Clinical trial NCT05135039: Intervention Effect of Canagliflozin on Prediabetes in Patients With HIV.
Official title: Intervention Effect of Canagliflozin on Prediabetes in Patients With HIV: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PreDiabetes
Hiv
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2021-11-26
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The rate of progression from prediabetes to diabetes one year after the intervention in both groups of subjects.
timeFrame: one year
Secondary outcomes:
measure: Changes in the amount of insulin and C-peptide produced in the two groups of subjects one year after the intervention.
timeFrame: one year
measure: Changes in the number of CD4 T cells after one year intervention in the two groups.
timeFrame: one year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Intervention Effect of Canagliflozin on Prediabetes in Patients With HIV: A Randomized Controlled Trial.
state: Shanghai
Study officials:
affiliation: Shanghai Public Health Clinical Center
name: Xiaolong Zhao, PhD
role: STUDY_CHAIR
References: