Clinical trial NCT06666205: Carbohydrate Quality and Its Impact on Sleep and Depression in Type 2 Diabetes
Official title: Evaluation of the Effect of Carbohydrate Quality on Sleep Quality and Depression in Patients with Type 2 Diabete
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 DM
Keywords: carbohydrate quality
type 2 diabetes mellitus
sleep quality
depression
stress
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2024-10-30
Enrollment: 150
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Community sample in Ankara, Turkey

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluating carbohydrate quality
timeFrame: Baseline
Secondary outcomes:
measure: Calculating sleep quality
timeFrame: Baseline
measure: Depression, anxiety and stress scores
timeFrame: Baseline
measure: Sociodemographic characteristics (age,)
timeFrame: Baseline
measure: Body Mass Index (BMI)
timeFrame: Baseline
measure: Body weight
timeFrame: Baseline
measure: Height
timeFrame: Baseline
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yıldırım Beyazıt University
Study officials:
References: