Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06503809
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-27
Brief Title:
Efficacy and Safety of a Ketogenic Diet in Type 1 Diabetes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy and Safety of a Ketogenic Diet in Type 1 Diabetes
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Despite strong evidence that tight control of blood sugar reduces the risk of diabetes complications most people with type 1 diabetes do not achieve recommended blood sugar targets This randomized controlled trial will test whether a very-low- carbohydrate ketogenic diet can effectively and safely improve blood sugar control in adults with type 1 diabetes
Detailed Description:
A very-low-carbohydrate ketogenic diet 50 g carbohydrateday could reduce glycemic variability total daily insulin requirement and HbA1c in people with type 1 diabetes T1D Indeed several case series and observational studies of using a ketogenic diet KD in people with T1D have observed such benefits However no randomized controlled trials RCTs have evaluated the efficacy of KD for 7 days in people with T1D In addition there are serious concerns regarding the safety and tolerability of a KD in patients with T1D including the potential for an increased risk of hypoglycemia diabetic ketoacidosis dyslipidemia insulin resistance decreased bone mineral density and impaired quality of life This study is a 26-week RCT to evaluate the clinical efficacy metabolic function safety socio-behavioral impact acceptability and potential for dissemination of an isocaloric KD compared with an American Diabetes Association-recommended control diet in adults with T1D
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None