PreDiabetesPhase 4MetfoNCT03774108
Metformin and Systemic Inflammation in HIV
A Phase 4 study testing Metformin Hydrochloride 850 MG in people with PreDiabetes and HIV-1-infection, run by Hospital Civil de Guadalajara at 1 site in Mexico.
Trial summary
The purposes of this study are to find out if: metformin can be combined with anti-HIV drugs to reduce systemic inflammation measured by the determination of cytokines and other series of serum markers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PreDiabetes, HIV-1-infection
- What is being tested?
- Metformin Hydrochloride 850 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteMexico
- Study dates
- 15 Dec 2018to 8 Jan 2020
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both sexes,
- Age ≥18 years of age
- With a diagnosis of HIV-1 infection,
- That they are receiving TARE for at least 12 months (time necessary to establish a stable reservoir),
- Patients with undetectable viral load (<40 copies / mL) for at least 12 months,
- Have a CD4 + level> 200 cells / μL,
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- That they do not have a diagnosis of co-infection with HCV or HBV,
- Patients who do not have a severe alcohol intake (<21 glasses / week in men and <14 glasses / week in women),
- Patients who do not use drugs during the last 90 days prior to the screening visit, or during the study,
- Who wish to participate voluntarily in the study and give their written consent.
Who cannot join
- Individuals with a known hypersensitivity / allergy to metformin.
- Patients with contraindications to the use of metformin *.
- Individuals who are actively involved in an experimental therapy study or who have received experimental therapy in the last 6 months.
- People suffering from stage IV-V chronic kidney disease, uncontrolled heart failure or active infections.
- Individuals with diabetes mellitus (according to the criteria of the American Diabetes Association *).
- Patients with indication for the use of statins, aspirin or immunomodulators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metformin Administration Effect Over Systemic Inflammation Serum Markers in HIV Positive Prediabetic Patients
The purposes of this study are to find out if: metformin can be combined with anti-HIV drugs to reduce systemic inflammation measured by the determination of cytokines and other series of serum markers. To determine if the concomitant administration of metformin with TARA improves the immune function on the CD4 T cell count and its relation with the CD8 T cells, during the treatment and after its interruption.
To this end, in the present study, patients with prediabetes (who meet the fasting impaired glucose criteria) will be identified and treated with metformin or placebo for 8 weeks, receiving stable TARA and with a CD4 + level> 200 cells / μL.
40 patients from the HIV Unit of the Civil Hospital of Guadalajara "Fray Antonio Alcalde" will be included in this study and the intervention will last 8 weeks.
- Conditions
- PreDiabetes, HIV-1-infection
- Being tested
- Metformin Hydrochloride 850 MG, Placebo
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin Hydrochloride 850 MGDrug
8 weeks tratment with oral metformin
PlaceboOther
8 weeks tratment with oral placebo
| Study group | Role | What they receive |
|---|---|---|
| Metformin Experimental Arm | Experimental | Metformin 850mg/12 hours, oral, 8 weeks Receives: Drug: Metformin Hydrochloride 850 MG |
| Placebo Comparator Arm | Placebo comparator | Placebo pills/12hours, oral, 8 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of proinflammatory cytokines serum levels by Cytometric Bead Array in prediabetic HIV positive patients after 8 weeks treatment with Metformin
Serum levels of proinflammatory cytokines will be quantify by flow cytometry using a Cytometric Bead Array. The cytokine panel to be messured will be as follows:
- IL-1beta
- IFN-alpha2
- IFN-gamma
- TNF-alpha
- MCP-1
- IL-6
- IL-8
- IL-10
- IL-12p70
- IL-17A
- IL-18
- IL-23
- IL-33
These cytokines will be quantify in prediabetic HIV positive patients after 8 weeks treatment with Metformin
Measured: Basal - 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start15 Dec 2018
- Primary completion20 Dec 2019 (estimated)
- Study completion8 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Civil de Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moises Ramos Solano, Hospital Civil de Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774108
- Sponsor's protocol ID
- 114/18
- Acronym
- Metfo
- Status last verified
- Dec 2019
- First submitted
- 10 Dec 2018
- Last updated
- 19 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from participants will be available upon reasonable request
Publications
Slim J, Saling CF. A Review of Management of Inflammation in the HIV Population. Biomed Res Int. 2016;2016:3420638. doi: 10.1155/2016/3420638. Epub 2016 Sep 27.
PubMed 27766258Arafath S, Campbell T, Yusuff J, Sharma R. Prevalence of and Risk Factors for Prediabetes in Patients Infected With HIV. Diabetes Spectr. 2018 May;31(2):139-143. doi: 10.2337/ds17-0009.
PubMed 29773933Nou E, Lo J, Grinspoon SK. Inflammation, immune activation, and cardiovascular disease in HIV. AIDS. 2016 Jun 19;30(10):1495-509. doi: 10.1097/QAD.0000000000001109.
PubMed 27058351Saisho Y. Metformin and Inflammation: Its Potential Beyond Glucose-lowering Effect. Endocr Metab Immune Disord Drug Targets. 2015;15(3):196-205. doi: 10.2174/1871530315666150316124019.
PubMed 25772174
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metformin Administration Effect Over Systemic Inflammation Serum Markers in HIV Positive Prediabetic Patients
- ClinicalTrials.gov ID
- NCT03774108
- Acronym / sponsor ID
- Metfo / 114/18
- Conditions
- PreDiabetes, HIV-1-infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospital Civil de GuadalajaraUniversity, hospital or other
- Study start
- 15 Dec 2018 (actual)
- Primary completion
- 20 Dec 2019 (estimated)
- Study completion
- 8 Jan 2020 (estimated)
- First posted
- 12 Dec 2018 (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 purposes of this study are to find out if: metformin can be combined with anti-HIV drugs to reduce systemic inflammation measured by the determination of cytokines and other series of serum markers. To determine if the concomitant administration of metformin with TARA improves the immune function on the CD4 T cell count and its relation with the CD8 T cells, during the treatment and after its interruption.
To this end, in the present study, patients with prediabetes (who meet the fasting impaired glucose criteria) will be identified and treated with metformin or placebo for 8 weeks, receiving stable TARA and with a CD4 + level> 200 cells / μL.
40 patients from the HIV Unit of the Civil Hospital of Guadalajara "Fray Antonio Alcalde" will be included in this study and the intervention will last 8 weeks.
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 |
|---|---|---|
| Metformin Experimental Arm | Experimental | Drug: Metformin Hydrochloride 850 MGMetformin 850mg/12 hours, oral, 8 weeks |
| Placebo Comparator Arm | Placebo comparator | Other: PlaceboPlacebo pills/12hours, oral, 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Both sexes,
- Age ≥18 years of age
- With a diagnosis of HIV-1 infection,
- That they are receiving TARE for at least 12 months (time necessary to establish a stable reservoir),
- Patients with undetectable viral load (<40 copies / mL) for at least 12 months,
Key exclusion criteria (6 listed)
- Individuals with a known hypersensitivity / allergy to metformin.
- Patients with contraindications to the use of metformin *.
- Individuals who are actively involved in an experimental therapy study or who have received experimental therapy in the last 6 months.
- People suffering from stage IV-V chronic kidney disease, uncontrolled heart failure or active infections.
- Individuals with diabetes mellitus (according to the criteria of the American Diabetes Association *).
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 |
|---|---|---|
| Metformin Hydrochloride 850 MG8 weeks tratment with oral metformin | Drug | Metformin Experimental Arm |
| Placebo8 weeks tratment with oral placebo | Other | Placebo Comparator Arm |
Primary outcome
Quantification of proinflammatory cytokines serum levels by Cytometric Bead Array in prediabetic HIV positive patients after 8 weeks treatment with Metformin
Time frame: Basal - 8 weeks
Serum levels of proinflammatory cytokines will be quantify by flow cytometry using a Cytometric Bead Array. The cytokine panel to be messured will be as follows: * IL-1beta * IFN-alpha2 * IFN-gamma * TNF-alpha * MCP-1 * IL-6 * IL-8 * IL-10 * IL-12p70 * IL-17A * IL-18 * IL-23 * IL-33 These cytokines will be quantify in prediabetic HIV positive patients after 8 weeks treatment with Metformin
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2019.
- Background: PubMed 27766258Slim J, Saling CF. A Review of Management of Inflammation in the HIV Population. Biomed Res Int. 2016;2016:3420638. doi: 10.1155/2016/3420638. Epub 2016 Sep 27.
- Background: PubMed 29773933Arafath S, Campbell T, Yusuff J, Sharma R. Prevalence of and Risk Factors for Prediabetes in Patients Infected With HIV. Diabetes Spectr. 2018 May;31(2):139-143. doi: 10.2337/ds17-0009.
- Background: PubMed 27058351Nou E, Lo J, Grinspoon SK. Inflammation, immune activation, and cardiovascular disease in HIV. AIDS. 2016 Jun 19;30(10):1495-509. doi: 10.1097/QAD.0000000000001109.
- Background: PubMed 25772174Saisho Y. Metformin and Inflammation: Its Potential Beyond Glucose-lowering Effect. Endocr Metab Immune Disord Drug Targets. 2015;15(3):196-205. doi: 10.2174/1871530315666150316124019.
- Individual participant dataSharing planned: Yes. Data from participants will be available upon reasonable request
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin Hydrochloride 850 MG in people with PreDiabetes and HIV-1-infection, run by Hospital Civil de Guadalajara at 1 site in Mexico.
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 10 inclusion and 6 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 19 Dec 2019. 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 Mexico. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of proinflammatory cytokines serum levels by Cytometric Bead Array in prediabetic HIV positive patients after 8 weeks treatment with Metformin (time frame: Basal - 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03774108, which also lists 4 linked publications.
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 19 Dec 2019.