Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2026-01-01 @ 10:27 PM
Study NCT ID:
NCT07016958
Status:
COMPLETED
Last Update Posted:
2025-06-12
First Post:
2025-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carbohydrate Counting Training in Type 2 Diabetes
Sponsor:
Medipol University
Organization:
Study Overview
Official Title:
Effects of Carbohydrate Counting Training Versus Standard Nutritional and Medical Therapy on Glycemic Control and Sarcopenia in Type 2 Diabetes: A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2025-06
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 aimed to evaluate the efficacy of carbohydrate counting in individuals with type 2 diabetes receiving intensive insulin therapy. In addition, the sarcopenia status in this patient group and the effect of carbohydrate counting on sarcopenia were also evaluated.
Detailed Description:
Participants with type 2 diabetes receiving intensive insulin treatment were randomized and divided into 2 groups: education and control groups. Participants in the control group continued their standard medical and medical nutrition treatments. Participants in the training group received advanced carbohydrate counting training consisting of 3 sessions in addition to standard medical and medical nutrition therapy. The measurements of the participants in the training and control groups were repeated three times at the beginning of the study, in the 12th week and in the 24th week of the study.
A questionnaire form containing sociodemographic information was completed by face-to-face interview method. In addition, biochemical (HbA1c, fasting plasma glucose (FPG), C peptide, total cholesterol, HDL, LDL, triglyceride, estimated glomerular filtration rate) and anthropometric and body composition (weight-height, BMI, fat mass, fat ratio, muscle mass, lean tissue mass, waist circumference), hand grip strength and blood pressure measurements of the patients were taken at the beginning, 12th week and 24th week of the study.
In addition, a 24-hour retrospective food consumption record was applied to evaluate the energy and nutrient intakes. The calculation of the energy, macro and micro-nutrient intakes of the participants was carried out using the Turkish Nutrition Database Ebispro for Windows program (version 7.2)
A questionnaire form containing sociodemographic information was completed by face-to-face interview method. In addition, biochemical (HbA1c, fasting plasma glucose (FPG), C peptide, total cholesterol, HDL, LDL, triglyceride, estimated glomerular filtration rate) and anthropometric and body composition (weight-height, BMI, fat mass, fat ratio, muscle mass, lean tissue mass, waist circumference), hand grip strength and blood pressure measurements of the patients were taken at the beginning, 12th week and 24th week of the study.
In addition, a 24-hour retrospective food consumption record was applied to evaluate the energy and nutrient intakes. The calculation of the energy, macro and micro-nutrient intakes of the participants was carried out using the Turkish Nutrition Database Ebispro for Windows program (version 7.2)
Study Oversight
Has Oversight DMC:
True
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?: