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临床试验/NCT05688631
NCT05688631已完成不适用

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

Ankara Yildirim Beyazıt University1 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2021年1月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
87
试验地点
1
主要终点
Serum native thiol level

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
30 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Serum native thiol level

时间窗: Baseline (preprandial in the morning)

serum native thiol level in μmol/L

Disulphide/native thiol ratio

时间窗: Baseline (preprandial in the morning)

Disulphide/native thiol ratio X (100 )

Serum disulphide level

时间窗: Baseline (preprandial in the morning)

serum disulphide level in μmol/L

Native thiol/total thiol ratio

时间窗: Baseline (preprandial in the morning)

Native thiol/total thiol ratio X (100 )

Serum total thiol level

时间窗: Baseline (preprandial in the morning)

serum total thiol level in μmol/L

Disulphide/total thiol ratio

时间窗: Baseline (preprandial in the morning)

Disulphide/total thiol ratio X (100 )

Dietary antioxidant capacity

时间窗: 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.

次要结局

  • Ischemia-modified albumin(Baseline (preprandial in the morning))
  • Low-density lipoprotein (LDL) cholesterol(Baseline (preprandial in the morning))
  • Very low-density lipoprotein (VLDL) cholesterol(Baseline (preprandial in the morning))
  • total/high-density lipoprotein (HDL) cholesterol(Baseline (preprandial in the morning))
  • Body weight(Baseline)
  • hemoglobin A1c (HbA1c)(Baseline (preprandial in the morning))
  • non high-density lipoprotein (HDL) cholesterol(Baseline (preprandial in the morning))
  • Fat mass percentage(Baseline)
  • Fat free mass(Baseline)
  • Oxidative balance score(Baseline)
  • C-reactive protein(Baseline (preprandial in the morning))
  • Total body water(Baseline)
  • Dietary antioxidant intake(Baseline)
  • Fasting plasma glucose(Baseline (preprandial in the morning))
  • Total cholesterol(Baseline (preprandial in the morning))
  • High-density lipoprotein (HDL) cholesterol(Baseline (preprandial in the morning))
  • Height(Baseline)
  • Body mass index(Baseline)
  • Triglyceride(Baseline (preprandial in the morning))
  • Fat mass(Baseline)

研究者

发起方
Ankara Yildirim Beyazıt University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rahime Evra KARAKAYA

Principal Investigator

Ankara Yildirim Beyazıt University

研究点 (1)

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