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Optimizing Metabolic Health in People Living with HIV: A Randomized Controlled Trial of Metformin Versus Lifestyle Modification (MET-HIV Study)

Optimizing Metabolic Health in People Living with HIV: A Randomized Controlled Trial of Metformin Versus Lifestyle Modification (MET-HIV Study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260215013
Enrollment
400
Registered
2026-02-15
Start date
2026-02-03
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prediabetes PLWH HIV Prediabetes Metformin Lifestyle modification

Interventions

Participants will receive lifestyle modification counseling and metformin 500 mg daily at baseline. At 3 months, laboratory assessments including fasting blood glucose, HbA1c, BUN, and creatinine will
Active Comparator Drug,Active Comparator Behavioral
Metformina and Lifestyle modification arm ,Lifestyle modification arm

Sponsors

Nan hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Age between 18 and 70 years at the time of enrollment. 2. Confirmed HIV infection 3.prediabetes defined by HbA1c 5.7 to 6.4 or fasting blood glucose 100 to 125 mg per dL or 2 hour plasma glucose on OGTT 140 to 199 mg per dL. 4. Receiving antiretroviral therapy with a suppressed HIV viral load. 5.Ability and willingness to comply with the study protocol including lifestyle modification and follow up visits.

Exclusion criteria

Exclusion criteria: 1.HIV-infected individuals who are not receiving antiretroviral therapy (ART). 2.Pregnant or breastfeeding women. HIV-infected individuals receiving ART with unsuppressed viral load (defined as HIV-1 RNA above the target level per national guidelines). History of intolerance, contraindication, or significant adverse effects related to metformin use. Inability or unwillingness to comply with the prescribed lifestyle modification or exercise program.

Design outcomes

Primary

MeasureTime frame
The primary outcome is HbA1c (%) as a continuous variable assessed longitudinally over 24 months Baseline to 24 months continuous

Secondary

MeasureTime frame
Time to event Time from randomization to diabetes onset up to 24 months

Countries

Thailand

Contacts

Public ContactApinya Chueasuwan

NAN hospital

aa31pin@gmail.com66812977835

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026