Skip to main content
OpenTrials
Completed

NCT Number: NCT06666205

Carbohydrate Quality and Its Impact on Sleep and Depression in Type 2 Diabetes

The aim of this study was to evaluate the effect of carbohydrate quality on sleep quality and depression in patients with Type 2 diabetes. Data were collected from 150 patients with Type 2 diabetes mellitus using a demographic structure questionnaire, the Sleep Quality Scale (SQS), the Depression, Anxiety, and Stress Scale (DASS), and a Food Consumption Frequency Form. The data were analyzed using SPSS 26.

Completed

Looking for future studies?

Notify Me

Key information

About this study

Objective: The aim of this study was to evaluate the effect of carbohydrate quality on sleep quality and depression in patients with Type 2 diabetes.

Method: A total of 150 individuals with Type 2 diabetes were included in the study. A demographic questionnaire, the Sleep Quality Scale (SQS) (where a higher SQS score indicates lower sleep quality), and the Depression Anxiety and Stress Scale were administered to the participants. Additionally, data on the frequency of food consumption for 132 foods were obtained from the participants. To determine the Carbohydrate Quality Index (CQI) score, each of these four components (fiber intake, whole grain ratio, glycemic index, and total carbohydrate ratio) was evaluated on a scale of 1 to 5 points. The score for each component was then calculated, with Q5 indicating the best and Q1 indicating the worst carbohydrate quality. The data were analyzed using SPSS 24 software.

Detailed Description: This study will evaluate carbohydrate quality index ranges (Q1-Q5), sleep quality scale score, depression, stress, anxiety score, body mass index, diabetic age, sleep duration, body weight, daily macro and micro nutrients.

Conclusion: Results will be analyzed and interpreted after data collection is completed, and conclusions will be drawn accordingly.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 19 to 64 years
  • Diagnosed with Type 2 diabetes mellitus
  • Voluntary participation

Exclusion criteria

  • Patients with cancer
  • Pregnant and lactating women
  • Individuals with alcohol or drug addiction
  • Individuals diagnosed with psychiatric or neurological disorders

Treatment and study plan

Primary outcomes

  1. Evaluating carbohydrate quality

    Time frame: Baseline

    A total of 132 food groups obtained from the food consumption frequency questionnaire were analyzed. Intake (g/day) was calculated using the BeBiS program with a global database, taking into account the amount and frequency of food consumed by each participant. Glycemic Index (GI) values were determined using the BeBiS program's global nutrient database, considering the amount and frequency of food consumed by each participant. To determine the Carbohydrate Quality Index (CQI) score, each of these four components (fiber intake, whole grain ratio, glycemic index, and total carbohydrate ratio) was evaluated on a scale of 1 to 5 points. The scores for each component were then calculated, with Q5 indicating the best and Q1 indicating the worst carbohydrate quality.

Secondary outcomes

  1. Calculating sleep quality

    Time frame: Baseline

    The Sleep Quality Scale (SQS) was used to evaluate the sleep quality of individuals diagnosed with Type 2 diabetes mellitus. The scale consists of a total of 8 questions, each with 3 response options. Scores can range from a minimum of 7 to a maximum of 21. As the score obtained from the scale increases, sleep quality decreases. Questions 5 and 6 were reverse-scored, and a total score was calculated.

  2. Depression, anxiety and stress scores

    Time frame: Baseline

    The Depression Scale was used to evaluate the psychological status of patients with Type 2 diabetes during this process. The scale consists of a total of 21 questions, each graded on a scale from normal to very advanced (mild, moderate, severe, advanced). It has three sub-dimensions: depression, anxiety, and stress. As the scores in the subscales increase, levels of depression, anxiety, and stress also increase.

  3. Sociodemographic characteristics (age,)

    Time frame: Baseline

    Sociodemographic characteristics will be assessed using a structured questionnaire developed by the researchers. The questionnaire will include items measuring age, gender, education level, and income status. The results will be presented as numbers and percentages for each characteristic

  4. Body Mass Index (BMI)

    Time frame: Baseline

    Kilograms per square meter (kg/m2)

  5. Body weight

    Time frame: Baseline

    Body weight in kg

  6. Height

    Time frame: Baseline

    Height in cm

Sponsors and collaborators

Lead sponsor

Ankara Yildirim Beyazıt University

Other

Registry information

Official study title

Evaluation of the Effect of Carbohydrate Quality on Sleep Quality and Depression in Patients with Type 2 Diabete

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 30, 2024
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.