Intervention Effect of Canagliflozin on Prediabetes in Patients With HIV.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

218 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-12-31

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.

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Detailed Description

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Conditions

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PreDiabetes Hiv

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Canagliflozin

Intervention Type DRUG

Canagliflozin 100mg/day/patient

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo 100mg/day/patient

Interventions

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Canagliflozin

Canagliflozin 100mg/day/patient

Intervention Type DRUG

Placebo

Placebo 100mg/day/patient

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No