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

NCT06666205 | Completed

• 1 other identifier: AYBUELİBOL002
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 DM

Keywords

carbohydrate quality; type 2 diabetes mellitus; sleep quality; depression; stress

Outcome Measures

Primary Outcomes (1)

• Evaluating carbohydrate quality

  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.

  Baseline

Secondary Outcomes (6)

• Calculating sleep quality

  Baseline

• Depression, anxiety and stress scores

  Baseline

• Sociodemographic characteristics (age,)

  Baseline

• Body Mass Index (BMI)

  Baseline

• Body weight

  Baseline

Study Arms (1)

Type 2 DM patients

This study focuses on patients with Type 2 diabetes and examines the impact of carbohydrate quality on sleep quality and depression. Participants were assessed using a demographic questionnaire, and their dietary carbohydrate intake was analyzed. Sleep patterns were monitored, and depression levels were measured using validated assessment scales. The study aims to investigate the relationship between carbohydrate quality, sleep health, and depression in this population.

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Community sample in Ankara, Turkey

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Ankara Yıldırım Beyazıt University

Ankara, 06760, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Sleep Initiation and Maintenance Disorders; Depression

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 30, 2024
• Study Start: April 1, 2023
• Primary Completion: February 25, 2024
• Study Completion: June 15, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)