| Background: Diabetes is a chronic metabolic disease caused by insufficient insulin secretion,insulin resistance,or weakened insulin action.Among them,type 2 diabetes accounts for more than 90%.Recently,studies have found that antioxidant nutrients(vitamins,trace elements,phytochemicals,etc.)in the diet can effectively remove free radicals,improve the antioxidant capacity of target cells,regulate the energy metabolism homeostasis,and have a very important role in the prevention and treatment of chronic metabolic diseases.Proanthocyanidins are important polyphenolic phytochemicals,which have significant antioxidant activity and can prevent cardiovascular disease,and reduce the risk of colorectal cancer.Vitamin C and Vitamin E are the most common antioxidant nutrients in the diet.However,it has not been reported whether proanthocyanidins,vitamins C and E can synergistically improve the glucose and lipid metabolism in patients with type 2 diabetes.Objective: In this study,we will explore a clinical trial which used grape seed proanthocyanidins extract(GSPE)or(and)vitamin C and E to explore the effects of GSPE or(and)vitamin C and E on glucose and lipid metabolism in patients with type 2 diabetes.The aim is to provide a new dietary nutrition intervention strategy for type 2 diabetes and provide an important experimental basis for the development of related application products.Methods:1.The interventions metarials and daily doses used in this study are:(1)placebo,no procyanidins,vitamins C and E;(2)grape seed extract proanthocyanidins,daily oligomers procyanidolic(OPC)intervention dose was 376 mg;(3)Vitamin C + E,daily intervention doses of vitamin C and E were 66 and 12 mg respectively;(4)Grape seed extract proanthocyanidins combined with vitamin C + E,daily OPC intervention dose was 364 mg,and the vitamin C and E intervention doses were 66 and 12 mg respectively.2.The research subject were new-onset patients with type 2 diabetes.From August to November 2016,newly recruited patients with type 2 diabetes were recruited as volunteers from the medical examination center of the Medical Examination Center of the First Affiliated Hospital of Army Military Medical University.The research subject was determined according to the diagnostic criteria of type 2 diabetes,the inclusion criteria,and the exclusion criteria.3.A randomized,double-blind,factorial design intervention trial was used.Random number table method was used to randomly divide the research subjects into four groups: control group,GSPE group,VC + VE group,and combination group.68 qualified research subjects randomly entered the above test groups.Each group included 17 people.The subjects were given corresponding interventions for 12 weeks.This study was approved for implementation by the ethical review of the Army Military Medical University(Third Military Medical University).All subjects signed an informed consent form.4.At baseline,all subjects recieved questionnaire surveys such as basic information surveys and food frequency questionnaire,and recieved medical examinations.Before and after 12 weeks of intervention,fasting blood-glucose(FBG)levels,hemoglobin A1c(HbA1c)levels,fasting insulin(FINS)levels,and 2-hour postprandial blood glucose(2h-PBG)level,triglyceride(TG),total cholesterol(TC),high density lipoprotein cholesterol(HDL-C)and low density lipoprotein cholesterol(LDL-C)were measured.HOMA-IR(homeostasis model assessment insulin resistance)index were calculated.Parameters of liver function,kidney function and blood routine were tested.5.Statistical analysis: Excel and SPSS 22.0 software were used to establish a database.Paired t test was used to analyze the difference of each index before and after intervention in each group.The main effects of GSPE intervention and VC + VE intervention,and their interaction effects were analyzed by one factor ANCOVA.P <0.05 means statistical difference.Results:1.Basic situation and baseline levelA total of 68 patients with type 2 diabetes were recruited,and 58 of them completed this trial.The weight,height,blood pressure,education level,marriage state,drinking history,smoking history,and family history of diabetes were balanced among the groups.There were no significant differences in the above parameters between the groups(P > 0.05).2.Dietary surveyThe results of the dietary survey showed that the differences in the intake of various types of food,the average daily dietary energy and the intake of nutrients among these groups were not statistically significant(P > 0.05).3.Effects on indicators related to glucose metabolismBefore the intervention,there was no statistically significant difference in the levels of FBG,2h-PBG,HbA1 c,FINS and HOMA-IR among the experimental groups.There was no interaction effect between GSPE intervention and VC + VE intervention on the glucose metabolism related indexes of type 2 diabetes patients.Compared with patients who did not take GSPE(including the control group and the VC + VE group),the levels of FBG,HbA1 c,FINS,and HOMA-IR index of the patients with GSPE intervention(including the GSPE group and the combined group)were significantly reduced by 0.72±0.90 mmol/L ?0.59±0.54%?15.52±16.81?IU/m L and 5.79±6.76 after the intervention(P <0.05),but there was no significant change in PBG level(P > 0.05).Compared with patients who did not take VC + VE(including the control group and the GSPE group),the changes in the above indicators of patients with VC + VE intervention(including the VC + VE group and the combined group)after 12 weeks of intervention were not statistically significant(P > 0.05).The above results showed that 12 weeks of GSPE intervention can significantly improve the levels of glucose metabolism in patients with new-onset type 2 diabetes,while 12 weeks of vitamin C and E interventions have no improvement effect.4.Effects on blood lipids levelsBefore the intervention,there was no statistically significant difference in the levels of TC,TG,HDL-C and LDL-C among the test groups.There was no interaction effect between GSPE intervention and VC + VE intervention on the glucose metabolism related indexes of type 2 diabetes patients.Compared with patients who did not take GSPE(including the control group and the VC + VE group),GSPE intervention patients(including the GSPE group and the combination group)after the intervention,TC and LDL-C levels were significantly decreased by 0.42 ± 0.41 mmol/L and 0.32 ± 0.40 mmol/L(P <0.05),while TG and HDL-C levels had no significant changes(P > 0.05).Compared with patients who did not take VC + VE(including the control group and the GSPE group),the above indicators of patients with VC + VE intervention(including the VC+VE group and the combined group)did not have statistical significance after 12 weeks of intervention(P > 0.05).The above results show that 12 weeks of GSPE intervention can significantly improve the level of lipid metabolism in patients with new-onset type 2 diabetes,while 12 weeks of vitamin C and E interventions have no improvement effect.5.Influence on liver and kidney function and blood routineThere were no significant differences in liver and kidney function and blood routine indexes of patients in each test group before clinical trial intervention.GSPE or(and)vitamin C and E intervention for 12 weeks had no significant effect on the above indexes(P > 0.05).Conclusions:1.Newly diagnosed type 2 diabetes patients were given 364-378 mg of GSPE daily for 12 weeks.Their glucose metabolism level was significantly improved,which was showed as the significantly reductions in the levels of FBG,HbA1 c,FINS,and HOMA-IR index.2.GSPE(364-378 mg/d)intervention for 12 weeks could significantly reduce the levels of TC and LDL-C in patients with new-onset type 2 diabetes,indicating that GSPE intervention can significantly improve patients' lipid metabolism levels.3.Vitamin C(66 mg/d)and E(12 mg/d)intervention for 12 weeks could not improve the glucose and lipid metabolism level of patients with new-onset type 2 diabetes.4.There is no interaction effect between GSPE intervention and vitamin C and E intervention on the improvement of glucose and lipid metabolism in patients with new-onset type 2 diabetes,indicating that the combination intervention of GSPE and vitamin C and E could not synergistically lower blood glucose and lipid metabolism.5.The interventions of GSPE(364-378 mg/d)or(and)vitamin C(66 mg/d)and E(12 mg/d)for 12 weeks have no significant effect on liver and kidney function and blood routine in newly-onset patients with type 2 diabetes,and no obvious adverse effects were reported. |
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