Intervention Effect of Canagliflozin on Prediabetes in Patients With HIV.

Sponsor
xiaolong zhao
Study ID
NCT05135039
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Canagliflozin — DRUG
    Canagliflozin 100mg/day/patient
  • Placebo — DRUG
    Placebo 100mg/day/patient

Study Details

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.

Key Dates

Start date
Jan 1, 2022
Status verified
Feb 2022
Primary completion
Jun 30, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
218 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Placebo Comparator: 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.

Primary Outcome Measure

The rate of progression from prediabetes to diabetes one year after the intervention in both groups of subjects. [ Time Frame: one year ]

Central Contacts

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