3. Results
3.1. Baseline Characteristics
In this study, 61 were included in the intervention, 2 participants withdrew from the trial due to personal reasons, and finally 59 completed the intervention and were included analysis. (Figure 1) The baseline features of hypertensive patients with T2D are shown in Table 2. There were no differences between the intervention and control groups regarding demographic features, lifestyle characteristics ,anthropometric indices, 24-hour urine sodium and potassium values and OBP values. In addition, the use of antihypertensive drugs was not different between groups.
3.2. Urine test result
Analysis of RMANOVA for repeated measures indicated that 24-hour urine Na+(Intervention: -49.29mmol/24h,P <0.001; Control:-27.62mmol/24h, P =0.015; between groups:21.67mmol/24h,P =0.123)and 24-hour urine Cl-(Intervention: -35.50mmol/24h, P =0.002; Control:-26mmol/24h,P =0.017; between groups:9.51 mmol/24h,P =0.514)decreased significantly in both groups after 4-week dietary intervention.However, 24-hour urine Na+(+25.88mmol/24h, P=0.006)and 24-hour urine Cl – (+26.11 mmol/24h, P =0.005 )in the intervention group increased again from the 4th week. The increase of 24-hour urinary K+( P =0.020) and the decrease of Na+ / K+ ratio (P <0.001)were observed in the intervention group, but not in the control group(P >0.05). In addition, the UACR (P =0.017) of two groups decreased from baseline(Table 3).
3.3. Serum test result
Compared with baseline, the changes of Na+, K+, Cl- and Ca2+in serum electrolytes concentration were observed in the intervention group and the control group, and the change trend was the same as that of 24-hour urine electrolytes. There was no significant change in AST(Alanine aminotransferase), ALT(Aspartate aminotransferase), UA(Uric acid) and Creatinine during the study .However, serum lactate and creatinine were significantly lower than baseline(Table 4).
3.4. BP Measurements During the Study
The results of GEE showed that after one week of intervention, the SBP of the intervention group and the control group (intervention group:-12.17 mmHg, 95% CI: -19.72 ~ -4.62, P<0.001; control group:-7.16 mmHg, 95 %CI: -13.53 ~ -0.78, P =0.012) was significantly lower than the baseline. The DBP of the two groups also decreased significantly from baseline after one week of intervention (intervention group: -7.25mmHg, 95%CI: -0.61 ~ -3.89, P<0.001; control group: -5.29mmHg 95%CI: -8.55 ~ -2.04, P <0.001). At the end of the intervention, the SBP of the intervention group decreased by an average of 14.32 mmHg from the baseline (95%CI: -21.80 ~ -6.83,P <0.001), and the DBP was decreased by an average of 6.32 mmHg 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 mmHg from the baseline (95%CI: -18.26 ~ -3.71, P <0.001), and the DBP was decreased by an average of 5.24 mmHg from the baseline (95%CI: -9.23 ~ -1.25, P =0.001). However, from baseline to the end of the intervention, the changes in SBP and DBP were not statistically significant between the intervention group and the control group (SBP: -0.28mmHg, 95%CI: -6.42 ~ 5.86, P=0.929; DBP: -3.32 mmHg, 95%CI: -7.21 ~ 0.56, P=0.093) (Table 5. Table 6).
3.5. Safety
No serious adverse events occurred during the intervention. Other adverse events included: 1 weeks after intervention, 2 patients developed fatigue and dizziness. At the third week of intervention,2 patients developed mild diarrhea.