Effect of denosumab on glucose metabolism in postmenopausal osteoporotic women with prediabetes: a study protocol for a 12-month multicenter, open-label, randomized controlled trial.

BACKGROUND: Participants with prediabetes are at a high risk of developing type 2 diabetes (T2D). Recent studies have suggested that blocking the receptor activator of nuclear factor-κB ligand (RANKL) may improve glucose metabolism and delay the development of T2D. However, the effect of denosumab, a fully human monoclonal antibody that inhibits RANKL, on glycemic parameters in the prediabetes population is uncertain. We aim to examine the effect of denosumab on glucose metabolism in postmenopausal women with osteoporosis and prediabetes. METHODS: This is a 12-month multicenter, open-label, randomized controlled trial involving postmenopausal women who have been diagnosed with both osteoporosis and prediabetes. Osteoporosis is defined by the World Health Organization (WHO) as a bone mineral density T score of ≤ - 2.5, as measured by dual-energy X-ray absorptiometry (DXA). Prediabetes is defined as (i) a fasting plasma glucose level of 100-125 mg/dL, (ii) a 2-hour plasma glucose level of 140-199 mg/dL, or (iii) a glycosylated hemoglobin A1c (HbA1c) level of 5.7-6.4%. A total of 346 eligible subjects will be randomly assigned in a 1:1 ratio to receive either subcutaneous denosumab 60 mg every 6 months or oral alendronate 70 mg every week for 12 months. The primary outcome is the change in HbA1c levels from baseline to 12 months. Secondary outcomes include changes in fasting and 2-hour blood glucose levels, serum insulin levels, C-peptide levels, and insulin sensitivity from baseline to 12 months, and the incidence of T2D at the end of the study. Follow-up visits will be scheduled at 3, 6, 9, and 12 months. DISCUSSION: This study aims to provide evidence on the efficacy of denosumab on glucose metabolism in postmenopausal women with osteoporosis and prediabetes. The results derived from this clinical trial may provide insight into the potential of denosumab in preventing T2D in high-risk populations. TRIAL REGISTRATION: This study had been registered in the Chinese Clinical Trials Registry. REGISTRATION NUMBER: ChiCTR2300070789 on April 23, 2023. https://www.chictr.org.cn .

[Moxibustion on mental disorder in close contacts of coronavirus disease 2019: a randomized controlled trial].

OBJECTIVE: To observe the effect of moxibustion combined with Daiwenjiu plaster on mental disorder and self rating symptoms in close contacts of coronavirus disease 2019 (COVID-19) during quarantine. METHODS: A total of 240 close contacts of COVID-19 were randomized into an observation group (120 cases, 18 cases dropped off) and a control group (120 cases, 58 cases dropped off). Conventional observation was adopted in the control group. Moxibustion combined with Daiwenjiu plaster was given in the observation group, moxibustion was applied at Zusanli (ST 36), Hegu (LI 4) and Shenque (CV 8), 10 min each acupoint, once a day; Daiwenjiu plaster was applied at Dazhui (GV 14) and Feishu (BL 13) for 3 to 6 h each time, once every 2 days, the treatment was required for 2 weeks. Before and after treatment and in the follow-up of 2 weeks after treatment, self-reporting questionnaire 20 (SRQ-20), self-rating anxiety scale (SAS) scores and self rating symptoms were evaluated in the two groups. RESULTS: In the follow-up, SRQ-20 score was decreased compared before treatment (P<0.01), SAS score was decreased compared before and after treatment (P<0.01, P<0.05) in the observation group. After treatment and in the follow-up, SRQ-20 scores in the observation group were lower than those in the control group (P<0.05, P<0.01). After treatment, the case proportion of fatigue in the observation group was higher than that in the control group (P<0.05). In the follow-up, the case proportion of tension was lower than that in the control group (P<0.05). CONCLUSION: Moxibustion combined with Daiwenjiu plaster can effectively improve the mental disorder in close contacts of COVID-19.