Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06451055
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-05-31
Brief Title:
Low-calorie Diet in Isolated Impaired Fasting Glucose
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Effect of Dietary Energy Restriction on Reversing Isolated Impaired Fasting Glucose A Proof of Concept Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
This study aims to evaluate the preliminary efficacy of a low-calorie diet LCD intervention in addressing the underlying pathophysiological abnormalities and improving fasting hyperglycemia among individuals with i-IFG Additionally it seeks to assess the feasibility and acceptability of the LCD intervention
Detailed Description:
This proof-of-concept randomized controlled trial RCT will enroll 34 individuals aged 35-65 years with overweight or obesity and isolated impaired fasting glucose Intervention participants will adhere to an 8-week low-calorie dietary LCD regimen 1320 kcalday comprising specific macronutrient proportions 55 carbohydrate 13 fat 25 protein and 2 fiber Control participants will maintain their habitual dietary habits and physical activity levels Primary outcomes at 8 weeks include between-group changes in weight fasting plasma glucose indices of ß-cell function and hepatic insulin resistance and alanine aminotransferase levels Secondary outcomes are feasibility metrics response rate screening yield enrollment rate intervention compliance cost staff time and retention rate and intervention acceptability Qualitative research will explore facilitators barriers acceptability satisfaction and participant experiences with the LCD intervention
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