Intervention Effect of Canagliflozin on Prediabetes in Patients With HIV: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 218
- 试验地点
- 1
- 主要终点
- The rate of progression from prediabetes to diabetes one year after the intervention in both groups of subjects.
研究概览
简要总结
The high prevalence of prediabetes in HIV patients is also an outpost event for the further development of diabetes and cardiovascular events, as well as for the prolonged survival of HIV patients with metabolic problems and their complications. Based on the well-established experience in the field of traditional diabetes with prediabetes, the combination of SGLT2 inhibitors can target the pathophysiological mechanisms of HIV-induced metabolic disorders, and the results of a small pilot study of one of the representative drugs, cabergoline, in HIV-combined diabetic patients suggest its efficacy and safety in the treatment of HIV-combined diabetic patients. Combined with the advantages of the concentrated disease resources of HIV patients in the investigator's unit, this study is intended to use a single-center randomized controlled clinical trial design, giving the experimental group drug combined with lifestyle intervention and the control group lifestyle combined with placebo intervention, to verify whether the combination of cabergoline and lifestyle intervention can safely and significantly change the clinical outcome of glucose metabolism, as well as the effect on body weight and pancreatic islet function of patients The study provides top clinical evidence for the treatment of these patients and suggests a new set of interventions for patients with HIV combined with prediabetes. No similar studies have been found to be innovative in the literature search, and the implementation of this study will be of great clinical value.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with HIV infection combined with prediabetes who are not treated with antidiabetic drugs
- •Fasting blood glucose of 6.1-6.9 mmol/L or 2-hour oral glucose tolerance test of 7.8-11.0 mmol/L
- •BMI >24 kg/m2 and no more than 10% weight fluctuation in 3 months
- •HIV-infected patients must be on antiretroviral therapy, no significant symptoms, have HIV RNA below the lower limit of detection for 3 consecutive months, and have CD4 cells greater than 200/uL
排除标准
- •Patients with diagnosed diabetes
- •Those who are unwilling to participate or unable to cooperate
- •The patient has had an acute heart attack or cardiovascular disease in the last three months
- •Positive pancreatic islet autoimmune antibody
- •History of pancreatitis or pancreatic cancer
- •Pregnant or breastfeeding women
- •Liver function aminotransferases greater than 2 times the upper limit of the normal range
- •Patients with previous recurrent urinary tract infections
- •Glomerular filtration rate <45ml/min/1.73m2
- •Other serious co-morbidities
研究组 & 干预措施
Lifestyle interventions + Canagliflozin
Subjects were instructed on diet and exercise and advised to make lifestyle changes while they were given daily oral doses of canagliflozin 100mg.
干预措施: Canagliflozin (Drug)
Lifestyle interventions + Placebo
Subjects were instructed on diet and exercise and advised to make lifestyle changes while they were given daily oral doses of placebo 100mg.
干预措施: Placebo (Drug)
结局指标
主要结局
The rate of progression from prediabetes to diabetes one year after the intervention in both groups of subjects.
时间窗: one year
The rate of progression from prediabetes to diabetes one year after the intervention in both groups of subjects.
次要结局
- Changes in the amount of insulin and C-peptide produced in the two groups of subjects one year after the intervention.(one year)
- Changes in the number of CD4 T cells after one year intervention in the two groups.(one year)
研究者
xiaolong zhao
director
Huashan Hospital