diabetes Association (ADA) guidelines. This diet will include individualized diet plans that reduce daily energy intake by 500-1,000 kcal for overweight (body mass index > 25 kg/m2) participants and keep carbohydrate intake reasonably stable over time. It will derive 15-20% from protein, <7% saturated fat, 60-70% carbohydrate and monounsaturated fats and ≤200 mg/day of cholesterol/day.

Find a Location

Who is running the clinical trial?

Physicians Committee for Responsible MedicineLead Sponsor
29 Previous Clinical Trials
2,590 Total Patients Enrolled
Hana Kahleova, MD, PhDPrincipal InvestigatorPhysicians Committee for Responsible Medicine
3 Previous Clinical Trials
200 Total Patients Enrolled

Frequently Asked Questions

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

What is the aggregate size of the population being tested in this research?

"Affirmative, the information on clinicaltrials.gov illustrates that this medical trial is presently recruiting applicants. The initial listing was published on January 19th 2022 and last modified April 18th 2022; 30 subjects are needed from a single site."

Answered by AI

What aims does this research endeavor hope to accomplish?

"The primary metric of success for this clinical trial is the ratio of carbohydrates to insulin from baseline at week 0 until 12 weeks. Secondary measures include IL-1, IL-6 as biomarkers for systemic inflammation, plasma cholesterol and triglycerides concentration, and hs-CRP which predicts an individual's cardiovascular risk."

Answered by AI

Is there still capacity for individuals to take part in this experiment?

"Affirmative. Clinicaltrials.gov contains information that indicates this medical experiment is actively recruiting patients, having been published on January 19th 2022 and last renewed on April 18th 2022. The research requires 30 volunteers from a single clinical centre."

Answered by AI
Recent research and studies
Journal of the American Dietetic AssociationJournal
Position of the American Dietetic Association and Dietitians of Canada: Vegetarian Diets
“Position of the American Dietetic Association and Dietitians of Canada: Vegetarian Diets”. 2003. “Position of the American Dietetic Association and Dietitians of Canada: Vegetarian Diets”. Journal of the American Dietetic Association. Elsevier BV. doi:10.1053/jada.2003.50142.
The American Journal of Clinical NutritionJournal
Role of Glycemic Index and Glycemic Load in the Healthy State, in Prediabetes, and in Diabetes
Riccardi, Gabriele, Angela A Rivellese, and Rosalba Giacco. 2008. “Role of Glycemic Index and Glycemic Load in the Healthy State, in Prediabetes, and in Diabetes”. The American Journal of Clinical Nutrition. Oxford University Press (OUP). doi:10.1093/ajcn/87.1.269s.
Medicine & Science in Sports & ExerciseJournal
International Physical Activity Questionnaire: 12-country Reliability and Validity
CRAIG, CORA L., ALISON L. MARSHALL, MICHAEL SJ??STR??M, ADRIAN E. BAUMAN, MICHAEL L. BOOTH, BARBARA E. AINSWORTH, MICHAEL PRATT, et al.. 2003. “International Physical Activity Questionnaire: 12-country Reliability and Validity”. Medicine & Science in Sports & Exercise. Ovid Technologies (Wolters Kluwer Health). doi:10.1249/01.mss.0000078924.61453.fb.
Archives of Family MedicineJournal
Factors That Facilitate Compliance to Lower Fat Intake
Barnard, N. D.. 1995. “Factors That Facilitate Compliance to Lower Fat Intake”. Archives of Family Medicine. CLOCKSS Archive. doi:10.1001/archfami.4.2.153.
~11 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top