Intervention Effect of Canagliflozin on Prediabetes in Patients With HIV.

February 19, 2022 updated by: xiaolong zhao

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

218

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Xinyue Xu, master
  • Phone Number: 6261 +862137990333
  • Email: xuxy530@163.com

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Intervention Effect of Canagliflozin on Prediabetes in Patients With HIV: A Randomized Controlled Trial.
        • Contact:
        • Contact:
          • Xinyue Xu, master
          • Phone Number: 6261 +86 21 3799 0333
          • Email: xuxy530@163.com
        • Sub-Investigator:
          • Xinyue Xu, master
        • Principal Investigator:
          • Xiaolong Zhao, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Canagliflozin
Canagliflozin 100mg/day/patient
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.
Drug: Placebo
Placebo 100mg/day/patient

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the amount of insulin and C-peptide produced in the two groups of subjects one year after the intervention.
Time Frame: one year
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
Changes in the number of CD4 T cells after one year intervention in the two groups.
Time Frame: one year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

xiaolong zhao

Investigators

  • Study Chair: Xiaolong Zhao, PhD, Shanghai Public Health Clinical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Anticipated)

June 30, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

October 21, 2021

First Submitted That Met QC Criteria

November 13, 2021

First Posted (Actual)

November 26, 2021

Study Record Updates

Last Update Posted (Actual)

March 8, 2022

Last Update Submitted That Met QC Criteria

February 19, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202140085

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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