Intervention Effect of Canagliflozin on Prediabetes in Patients With HIV.

NCT05135039 | Unknown

• 1 other identifier: 202140085
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Changes in the amount of insulin and C-peptide produced in the two groups of subjects one year after the intervention.

  one year

• Changes in the number of CD4 T cells after one year intervention in the two groups.

  one year

Study Arms (2)

Lifestyle interventions + Canagliflozin

EXPERIMENTAL

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

Lifestyle interventions + Placebo

PLACEBO COMPARATOR

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

Interventions

Canagliflozin DRUG

Canagliflozin 100mg/day/patient

Lifestyle interventions + Canagliflozin

Placebo DRUG

Placebo 100mg/day/patient

Lifestyle interventions + Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• xiaolong zhao: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Prediabetic State; Acquired Immunodeficiency Syndrome

Interventions

Canagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Xiaolong Zhao, PhD

  Shanghai Public Health Clinical Center

  STUDY CHAIR

Central Study Contacts

Xiaolong Zhao, PhD

CONTACT

+862137990333; xiaolongzhao@163.com

Xinyue Xu, master

CONTACT

+862137990333; xuxy530@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: director

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 26, 2021
• Study Start: January 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: March 8, 2022

Record last verified: 2022-02

Locations

CN (1)