NCT04944316

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

Physicians Committee for Responsible Medicine - a Randomized, Controlled Study of the Effect of a Low-fat, Plant-based Diet on Insulin Requirements in Individuals with Type 1 Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Physicians Committee for Responsible Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Type 1 diabetes is a chronic autoimmune disorder characterized by loss of β-cell mass and function in the pancreas, leading to reduced secretion of insulin and hyperglycemia. The management of type 1 diabetes requires the administration of exogeneous insulin. Total daily dose (TDD) of insulin, a measure of the total amount of exogeneous insulin utilized per day, can be affected by multiple factors including insulin resistance, carbohydrate intake, body weight, and body composition. While the pathogenesis of type 1 diabetes and type 2 diabetes differ, a low-fat, plant-based diet has been shown to reduce insulin resistance, reduce body weight, improve body composition, and improve glycemic control in individuals with type 2 diabetes. A low-fat, plant-based diet has also been shown to improve β-cell function in individuals who are overweight. This finding is consistent with other research that shows that therapies that reduce body fat, or modify the distribution of body fat, improve β-cell function and glucose homeostasis. To date, a low-fat, plant-based diet has never been adequately tested in adults with type 1 diabetes. The purpose of this study is to compare the effects of low-fat, plant-based dietary intervention and a portion-controlled dietary intervention (compliant with current American Diabetes Association (ADA) guidelines) on insulin requirements in adults with type 1 diabetes. Using a parallel group design, participants with type 1 diabetes will be randomly assigned to follow a low-fat, plant-based diet or a portion-controlled diet (compliant with current ADA guidelines) for 12 weeks. The principal dependent measures of this study are TDD of insulin, hemoglobin A1c (HbA1c), interstitial fluid glucose levels, and 24-hour carbohydrate: insulin ratio. Secondary and tertiary dependent measures include inflammatory biomarkers, blood lipids, body weight, diet quality, diet acceptability, and medication use. The investigators hypothesize that both the low-fat, plant-based dietary intervention and the portion-controlled dietary intervention will elicit changes in insulin requirements, HbA1c, variability in interstitial glucose levels, insulin sensitivity, and body weight in participants with type 1 diabetes. The investigators further hypothesize that the low-fat, plant-based dietary intervention will confer a more substantial effect on changes in insulin requirements, HbA1c, insulin sensitivity, variability in interstitial glucose levels, and body weight in participants with type 1 diabetes.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
BEHAVIORAL	Dietary intervention	Low-fat, plant-based diet
BEHAVIORAL	Dietary intervention	Portion-controlled diet (compliant with ADA guidelines)

Timeline

• Start date: 2022-01-19
• Primary completion: 2022-11-09
• Completion: 2022-11-09
• First posted: 2021-06-29
• Last updated: 2024-09-27

Locations

1 site across 1 country: United States