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Intervention Effect of Canagliflozin on Prediabetes in Patients With HIV.

NCT05135039 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2022-03-08

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Canagliflozin

Canagliflozin 100mg/day/patient

DRUG

Placebo

Placebo 100mg/day/patient

Sponsors & Collaborators

  • xiaolong zhao

    lead OTHER

Principal Investigators

  • Xiaolong Zhao, PhD · Shanghai Public Health Clinical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2024-06-30
Completion
2024-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05135039 on ClinicalTrials.gov