Intervention Effect of Canagliflozin on Prediabetes in Patients With HIV.

Study Overview
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Brief Summary
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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.

Official Title
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Intervention Effect of Canagliflozin on Prediabetes in Patients With HIV: A Randomized Controlled Trial.

Conditions
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PreDiabetes, Hiv

Intervention / Treatment
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* Drug: Canagliflozin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle interventions + Canagliflozin<br>Subjects were instructed on diet and exercise and advised to make lifestyle changes while they were given daily oral doses of canagliflozin 100mg. | Drug: Canagliflozin<br>* Canagliflozin 100mg/day/patient<br>|
| Placebo Comparator: Lifestyle interventions + Placebo<br>Subjects were instructed on diet and exercise and advised to make lifestyle changes while they were given daily oral doses of placebo 100mg. | Drug: Placebo<br>* Placebo 100mg/day/patient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of progression from prediabetes to diabetes one year after the intervention in both groups of subjects. | The rate of progression from prediabetes to diabetes one year after the intervention in both groups of subjects. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the amount of insulin and C-peptide produced in the two groups of subjects one year after the intervention. | To investigate the effect of canagliflozin on islet cells, the changes in the amount of insulin and C-peptide produced in two groups of subjects after one year of intervention were examined. | one year | 
| Changes in the number of CD4 T cells after one year intervention in the two groups. | To investigate whether canagliflozin affects immunity in HIV patients, detect number of CD4T cell changes one year after the intervention in both groups of subjects. | one year |