Ignite Creation Date:
2024-05-06 @ 1:20 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT03997409
Status:
COMPLETED
Last Update Posted:
2023-05-08
First Post:
2019-06-21
Brief Title:
Impact of a Low-Carbohydrate Diet in Pediatric Type 1 Diabetes
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
Impact of a Low-Carbohydrate Diet on Glycemic Control and Lipids in Pediatric Type 1 Diabetes
Status:
COMPLETED
Status Verified Date:
2022-06
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:
None
Brief Summary:
Dietary carbohydrate consumption is a key factor influencing postprandial glycemia for patients with type 1 diabetes mellitus T1DM Because post-prandial glucose excursions profoundly influence hemoglobin A1c HbA1c therapeutic approaches to mitigate post-prandial hyperglycemia are of great importance The quantity and source of carbohydrates affect post-prandial glycemia more than any other dietary factor These findings serve as the physiologic basis for a growing interest in carbohydrate-restricted diets in the management of T1DM despite American Diabetes Association ADA guidelines that discourage restricting total carbohydrate intake to less than 130 grams per day Although case series and prospective studies suggest low-carbohydrate diets LCD significantly improve HbA1c for adults with T1DM data in the pediatric T1DM population is limited The investigators will conduct a randomized prospective pilot study evaluating glycemic control lipidemia and quality of life QOL in pediatric T1DM patients on a LCD
Detailed Description:
None
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