Type 2 DMNCT06666205
Carbohydrate Quality and Its Impact on Sleep and Depression in Type 2 Diabetes
An observational study of Type 2 DM, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 64 years
- Conditions the study is for
- Type 2 DM
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2023to 15 Jun 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Community sample in Ankara, Turkey
Who may be able to join
- Patients aged 19 to 64 years
- Diagnosed with Type 2 diabetes mellitus
- Voluntary participation
Who cannot join
- Patients with cancer
- Pregnant and lactating women
- Individuals with alcohol or drug addiction
- Individuals diagnosed with psychiatric or neurological disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Yıldırım Beyazıt University
Ankara, 06760
About this study
Official title: Evaluation of the Effect of Carbohydrate Quality on Sleep Quality and Depression in Patients with Type 2 Diabete
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.
Read the 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.
- Conditions
- Type 2 DM
- Keywords
- carbohydrate quality, type 2 diabetes mellitus, sleep quality, depression, stress
- Medical subject headings
- Diabetes Mellitus, Type 2, Sleep Initiation and Maintenance Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (6)
Calculating sleep quality
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.
Measured: Baseline
Depression, anxiety and stress scores
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.
Measured: Baseline
Sociodemographic characteristics (age,)
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
Measured: Baseline
Body Mass Index (BMI)
Kilograms per square meter (kg/m2)
Measured: Baseline
Body weight
Body weight in kg
Measured: Baseline
Height
Height in cm
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start1 Apr 2023
- Primary completion25 Feb 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DMStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Elibol, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06666205
- Sponsor's protocol ID
- AYBUELİBOL002
- Status last verified
- Oct 2024
- First submitted
- 22 Oct 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Carbohydrate Quality on Sleep Quality and Depression in Patients with Type 2 Diabete
- ClinicalTrials.gov ID
- NCT06666205
- Acronym / sponsor ID
- AYBUELİBOL002
- Conditions
- Type 2 DM
- Keywords
- carbohydrate quality, type 2 diabetes mellitus, sleep quality, depression, stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 25 Feb 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 30 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Community sample in Ankara, Turkey
Key inclusion criteria (3 listed)
- Patients aged 19 to 64 years
- Diagnosed with Type 2 diabetes mellitus
- Voluntary participation
Key exclusion criteria (4 listed)
- Patients with cancer
- Pregnant and lactating women
- Individuals with alcohol or drug addiction
- Individuals diagnosed with psychiatric or neurological disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
Calculating sleep quality
Time frame: Baseline
Depression, anxiety and stress scores
Time frame: Baseline
Sociodemographic characteristics (age,)
Time frame: Baseline
Body Mass Index (BMI)
Time frame: Baseline
Body weight
Time frame: Baseline
Height
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 DM, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluating carbohydrate quality (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.