Effect of a Dietary Intervention on Insulin Requirements in Type 1 Diabetes

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Type 1

In brief

The purpose of this study is to compare the effects of a low-fat, plant-based dietary intervention and a portion-controlled dietary intervention (compliant with current American Diabetes Association (ADA) guidelines) on the management of type 1 diabetes in adults. The primary outcome measure of this study is insulin requirements (measured as the total daily dose (TDD) of insulin or basal and bolus insulin units injected per day). The study duration is 12 weeks.

Key facts

Study ID

NCT04944316

Run by

Physicians Committee for Responsible Medicine

People needed

35

Starts

2022-01-19

Expected to finish

2022-11-09

Last updated by the study team

2024-09-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Type 1 diabetes
• Men and women ≥ 18 years of age
• Stable insulin regimen for past 3 months

You may not qualify if…

• Type 2 or gestational diabetes
• Body mass index ≥ 40 kg/m2
• HbA1c ≥ 12.0%
• Smoking or drug abuse during the past six months
• Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use
• Unstable medical or psychiatric illness
• Already following a low-fat vegan diet
• Pregnant or breastfeeding, or plans of pregnancy within the study period
• Lack of English fluency
• Unable or unwilling to participate in all components of the study
• Evidence of an eating disorder

Where it is running

• Physicians Committee for Responsible Medicine — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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