PreDiabetesNCT05135039
Intervention Effect of Canagliflozin on Prediabetes in Patients With HIV.
A study testing Canagliflozin in people with PreDiabetes and Hiv, run by xiaolong zhao at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- PreDiabetes, Hiv
- What is being tested?
- Canagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 218 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Intervention Effect of Canagliflozin on Prediabetes in Patients With HIV: A Randomized Controlled Trial.
Shanghai, Shanghai Municipality, 200000
Xiaolong Zhao, PhD, +86 21 3799 0333 ext. 6261, xiaolongzhao@163.com
Xinyue Xu, master, +86 21 3799 0333 ext. 6261, xuxy530@163.com
About this study
Official title: 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.
- Conditions
- PreDiabetes, Hiv
- Being tested
- Canagliflozin, Placebo
- Medical subject headings
- Prediabetic State, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CanagliflozinDrug
Canagliflozin 100mg/day/patient
PlaceboDrug
Placebo 100mg/day/patient
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: one year
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start1 Jan 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- xiaolong zhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, xiaolong zhao, Huashan Hospital
- Investigators
- Xiaolong Zhao, PhD, Study chair, Shanghai Public Health Clinical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05135039
- Sponsor's protocol ID
- 202140085
- Status last verified
- Feb 2022
- First submitted
- 21 Oct 2021
- Last updated
- 8 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Effect of Canagliflozin on Prediabetes in Patients With HIV: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05135039
- Acronym / sponsor ID
- 202140085
- Conditions
- PreDiabetes, Hiv
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- xiaolong zhaoUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle interventions + Canagliflozin | Experimental | Drug: CanagliflozinSubjects were instructed on diet and exercise and advised to make lifestyle changes while they were given daily oral doses of canagliflozin 100mg. |
| Lifestyle interventions + Placebo | Placebo comparator | Drug: PlaceboSubjects were instructed on diet and exercise and advised to make lifestyle changes while they were given daily oral doses of placebo 100mg. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CanagliflozinCanagliflozin 100mg/day/patient | Drug | Lifestyle interventions + Canagliflozin |
| PlaceboPlacebo 100mg/day/patient | Drug | Lifestyle interventions + Placebo |
Primary outcome
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.
2 secondary outcomes
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
Changes in the number of CD4 T cells after one year intervention in the two groups.
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
Related trials for PreDiabetes
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
CGM-Enhanced DPP to Prevent Type 2 Diabetes in Adults With Prediabetes
PreDiabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaolong Zhao, PhD study chair
Shanghai Public Health Clinical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Canagliflozin in people with PreDiabetes and Hiv, run by xiaolong zhao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaolong Zhao, PhD (+862137990333 ext. 6261, xiaolongzhao@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2022.