ABSTRACT
CONTEXT: Acetyl-l-carnitine (ALC), a mitochondrial carrier involved in lipid oxidation and glucose metabolism, decreased systolic blood pressure (SBP), and ameliorated insulin sensitivity in hypertensive nondiabetic subjects at high cardiovascular risk. OBJECTIVE: To assess the effects of ALC on SBP and glycemic and lipid control in patients with hypertension, type 2 diabetes mellitus (T2D), and dyslipidemia on background statin therapy. DESIGN: After 4-week run-in period and stratification according to previous statin therapy, patients were randomized to 6-month, double-blind treatment with ALC or placebo added-on simvastatin. SETTING: Five diabetology units and one clinical research center in Italy. PATIENTS: Two hundred twenty-nine patients with hypertension and dyslipidemic T2D >40 years with stable background antihypertensive, hypoglycemic, and statin therapy and serum creatinine <1.5 mg/dL. INTERVENTIONS: Oral ALC 1000 mg or placebo twice daily on top of stable simvastatin therapy. OUTCOME AND MEASURES: Primary outcome was SBP. Secondary outcomes included lipid and glycemic profiles. Total-body glucose disposal rate and glomerular filtration rate were measured in subgroups by hyperinsulinemic-euglycemic clamp and iohexol plasma clearance, respectively. RESULTS: SBP did not significantly change after 6-month treatment with ALC compared with placebo (-2.09 mm Hg vs -3.57 mm Hg, P = 0.9539). Serum cholesterol, triglycerides, and lipoprotein(a), as well as blood glucose, glycated hemoglobin, fasting insulin levels, homeostatic model assessment of insulin resistance index, glucose disposal rate, and glomerular filtration rate did not significantly differ between treatments. Adverse events were comparable between groups. CONCLUSIONS: Six-month oral ALC supplementation did not affect blood pressure, lipid and glycemic control, insulin sensitivity and kidney function in hypertensive normoalbuminuric and microalbuminuric T2D patients on background statin therapy.
ABSTRACT
BACKGROUND: In developing countries, accessibility to specialists, and physician to patient contact time is limited. In Thailand, A unique community health service is provided by subdistrict health care officers and Village Health Volunteers (VHVs). If the personnel were trained on proper chronic kidney disease (CKD) care, CKD progression would be delayed. METHODS/DESIGN: We conducted a community-based, cluster randomized controlled trial at Kamphaeng Phet Province, located about 400 kilometers north of Bangkok. Two out of eleven districts of the province were randomly selected. Approximatly 500 stage 3-4 CKD patients from 2 districts were enrolled. Patients in both groups will be treated with standard guidelines. The patients in intervention group were provided the additional treatments by multidisciplinary team in conjunction with community CKD care network (subdistrict health care officers and VHVs) which will provide group counseling during each hospital visit and quarterly home visits to monitor dietary protein and sodium intake, blood pressure measurement and drug compliance. Duration of the study is 2 years. The primary outcome is the difference of rate of eGFR decline. The secondary outcomes are laboratory parameters and incidence of clinical endpoints such as mortality rate and cardiovascular events, end-stage renal disease (ESRD), etc. DISCUSSION: Insights of this study may set forth a new standard of community-based CKD care. TRIAL REGISTRATION: NCT01978951.
