Carbohydrate Counting Training in Type 2 Diabetes

Medipol University

Status: Completed

Conditions: Diabetes Mellitus Type 2; Sarcopenia

Treatments: Behavioral: Carbohydrate Counting Training

Study type: Interventional

Funder types: Other

Identifiers

NCT07016958

IMU- SBE-FGT-01

Details and patient eligibility

About

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.

Full 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)

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Training Group

Experimental group

Description:

The training group received advanced carbohydrate counting training in addition to standard medical and medical nutrition therapy.

Treatment:

Behavioral: Carbohydrate Counting Training

Control Group

No Intervention group

Description:

The control group continued standard medical and medical nutrition therapy only.