Ignite Creation Date:
2024-05-06 @ 4:19 PM
Last Modification Date:
2024-10-26 @ 2:08 PM
Study NCT ID:
NCT04944316
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2021-06-21
Brief Title:
Effect of a Dietary Intervention on Insulin Requirements in Type 1 Diabetes
Sponsor:
Physicians Committee for Responsible Medicine
Organization:
Physicians Committee for Responsible Medicine
Study Overview
Official Title:
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
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
T1D
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None