A Pilot Study of Metformin to Reduce Cerebrovascular Dysfunction in Participants With HIV and Metabolic Syndrome.

Launched by UNIVERSITY OF STELLENBOSCH · Oct 4, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at whether a common diabetes medication called metformin can help improve blood vessel health and reduce inflammation in people living with HIV who also have metabolic syndrome. Metabolic syndrome is a group of conditions that can increase the risk of heart disease and diabetes. Since individuals with HIV are more likely to have these issues, researchers want to see if metformin can help protect their brain health by addressing these problems.

To participate in this study, individuals need to be adults over 18 years old, must have been on HIV treatment for at least a year, and should meet certain criteria for metabolic syndrome. Participants will be asked to provide informed consent, meaning they agree to take part in the study with a full understanding of what it involves. Those who join will be monitored throughout the trial, and it’s important to note that there are specific health conditions that would exclude someone from participating, such as severe kidney issues or certain psychiatric disorders. This study is currently recruiting participants, and it offers a chance to contribute to important research that could help improve the health of people living with HIV and metabolic syndrome.

Gender

ALL

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;