Intervention Effect of Canagliflozin on Prediabetes in Patients With HIV.

Hiv Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05135039
• Other study ID #: 202140085
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2022
• Source: Huashan Hospital
• Contact: Xiaolong Zhao, PhD
• Phone: +862137990333
• Email: xiaolongzhao[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 218
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Intolerance
• Hiv
• PreDiabetes
• Prediabetic State

Intervention

Drug:
• Canagliflozin
Canagliflozin 100mg/day/patient
• Placebo
Placebo 100mg/day/patient

Locations

Country	Name	City	State
China	Intervention Effect of Canagliflozin on Prediabetes in Patients With HIV: A Randomized Controlled Trial.	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
xiaolong zhao

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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