Dietary Antioxidants and Thiol Disulfide Homeostasis in T2DM

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Dietary Antioxidant Intake and Thiol Disulfide Homeostasis Relationship in Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05688631
• Other study ID #: AnkaraYBU-KARAKAYA001
• Status: Completed
• Start date: January 3, 2021
• Est. completion date: April 20, 2021

Study information

• Verified date: January 2023
• Source: Ankara Yildirim Beyazit University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: April 20, 2021
• Est. primary completion date: March 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

Inclusion Criteria (for case group):

• 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

Inclusion Criteria (for control group):

• Body mass index (BMI) <30 kg/m^2

Exclusion Criteria (for case group):

• Receiving insulin therapy

• Developing diabetes-specific complications

• Smoking tobacco

• Consuming alcohol

• Having end-stage chronic renal failure

• Receiving chemotherapy and/or radiotherapy

• Being in menopause, pregnant and/or lactation period

• Using antioxidant vitamin and mineral supplements

Exclusion Criteria (for control group):

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• Dietary antioxidant intake
Decreased intake of dietary antioxidant is associated with decreased thiol disulfide homeostasis parameters in diabetic and healthy participants.

Locations

Country	Name	City	State
Turkey	Ankara Yildirim Beyazit University	Ankara

Sponsors (2)

Lead Sponsor	Collaborator
Ankara Yildirim Beyazit University	Baskent University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum native thiol level	serum native thiol level in µmol/L	Baseline (preprandial in the morning)
Primary	Serum disulphide level	serum disulphide level in µmol/L	Baseline (preprandial in the morning)
Primary	Serum total thiol level	serum total thiol level in µmol/L	Baseline (preprandial in the morning)
Primary	Disulphide/native thiol ratio	Disulphide/native thiol ratio X (100 )	Baseline (preprandial in the morning)
Primary	Disulphide/total thiol ratio	Disulphide/total thiol ratio X (100 )	Baseline (preprandial in the morning)
Primary	Native thiol/total thiol ratio	Native thiol/total thiol ratio X (100 )	Baseline (preprandial in the morning)
Primary	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.	Baseline
Secondary	Ischemia-modified albumin	ischaemia-modified albumin in ABSU	Baseline (preprandial in the morning)
Secondary	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.	Baseline
Secondary	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.	Baseline
Secondary	Fasting plasma glucose	Fasting plasma glucose in mg/dL	Baseline (preprandial in the morning)
Secondary	hemoglobin A1c (HbA1c)	hemoglobin A1c (HbA1c) in %	Baseline (preprandial in the morning)
Secondary	Total cholesterol	Total cholesterol in mg/dL	Baseline (preprandial in the morning)
Secondary	Low-density lipoprotein (LDL) cholesterol	Low-density lipoprotein (LDL) cholesterol in mg/dL	Baseline (preprandial in the morning)
Secondary	High-density lipoprotein (HDL) cholesterol	High-density lipoprotein (HDL) cholesterol in mg/dL	Baseline (preprandial in the morning)
Secondary	Very low-density lipoprotein (VLDL) cholesterol	Very low-density lipoprotein (VLDL) cholesterol in mg/dL	Baseline (preprandial in the morning)
Secondary	non high-density lipoprotein (HDL) cholesterol	non high-density lipoprotein (HDL) cholesterol in mg/dL	Baseline (preprandial in the morning)
Secondary	total/high-density lipoprotein (HDL) cholesterol	total/high-density lipoprotein (HDL) cholesterol ratio	Baseline (preprandial in the morning)
Secondary	Triglyceride	Triglyceride in mg/dL	Baseline (preprandial in the morning)
Secondary	C-reactive protein	C-reactive protein in mg/dL	Baseline (preprandial in the morning)
Secondary	Body weight	Body weight in kg	Baseline
Secondary	Height	Height in meters	Baseline
Secondary	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.	Baseline
Secondary	Fat mass	Fat mass in kg	Baseline
Secondary	Fat mass percentage	Fat mass percentage in %	Baseline
Secondary	Fat free mass	Fat free mass in kg	Baseline
Secondary	Total body water	Total body water in kg	Baseline