| BackgroundHypertension and type 2 diabetes are very common in China,and the two diseases often appear together,which brings great harm to the health of the population.Lifestyle interventions,especially dietary interventions,are essential for the prevention and control of the two diseases.ObjectiveThe purpose of this study is to investigate the antihypertensive effect of Chinese modified dietary approaches to stop hypertension(CM-DASH)and 52% low sodium salt in patients with hypertension and type 2 diabetes who regularly took antihypertensive drugs,and to observe the safety and compliance of this diet strategy in the population,so as to provide scientific basis for its popularization and application in Chinese patients with hypertension and type 2 diabetes.MethodsThis study was designed as a randomized controlled single blind trial.Participants with hypertension and type 2 diabetes were recruited in the jurisdiction at the Sihai Community Health Service Center of Nan’an District People’s Hospital in Chongqing from December 2019 to June 2020.After completing the baseline questionnaire and physical examination,participants were randomly allocated to intervention group(CM-DASH diet+ 52% lowsodium salt)or control group(CM-DASH diet+ common salt)for 8 weeks with a simple random method.The present study is divided into 3 phases(2weeks of CM-DASH diet adaptation + 2 weeks of CM-DASH diet feeding+ 4 weeks of CM-DASH diet behavior intervention).Participants were followed up in the hospital once a week to collect the information of blood pressure,blood sugar,drug use,salt use,diet and adverse reactions.At the end of the 4th and 8th week of the intervention,a questionnaire survey and physical examination were conducted again,and a qualitative interview was conducted.ResultsA total of 61 patients with hypertension and type 2 diabetes were recruited.2 patients were lost to follow-up during the intervention period.59 patients completed the intervention and were included in the analysis.At the end of the fourth week of intervention,both the intervention group and the control group had a significant decrease in 24-hour urine sodium(intervention group:-49.29 mmol/24 h,95% CI:-71.99 ～-26.59,P<0.001;control group:-27.62 mmol/24 h,95%CI:-54.69 ～-0.54,P=0.044).At the end of the intervention,the 24-hour urine potassium of the intervention group was compared with baseline(11.50 mmol/24 h,95%CI: 1.32 ～ 21.68,P=0.028)and the fourth week(10.87 mmol/24 h,95%CI: 2.03 ～ 19.71,P=0.018),but the 24-hour urine potassium of the control group did not change significantly(P>0.05).At the end of the intervention,the SBP of the intervention group decreased by an average of 14.32 mm Hg from the baseline(95%CI:-21.80 ～-6.83,P<0.001),and the DBP was decreased by6.32 mm Hg from the baseline(95%CI:-9.55 ～-3.08,P <0.001),the SBP of the control group decreased by an average of 10.98 mm Hg from the baseline(95%CI:-18.26 ～-3.71,P<0.001),and the DBP was decreased by an average of 5.24 mm Hg from the baseline(95%CI:-9.23 ～-1.25,P =0.001).However,from baseline to the end of the intervention,there was no statistically significant difference in the changes of SBP and DBP between the intervention group and the control group(SBP:-0.28 mm Hg,95%CI:-6.42～ 5.86,P=0.929;DBP:-3.32 mm Hg,95%CI:-7.21 ～ 0.56,P=0.093).During the intervention,no serious adverse events occurred,some patients experienced mild symptoms such as dizziness,fatigue,diarrhea,and abdominal pain,and all recovered within a short period of time.During the intervention period,blood electrolytes,blood lactic acid and blood creatinine had slight changes compared with the baseline,but they were all within the reference value range.The other indexes such as liver function and kidney function had no significant change compared with the baseline.During the intervention,the participants had good compliance with the salt and diet used in the trial,and no one was unable to adapt and withdrew from the study.The results of qualitative interview showed that the participants had a high recognition of CM-DASH diet,thought it was beneficial to their health,and were willing to adhere to this diet for a long time.Conclusions52% low sodium salt and CM-DASH diet were used in patients with hypertension and type 2 diabetes.The results showed that it was safe,the patients generally had good compliance,and had significant effect in reducing sodium intake,increasing potassium intake,reducing SBP and DBP.However,there was no significant difference in antihypertensive effect between 52% low sodium salt and common salt,this may be due to the small sample size,short intervention time,more confounding factors in the semi open trial,and the high sodium content of low sodium salt.It is necessary to further expand the sample size and explore the use of formula salt with lower sodium content. |
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