Using Metformin to Improve Blood Vessel Health in People with HIV and Metabolic Syndrome

Study of Metformin to Reduce Cerebrovascular Dysfunction in South African Patients With HIV and Metabolic syndRome: a Pilot Trial.

This study is testing if metformin can help improve blood vessel health in adults with HIV and metabolic syndrome to reduce their risk of cognitive decline.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Stellenbosch (Academic / other)
• Drugs / interventions: cART
• Locations: 1 site (Cape Town, Western Cape)
• Trial ID: NCT05571319 on ClinicalTrials.gov

What this trial studies

This pilot study investigates the effects of metformin, a medication commonly used for type 2 diabetes, on cerebrovascular dysfunction in individuals living with HIV who also have metabolic syndrome. The study aims to address the increased risk of vascular damage and inflammation associated with metabolic syndrome, which can lead to cognitive decline and dementia. Participants will be adults over 18 years old who have been on antiretroviral therapy for at least 12 months and meet specific criteria for metabolic syndrome. The study will be conducted at the Gugulethu Research Site in Cape Town, South Africa.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 years old who are HIV-positive, on stable antiretroviral therapy, and diagnosed with metabolic syndrome.

Not a fit: Patients with type 1 or type 2 diabetes, significant renal impairment, or those currently treated with metformin will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new therapeutic approach to reduce cerebrovascular dysfunction and improve cognitive health in people living with HIV and metabolic syndrome.

How similar studies have performed: While there is emerging data on the relationship between metabolic syndrome and cerebrovascular health in HIV-positive individuals, this specific approach using metformin is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* Adult (\>18 years);
* HIV+ on antiretroviral therapy for at least 12 months prior to study entry;
* Viral load ≤50 copies/mL;
* Able to provide informed consent;
* Metabolic syndrome as per the harmonized criteria;
* Women of child-bearing potential willing to use adequate contraception (defined as either an intra-uterine contraceptive device or hormonal contraceptive);

Exclusion Criteria:

* Treated with metformin as part of care;
* History of drug or alcohol abuse within 3 months before screening;
* Known neurosyphilis;
* Known vitamin B12 deficiency;
* Known neuropsychiatric disorders or serious psychiatric symptoms;
* Significant head trauma with imaging structural abnormalities;
* Renal impairment (estimated glomerular filtration \< 60 mL/min/1.73m2);
* Type I or type II diabetes (fasting plasma glucose \>7mmol/L and/or HbA1c \>6.5%);
* Hypersensitivity to metformin;
* Any contraindication or special precaution in the metformin package insert which may put the participant at a safety risk;
* Cationic drugs (as listed in the metformin package insert) that may increase metformin concentrations significantly;
* Claustrophobia, metal implants or any other condition that prevents performing MR scan;
* Pregnant / breastfeeding;

Where this trial is running

Cape Town, Western Cape

• Desmond Tutu Health Foundation: Gugulethu Research Site — Cape Town, Western Cape, South Africa (Recruiting)

Study contacts

• Principal investigator: Eric Decloedt, MBChB, PhD — University of Stellenbosch
• Study coordinator: Eric Decloedt, MBChB, PhD

Conditions Metabolic Syndrome; HIV Seropositivity; pilot open label trial; cerebrovascular dysfunction; endothelial function