A multi-center, randomized, double-blinded, parallel, placebo-controlled study to assess the efficacy and safety of Shenqisuxin granule in complex coronary artery disease after PCI: Study protocol.

Introduction: The Shenqisuxin granule (SQSX), a novel Chinese herbal formula, has the effect of preventing in-stent restenosis and improving angiogenesis. We intend to evaluate the efficacy and safety of SQSX to provide a possible therapeutic strategy for complex coronary artery disease (CCAD) after percutaneous coronary intervention (PCI). Methods/design: The study is a multi-center, randomized, double-blinded, parallel, placebo-controlled trial. A total of 120 participants will be randomized 1:1 into the intervention group and the control group. Based on standardized treatment, the intervention group and control group will receive SQSX and placebo for 2 months, respectively. The primary outcomes, metabolic equivalents (METS) and peak oxygen uptake (Peak VO2), and the secondary outcomes, including other indicators of cardiorespiratory fitness (CRF), the European Quality of Life Questionnaire (EQ-5D-5L), the Seattle Angina Scale (SAQ), etc., will be assessed at baseline and 2 months ± 3 days. In addition, the survey scales will also be tested at 1 month ± 3 days. Trimethylamine N-oxide (TMAO), high-sensitivity C-reactive protein (hs-CRP), and gut microbiota features will be assessed at baseline and 2 months ± 3 days to probe possible mechanism. The major adverse cardiac and cerebrovascular events (MACCE) and bleeding events will be monitored until the 12-month follow-up. Discussion: This study is launched to assess the efficacy and safety of SQSX in CCAD after PCI and probe the possible mechanism. Clinical trial registration: China Clinical Trial Registry, ChiCTR2200060979, Registered on June 14, 2022.

A low glycemic index staple diet reduces postprandial glucose values in Asian women with gestational diabetes mellitus.

BACKGROUND: A low glycemic index (GI) diet is beneficial for glucose control in patients with diabetes mellitus. This study aimed to investigate the influence of a low-GI diet on postprandial glucose levels in women with gestational diabetes mellitus (GDM). METHODS: Pregnant women with GDM were randomized to receive a normal diabetic control diet or a low-GI staple diet for 5 days. A low-GI staple food was used to replace rice in lunch and dinner for the low-GI staple diet group, whereas the total energy and carbohydrate levels remained equal in both groups. Fasting and postprandial glucose levels were determined daily. RESULTS: A total of 140 pregnant women with GDM were included in the study, including 66 in the low-GI staple diet group and 74 in the normal diabetic diet control group. No differences existed in baseline characteristics between the 2 groups (all P > 0.05). After dietary intervention, glucose levels were significantly reduced in the low-GI staple diet group (all P < 0.01) and the control group (all P < 0.008). Postintervention glucose values after breakfast, lunch, and dinner were significantly reduced in the treatment group compared with those in the control group (all P < 0.05). The percentage changes from baseline of all glucose values were significantly greater in the treatment group than in the control group (all P < 0.05). CONCLUSIONS: A low-GI staple diet significantly reduces postprandial glucose levels in women with GDM.