Isolated Impaired Fasting Glucose Clinical Trial
Official title:
Effect of Dietary Energy Restriction on Reversing Isolated Impaired Fasting Glucose: A Proof of Concept Study
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.
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 (~1,320 kcal/day) 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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT06143345 -
HIIT in Isolated IFG: A Proof-of-Concept Study
|
N/A | |
| Completed |
NCT00140647 -
The Study of Atherosclerosis With Ramipril and Rosiglitazone
|
Phase 3 |