NCT05135039

Intervention Effect of Canagliflozin on Prediabetes in Patients With HIV.

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 218 (estimated)
• Sponsor: xiaolong zhao · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

• PreDiabetes
• Hiv

Interventions

Type	Name	Description
DRUG	Canagliflozin	Canagliflozin 100mg/day/patient
DRUG	Placebo	Placebo 100mg/day/patient

Timeline

• Start date: 2022-01-01
• Primary completion: 2024-06-30
• Completion: 2024-12-31
• First posted: 2021-11-26
• Last updated: 2022-03-08

Locations

1 site across 1 country: China