Clinical trial NCT07016958: Carbohydrate Counting Training in Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Type 2
Sarcopenia
Keywords: Diabetes
carbohydrate
glycemic control
insulin
sarcopenia
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2025-06-12
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are two groups: training and control group.
Primary purpose: SUPPORTIVE_CARE

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)

Eligibility criteria: Inclusion Criteria:

* A history of type 2 diabetes mellitus
* Using insulin for more than one year
* Being over 18 years old
* Receiving basal and bolus insulin treatment
* Not having received carbohydrate counting training before
* Not receiving treatment with sulfanylurea drugs from oral anti-diabetics.

Exclusion Criteria:

* Being pregnant or breastfeeding or planning a pregnancy during the study period,
* Discontinuing insulin treatment during the study period
* Having active proliferative retinopathy, severe nephropathy, severe or newly diagnosed cardiac disease within 6 months or stage III-IV heart failure,
* Having dementia or psychosis and cognitive impairment,
* Receiving glucocorticoid treatment, being fed enterally or parenterally and receiving nutrition treatment due to another/concomitant disease, having end-stage renal or hepatic/ renal disease (other than proteinuria)
* Having liver disease/microangiopathy diseases
* Having clinical cancer, chronic respiratory disease or amputations,
* Having any disease or condition that would prevent completion of the study.

Primary outcomes:
measure: HbA1c (%)
timeFrame: Baseline, week 12 and week 24
measure: Plasma Glucose Levels
timeFrame: Baseline, week 12 and week 24
measure: Muscle Strength
timeFrame: Baseline, week 12, week 24
measure: Skeletal muscle mass
timeFrame: Baseline, week 12, week 24
measure: Physical performance
timeFrame: Baseline, week 12 and week 24
Secondary outcomes:
measure: Blood lipid levels
timeFrame: Baseline, week 12 and week 24
measure: Hypoglicemia Period
timeFrame: Baseline, week 12 and week 24
measure: Total Insulin Dose
timeFrame: Baseline, week 12 and week 24
measure: Daily Prandial Insulin
timeFrame: Baseline, week 12 and week 24
measure: Daily Basal Insulin
timeFrame: Baseline, week 12 and week 24
measure: Serum C peptide Levels
timeFrame: Baseline
measure: Glomerular filtration rate
timeFrame: Baseline, week 12, week 24
measure: Diastolic and Sistolic Blood Pressure
timeFrame: Baseline, week 12, week 24
measure: Waist circumference
timeFrame: Baseline, week 12 and week 24
measure: Hyperglycemia period
timeFrame: Baseline, week 12 and week 24
measure: Food consumption (energy and nutrients intake)
timeFrame: Baseline, week 12 and week 24
measure: Physical Activity Levels
timeFrame: Baseline, week 12 and week 24
measure: Height
timeFrame: Baseline, week 12 and week 24
measure: Body weight and body composition (fat weight, muscle weight, lean weight)
timeFrame: Baseline, week 12 and week 24
measure: Body Mass Index
timeFrame: Baseline, week 12 and week 24
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Uskudar Diabetes Polyclinic of the Fatih Sultan Mehmet Training and Research Hospital
Study officials:
affiliation: Medipol University
name: Indrani KALKAN, Assoc. Prof.
role: STUDY_DIRECTOR
References: