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.