Diabetes Mellitus, Type 2NCT05688631
Dietary Antioxidants and Thiol Disulfide Homeostasis in T2DM
An observational study of Diabetes Mellitus, Type 2 and Antioxidative Stress, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
This observational study was planned to determine the relationship between dietary antioxidant intake and thiol disulfide homeostasis of individuals with type 2 diabetes. One of the current approaches in medical nutrition therapy of diabetes is to increase the consumption of foods with high antioxidant content in… Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Antioxidative Stress
- What is being tested?
- Dietary antioxidant intake
- How many people
- 87 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jan 2021to 20 Apr 2021
- 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 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Participants who applied to Ankara City Hospital Endochronology Polyclinic between January and April 2021.
Who may be able to join
- Diagnosis with type 2 diabetes mellitus
- Diabetes age for a maximum of 5 years
- Body mass index (BMI)<30 kg/m^2
- Received and applied medical nutrition therapy and metformin therapy
- Body mass index (BMI) <30 kg/m^2
Who cannot join
- Receiving insulin therapy
- Developing diabetes-specific complications
- Smoking tobacco
- Consuming alcohol
- Having end-stage chronic renal failure
- Receiving chemotherapy and/or radiotherapy
Show all 16Show fewer
- Being in menopause, pregnant and/or lactation period
- Using antioxidant vitamin and mineral supplements
- Smoking tobacco
- Using alcohol
- Having any chronic disease
- Having end-stage chronic renal failure
- Receiving chemotherapy and/or radiotherapy
- Being in menopausal, pregnant and/or lactation period,
- Using antioxidant vitamin and mineral supplements
- Following any diet program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dietary Antioxidant Intake and Thiol Disulfide Homeostasis Relationship in Type 2 Diabetes Mellitus
This observational study was planned to determine the relationship between dietary antioxidant intake and thiol disulfide homeostasis of individuals with type 2 diabetes. One of the current approaches in medical nutrition therapy of diabetes is to increase the consumption of foods with high antioxidant content in order to strengthen antioxidant defense. Increased dietary antioxidant intake may have both protective and therapeutic effects by reducing the risk of diabetes and preventing complications that may occur. It is known that dynamic thiol disulfide balance can be a good indicator of antioxidant defense in individuals with diabetes, and there are limited studies on this subject.
Read the detailed description
Power analysis was performed to determine the study sample. In order to reveal a moderate to high level effect for each parameter with 80% power and 5% margin of error, it was found appropriate to work with a total of 68 people, 34 of whom were T2DM and 34 of whom were healthy. In order to keep the sample size higher, a total of 87 individuals, including 40 T2DM and 47 healthy individuals, were included in this study. Individuals who agreed to participate in the study gave their informed consent. Anthropometic measurements (body weight and height) were taken by the researcher. BMI values of individuals were calculated with the formula of body weight (kg)/height (m)2 Routine fasting plasma glucose (FPG), hemoglobin A1c (HbA1c), total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, very low-density lipoprotein (VLDL), non-HDL cholesterol, Total/HDL cholesterol ratio, triglyceride (TG), C-reactive protein (CRP) values were analyzed with blood samples taken by the nurse on an 8 hours of fasting in the morning. Dynamic thiol disulfide balance was determined by native thiol, total thiol and disulfide values and oxidized albumin was determined by IMA values. Food consumption records of individuals were taken to determine dietary antioxidant intake and dietary antioxidant capacity. Oxidative balance score was used to evaluate the exposure of individuals to antioxidants and prooxidants. Descriptive statistics for categorical variables are presented as frequency and percentage. The conformity of the numerical variables to the normal distribution was checked using the Shapiro-Wilk Test. The descriptive statistics of numerical variables were given as mean (±) standard deviation for those with normal distribution, and median interquartile range [IQR] values for those without normal distribution. In the comparison of two independent groups; Independent Sample T Test was used if the data provided the assumptions of the parametric tests, the Mann-Whitney U Test was used if the assumptions of the parametric tests were not met, and the Chi-square Test was used for the comparison of two qualitative groups. Examination of the relationships between quantitative variables was determined by the "Pearson Correlation Coefficient" for those with normal distribution and the Spearman Correlation Coefficient for those who did not. In the interpretation of the correlation coefficient, very weak correlation criteria were used if <0.2, weak correlation between 0.2-0.4, moderate correlation between 0.4-0.6, high correlation between 0.6-0.8, and very high correlation if 0.8>. Statistical significance level was considered as α<0.05, α<0.01, α<0.001 in all calculations and interpretations and hypotheses were established as bidirectional. Statistical analysis of the data was performed with SPSS v26 (IBM Inc., Chicago, IL, USA) statistical package program.
- Conditions
- Diabetes Mellitus, Type 2, Antioxidative Stress
- Being tested
- Dietary antioxidant intake
- Keywords
- Diabetes mellitus, Dietary antioxidants, Oxidative stress, Thiol disulfide homeostasis
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary antioxidant intakeOther
Decreased intake of dietary antioxidant is associated with decreased thiol disulfide homeostasis parameters in diabetic and healthy participants.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic participants (case group) | Participants diagnosed with type 2 diabetes mellitus Receives: Other: Dietary antioxidant intake | |
| Healthy participants (control group) | Participants not diagnosed with type 2 diabetes mellitus or any other chronic diseases Receives: Other: Dietary antioxidant intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum native thiol level
serum native thiol level in μmol/L
Measured: Baseline (preprandial in the morning)
Serum disulphide level
serum disulphide level in μmol/L
Measured: Baseline (preprandial in the morning)
Serum total thiol level
serum total thiol level in μmol/L
Measured: Baseline (preprandial in the morning)
Disulphide/native thiol ratio
Disulphide/native thiol ratio X (100 )
Measured: Baseline (preprandial in the morning)
Disulphide/total thiol ratio
Disulphide/total thiol ratio X (100 )
Measured: Baseline (preprandial in the morning)
Native thiol/total thiol ratio
Native thiol/total thiol ratio X (100 )
Measured: Baseline (preprandial in the morning)
Dietary antioxidant capacity
Dietary intake assessed using 3-day dietary records. Participants instructed to record all dietary intake for 3 consecutive days, including 2 weekdays and 1 weekend day. Average value of 3 day nutrients were recorded and analyzed using Nutrition Data Base Ebispro for Windows, Stuttgart, Germany; Turkish Version (BeBiS 8.2), for Research software.
Measured: Baseline
Secondary outcomes (20)
Ischemia-modified albumin
ischaemia-modified albumin in ABSU
Measured: Baseline (preprandial in the morning)
Dietary antioxidant intake
Dietary intake assessed using 3-day dietary records. Participants instructed to record all dietary intake for 3 consecutive days, including 2 weekdays and 1 weekend day. Average value of 3 day nutrients were recorded and analyzed using Nutrition Data Base Ebispro for Windows, Stuttgart, Germany; Turkish Version (BeBiS 8.2), for Research software.
Measured: Baseline
Oxidative balance score
Dietary intake assessed using 3-day dietary records. Participants instructed to record all dietary intake for 3 consecutive days, including 2 weekdays and 1 weekend day. Average value of 3 day nutrients were recorded and analyzed using Nutrition Data Base Ebispro for Windows, Stuttgart, Germany; Turkish Version (BeBiS 8.2), for Research software.
Measured: Baseline
Fasting plasma glucose
Fasting plasma glucose in mg/dL
Measured: Baseline (preprandial in the morning)
hemoglobin A1c (HbA1c)
hemoglobin A1c (HbA1c) in %
Measured: Baseline (preprandial in the morning)
Total cholesterol
Total cholesterol in mg/dL
Measured: Baseline (preprandial in the morning)
Low-density lipoprotein (LDL) cholesterol
Low-density lipoprotein (LDL) cholesterol in mg/dL
Measured: Baseline (preprandial in the morning)
High-density lipoprotein (HDL) cholesterol
High-density lipoprotein (HDL) cholesterol in mg/dL
Measured: Baseline (preprandial in the morning)
Very low-density lipoprotein (VLDL) cholesterol
Very low-density lipoprotein (VLDL) cholesterol in mg/dL
Measured: Baseline (preprandial in the morning)
non high-density lipoprotein (HDL) cholesterol
non high-density lipoprotein (HDL) cholesterol in mg/dL
Measured: Baseline (preprandial in the morning)
total/high-density lipoprotein (HDL) cholesterol
total/high-density lipoprotein (HDL) cholesterol ratio
Measured: Baseline (preprandial in the morning)
Triglyceride
Triglyceride in mg/dL
Measured: Baseline (preprandial in the morning)
C-reactive protein
C-reactive protein in mg/dL
Measured: Baseline (preprandial in the morning)
Body weight
Body weight in kg
Measured: Baseline
Height
Height in meters
Measured: Baseline
Body mass index
Body weight was measured via bioelectrical impedance analysis. Body height was taken by trained researcher in Frankfort Plane via Stadiometer. Weight and height combined to report body mass index in kg/m^2.
Measured: Baseline
Fat mass
Fat mass in kg
Measured: Baseline
Fat mass percentage
Fat mass percentage in %
Measured: Baseline
Fat free mass
Fat free mass in kg
Measured: Baseline
Total body water
Total body water in kg
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start3 Jan 2021
- Primary completion12 Mar 2021
- Study completion20 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Collaborators
- Baskent University
- Responsible party
- Principal investigator, Rahime Evra KARAKAYA, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05688631
- Sponsor's protocol ID
- AnkaraYBU-KARAKAYA001
- Status last verified
- Jan 2023
- First submitted
- 10 Dec 2022
- Last updated
- 18 Jan 2023
- 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 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Antioxidant Intake and Thiol Disulfide Homeostasis Relationship in Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05688631
- Acronym / sponsor ID
- AnkaraYBU-KARAKAYA001
- Conditions
- Diabetes Mellitus, Type 2, Antioxidative Stress
- Keywords
- Diabetes mellitus, Dietary antioxidants, Oxidative stress, Thiol disulfide homeostasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Collaborators
- Baskent University
- Study start
- 3 Jan 2021 (actual)
- Primary completion
- 12 Mar 2021 (actual)
- Study completion
- 20 Apr 2021 (actual)
- First posted
- 18 Jan 2023 (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.
This observational study was planned to determine the relationship between dietary antioxidant intake and thiol disulfide homeostasis of individuals with type 2 diabetes. One of the current approaches in medical nutrition therapy of diabetes is to increase the consumption of foods with high antioxidant content in order to strengthen antioxidant defense. Increased dietary antioxidant intake may have both protective and therapeutic effects by reducing the risk of diabetes and preventing complications that may occur. It is known that dynamic thiol disulfide balance can be a good indicator of antioxidant defense in individuals with diabetes, and there are limited studies on this subject.
Detailed description
Power analysis was performed to determine the study sample. In order to reveal a moderate to high level effect for each parameter with 80% power and 5% margin of error, it was found appropriate to work with a total of 68 people, 34 of whom were T2DM and 34 of whom were healthy. In order to keep the sample size higher, a total of 87 individuals, including 40 T2DM and 47 healthy individuals, were included in this study. Individuals who agreed to participate in the study gave their informed consent. Anthropometic measurements (body weight and height) were taken by the researcher. BMI values of individuals were calculated with the formula of body weight (kg)/height (m)2 Routine fasting plasma glucose (FPG), hemoglobin A1c (HbA1c), total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, very low-density lipoprotein (VLDL), non-HDL cholesterol, Total/HDL cholesterol ratio, triglyceride (TG), C-reactive protein (CRP) values were analyzed with blood samples taken by the nurse on an 8 hours of fasting in the morning. Dynamic thiol disulfide balance was determined by native thiol, total thiol and disulfide values and oxidized albumin was determined by IMA values. Food consumption records of individuals were taken to determine dietary antioxidant intake and dietary antioxidant capacity. Oxidative balance score was used to evaluate the exposure of individuals to antioxidants and prooxidants. Descriptive statistics for categorical variables are presented as frequency and percentage. The conformity of the numerical variables to the normal distribution was checked using the Shapiro-Wilk Test. The descriptive statistics of numerical variables were given as mean (±) standard deviation for those with normal distribution, and median interquartile range [IQR] values for those without normal distribution. In the comparison of two independent groups; Independent Sample T Test was used if the data provided the assumptions of the parametric tests, the Mann-Whitney U Test was used if the assumptions of the parametric tests were not met, and the Chi-square Test was used for the comparison of two qualitative groups. Examination of the relationships between quantitative variables was determined by the "Pearson Correlation Coefficient" for those with normal distribution and the Spearman Correlation Coefficient for those who did not. In the interpretation of the correlation coefficient, very weak correlation criteria were used if <0.2, weak correlation between 0.2-0.4, moderate correlation between 0.4-0.6, high correlation between 0.6-0.8, and very high correlation if 0.8>. Statistical significance level was considered as α<0.05, α<0.01, α<0.001 in all calculations and interpretations and hypotheses were established as bidirectional. Statistical analysis of the data was performed with SPSS v26 (IBM Inc., Chicago, IL, USA) statistical package program.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic participants (case group) | – | Other: Dietary antioxidant intakeParticipants diagnosed with type 2 diabetes mellitus |
| Healthy participants (control group) | – | Other: Dietary antioxidant intakeParticipants not diagnosed with type 2 diabetes mellitus or any other chronic diseases |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants who applied to Ankara City Hospital Endochronology Polyclinic between January and April 2021.
Key inclusion criteria (5 listed)
- Diagnosis with type 2 diabetes mellitus
- Diabetes age for a maximum of 5 years
- Body mass index (BMI)<30 kg/m^2
- Received and applied medical nutrition therapy and metformin therapy
- Body mass index (BMI) <30 kg/m^2
Key exclusion criteria (16 listed)
- Receiving insulin therapy
- Developing diabetes-specific complications
- Smoking tobacco
- Consuming alcohol
- Having end-stage chronic renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary antioxidant intakeDecreased intake of dietary antioxidant is associated with decreased thiol disulfide homeostasis parameters in diabetic and healthy participants. | Other | Diabetic participants (case group), Healthy participants (control group) |
Primary outcome
Serum native thiol level
Time frame: Baseline (preprandial in the morning)
serum native thiol level in μmol/L
Serum disulphide level
Time frame: Baseline (preprandial in the morning)
serum disulphide level in μmol/L
Serum total thiol level
Time frame: Baseline (preprandial in the morning)
serum total thiol level in μmol/L
Disulphide/native thiol ratio
Time frame: Baseline (preprandial in the morning)
Disulphide/native thiol ratio X (100 )
Disulphide/total thiol ratio
Time frame: Baseline (preprandial in the morning)
Disulphide/total thiol ratio X (100 )
Native thiol/total thiol ratio
Time frame: Baseline (preprandial in the morning)
Native thiol/total thiol ratio X (100 )
Dietary antioxidant capacity
Time frame: Baseline
Dietary intake assessed using 3-day dietary records. Participants instructed to record all dietary intake for 3 consecutive days, including 2 weekdays and 1 weekend day. Average value of 3 day nutrients were recorded and analyzed using Nutrition Data Base Ebispro for Windows, Stuttgart, Germany; Turkish Version (BeBiS 8.2), for Research software.
20 secondary outcomes
Ischemia-modified albumin
Time frame: Baseline (preprandial in the morning)
Dietary antioxidant intake
Time frame: Baseline
Oxidative balance score
Time frame: Baseline
Fasting plasma glucose
Time frame: Baseline (preprandial in the morning)
hemoglobin A1c (HbA1c)
Time frame: Baseline (preprandial in the morning)
Total cholesterol
Time frame: Baseline (preprandial in the morning)
Low-density lipoprotein (LDL) cholesterol
Time frame: Baseline (preprandial in the morning)
High-density lipoprotein (HDL) cholesterol
Time frame: Baseline (preprandial in the morning)
Very low-density lipoprotein (VLDL) cholesterol
Time frame: Baseline (preprandial in the morning)
non high-density lipoprotein (HDL) cholesterol
Time frame: Baseline (preprandial in the morning)
total/high-density lipoprotein (HDL) cholesterol
Time frame: Baseline (preprandial in the morning)
Triglyceride
Time frame: Baseline (preprandial in the morning)
C-reactive protein
Time frame: Baseline (preprandial in the morning)
Body weight
Time frame: Baseline
Height
Time frame: Baseline
Body mass index
Time frame: Baseline
Fat mass
Time frame: Baseline
Fat mass percentage
Time frame: Baseline
Fat free mass
Time frame: Baseline
Total body water
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 18 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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 Diabetes Mellitus, Type 2 and Antioxidative Stress, 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 5 inclusion and 16 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 18 Jan 2023. 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?
Serum native thiol level (time frame: Baseline (preprandial in the morning)). The study lists 7 primary outcomes in all. 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 18 Jan 2023.