Methods: An open-label randomized controlled clinical trial was conducted in HIV-infected patients with PreDM. Patients were randomized into 2 groups: metformin group (received metformin) and control group (not received metformin). Patients in both groups were counseled regarding diet control and lifestyle modification and followed for 6 months. The primary endpoint was the development of DM. Fasting plasma glucose (FPG), 2-hr 75-gm oral glucose tolerance test, HbA1c, computer-based homeostatic model assessment index of beta-cell function (HOMA%B) and insulin resistance (HOMA-IR) were analyzed.
Results: 74 patients were enrolled, 37 in each group. Mean age was 49.6 years and 68.9% were males. At baseline, mean CD4 cell count was 570 cells/mm3 and mean body mass index (BMI) was 24.6 kg/M2. Baseline characteristics including age, sex, BMI, waist-hip (W/H) ratio, duration of ART, ART regimen, CD4 cell count and HIV RNA were similar between 2 groups (p >0.05). Mean FPG, 2hPG, HbA1c, HOMA%B and HOMA-IR at baseline were also similar between 2 groups (p >0.05). At 6 months, 1 patient in metformin group and 2 in control group developed DM [risk reduction 2.70%; 95% CI, −9.09% to +15.20%]. Mean HbA1c significantly decreased from baseline only in metformin group. HOMA-IR at 6 months was significantly lower in metformin group (1.086 vs 1.478, p=0.042). However, BMI, W/H ratio, FPG, 2hPG, HbA1c, and HOMA%B at 6 months were not significantly different between 2 groups (p >0.05). No patient had adverse effects that led to discontinuation of metformin. No cardiovascular event was observed in study period.
Conclusion: Metformin appears to improve insulin resistance and prevent progression to DM in HIV-infected patients with PreDM. Further study with longer study period is needed to evaluate long-term benefit of metformin.
S. Sungkanuparph, None
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