Ignite Creation Date:
2024-05-06 @ 6:42 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05754775
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-01-24
First Post:
2023-02-20
Brief Title:
Remission of Type 2 Diabetes Via Calorie Restriction
Sponsor:
Yeouido St Marys Hospital
Organization:
Yeouido St Marys Hospital
Study Overview
Official Title:
Type 2 Diabetes Remission Induced by a Korean Low-calorie Diet A Single Center Pilot Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-01
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:
The primary purpose was to evaluate the efficacy of Korean low-calorie diet for obese adult patients with type 2 diabetes with a body mass index of 25 kgm2 or higher
Detailed Description:
Previous studies reporting the natural course of type 2 diabetes generally reported progressive worsening of the disease However several recent studies suggested that significant weight loss induced by an very-low calorie diet could lead to the improvement in glycemic control that enough to drug discontinuation Considering that improvement in diabetes is not permanent and hyperglycemia may recur American and European expert groups define and express the improvement of diabetes as remission
In several studies in the Western contries remission was confimed in patients who achieved significant weight loss with a daily intake of less than 800 kcal consisting of powder with high protein ingredients When 11 patients with the disease were given only 600 kcal daily for 8 weeks fasting blood glucose significantly decreased within 7 days Diabetologia 2011 54 2506-14 In a follow-up study dietary intervention for 8 weeks was applied to 30 patients about 40 of the patients showed remission of diabetes Diabetes Care 2016 39 158-65
Based on this small study a primary care-based research group in the United Kingdom recruited obese diabetic patients from private clinics across the country and evaluated the diabetic remission effect of a very-low caloric diet in a total of 306 patients In this study 46 of the intervention group and 4 of the non-intervention group reported remission confirming a significant difference in remission rates Patients who achieved more weight loss in the intervention group had higher remission rates with a remission rate of 57 for patients who lost 10 to 15 kg and a remission rate of 86 for patients who lost more than 15 kg Lancet 2018 391 541-51
On the other hand in Korea a study has been conducted using a Korean traditional foods designed by clinical nutritionists for diabetic patients that delivers to home When continuous blood glucose measurement was performed while the special diet program was provided for 2 weeks mean blood glucose and estimated glycated hemoglobin during the treatment diet period decreased compared to the free food period The effect of the Korean-style diabetic diet was thought to be mainly due to the decrease in blood glucose levels after meals J Korean Diabetes 20202146-54
In previous studies total food replacement for calorie restriction was only attempted in the form of powder In the case of the Korean diet it contains a sufficient amount of dietary fiber and has the advantage of maintaining appropriate clinical nutrition therapy by providing various textures and tastes Therefore the investigators planned a clinical study to induce remission with a low-calorie diet using the Korean diet as a meal replacement therapy for calorie restriction in Korean patients with type 2 diabetes
In several studies in the Western contries remission was confimed in patients who achieved significant weight loss with a daily intake of less than 800 kcal consisting of powder with high protein ingredients When 11 patients with the disease were given only 600 kcal daily for 8 weeks fasting blood glucose significantly decreased within 7 days Diabetologia 2011 54 2506-14 In a follow-up study dietary intervention for 8 weeks was applied to 30 patients about 40 of the patients showed remission of diabetes Diabetes Care 2016 39 158-65
Based on this small study a primary care-based research group in the United Kingdom recruited obese diabetic patients from private clinics across the country and evaluated the diabetic remission effect of a very-low caloric diet in a total of 306 patients In this study 46 of the intervention group and 4 of the non-intervention group reported remission confirming a significant difference in remission rates Patients who achieved more weight loss in the intervention group had higher remission rates with a remission rate of 57 for patients who lost 10 to 15 kg and a remission rate of 86 for patients who lost more than 15 kg Lancet 2018 391 541-51
On the other hand in Korea a study has been conducted using a Korean traditional foods designed by clinical nutritionists for diabetic patients that delivers to home When continuous blood glucose measurement was performed while the special diet program was provided for 2 weeks mean blood glucose and estimated glycated hemoglobin during the treatment diet period decreased compared to the free food period The effect of the Korean-style diabetic diet was thought to be mainly due to the decrease in blood glucose levels after meals J Korean Diabetes 20202146-54
In previous studies total food replacement for calorie restriction was only attempted in the form of powder In the case of the Korean diet it contains a sufficient amount of dietary fiber and has the advantage of maintaining appropriate clinical nutrition therapy by providing various textures and tastes Therefore the investigators planned a clinical study to induce remission with a low-calorie diet using the Korean diet as a meal replacement therapy for calorie restriction in Korean patients with type 2 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