Jie Dong1, Yan-Jun Li2, Rong Xu2, Talat Alp Ikizler3, Hai-Yan Wang2. 1. Renal Division, Department of Medicine, Peking University First Hospital; Institute of Nephrology, Peking University; Key Laboratory of Renal Disease, Ministry of Health; Key Laboratory of Renal Disease, Ministry of Education; Beijing, 100034, China dongjie@medmail.com.cn. 2. Renal Division, Department of Medicine, Peking University First Hospital; Institute of Nephrology, Peking University; Key Laboratory of Renal Disease, Ministry of Health; Key Laboratory of Renal Disease, Ministry of Education; Beijing, 100034, China. 3. Division of Nephrology, Vanderbilt University Medical Center, Nashville, TN, United States Vanderbilt Center for Kidney Disease, Vanderbilt University Medical Center, Nashville, TN, United States.
Abstract
UNLABELLED: ♦ BACKGROUND: A low protein diet supplemented with ketoacids has been shown to improve the metabolic profile, including insulin resistance, in patients with chronic kidney disease (CKD), but whether ketoacids alone exert similar effects is unknown. In this prospective randomized controlled trial, we aimed to evaluate the effects of ketoacid supplementation on insulin resistance, systemic inflammation, oxidative stress and endothelial dysfunction among 100 CKD patients undergoing peritoneal dialysis (PD). ♦ METHODS:Patients from one Chinese PD center were randomly assigned to take ketoacids (12 tablets per day) (n = 50) versus a control group (n = 50) for 6 months in an open-label parallelarm design. Daily protein intake of 0.8 - 1.2 g/kg/d and daily energy intake of 25 - 35 kcal/kg/d was prescribed to both groups. Insulin resistance was evaluated using homeostatic model assessment (HOMA-IR) index as the primary outcome. We assessed systemic inflammation using high-sensitive C-reactive protein (hs-CRP) and interleukin-6 (IL-6), oxidative stress using plasma oxidized low density lipoprotein (oxLDL), adipokines using leptin and adiponectin and endothelial dysfunction using serum soluble intercellular adhesion molecule-1 (sICAM) and soluble vascular adhesion molecule-1 (sVCAM) as secondary outcomes. ♦ RESULTS: There were no significant differences in baseline characteristics between the 2 groups except a slightly higher age in patients assigned to the intervention. A total of 89% of participants completed the 6-month intervention. There was no significant difference in the change of HOMA-IR values from baseline between groups after adjusting for baseline age, gender, body mass index and HOMA-IR. For secondary outcomes, hs-CRP varied significantly between groups (p = 0.02), increasing over time for the control group while remaining stable for the ketoacid group. Similarly, the leptin/adiponectin ratio (LAR) differed between groups (p < 0.001), remaining stable in the ketoacid group but increasing in the control group. ♦ CONCLUSION:Ketoacid therapy administered for 6 months had no effect on HOMA-IR but resulted in improvements in hs-CRP and LAR, suggesting metabolic benefit. Future studies are needed to confirm these results and any potential benefit in vascular health of PD patients.
RCT Entities:
UNLABELLED: ♦ BACKGROUND: A low protein diet supplemented with ketoacids has been shown to improve the metabolic profile, including insulin resistance, in patients with chronic kidney disease (CKD), but whether ketoacids alone exert similar effects is unknown. In this prospective randomized controlled trial, we aimed to evaluate the effects of ketoacid supplementation on insulin resistance, systemic inflammation, oxidative stress and endothelial dysfunction among 100 CKDpatients undergoing peritoneal dialysis (PD). ♦ METHODS:Patients from one Chinese PD center were randomly assigned to take ketoacids (12 tablets per day) (n = 50) versus a control group (n = 50) for 6 months in an open-label parallelarm design. Daily protein intake of 0.8 - 1.2 g/kg/d and daily energy intake of 25 - 35 kcal/kg/d was prescribed to both groups. Insulin resistance was evaluated using homeostatic model assessment (HOMA-IR) index as the primary outcome. We assessed systemic inflammation using high-sensitive C-reactive protein (hs-CRP) and interleukin-6 (IL-6), oxidative stress using plasma oxidized low density lipoprotein (oxLDL), adipokines using leptin and adiponectin and endothelial dysfunction using serum soluble intercellular adhesion molecule-1 (sICAM) and soluble vascular adhesion molecule-1 (sVCAM) as secondary outcomes. ♦ RESULTS: There were no significant differences in baseline characteristics between the 2 groups except a slightly higher age in patients assigned to the intervention. A total of 89% of participants completed the 6-month intervention. There was no significant difference in the change of HOMA-IR values from baseline between groups after adjusting for baseline age, gender, body mass index and HOMA-IR. For secondary outcomes, hs-CRP varied significantly between groups (p = 0.02), increasing over time for the control group while remaining stable for the ketoacid group. Similarly, the leptin/adiponectin ratio (LAR) differed between groups (p < 0.001), remaining stable in the ketoacid group but increasing in the control group. ♦ CONCLUSION:Ketoacid therapy administered for 6 months had no effect on HOMA-IR but resulted in improvements in hs-CRP and LAR, suggesting metabolic benefit. Future studies are needed to confirm these results and any potential benefit in vascular health of PDpatients.
Authors: Denis Fouque; Jing Chen; Wei Chen; Liliana Garneata; S J Hwang; Kamyar Kalantar-Zadeh; Joel D Kopple; William E Mitch; Giorgina Piccoli; Vladimir Teplan; Philippe Chauveau Journal: BMC Nephrol Date: 2016-07-07 Impact factor: 2.388