TY - JOUR
T1 - Therapeutic lifestyle change intervention improved metabolic syndrome criteria and is complementary to amlodipine/atorvastatin
AU - Sallam, Hanaa S.
AU - Tuvdendorj, Demidmaa R.
AU - Jialal, Ishwarlal
AU - Chandalia, Manisha
AU - Abate, Nicola
N1 - Funding Information:
The authors would like to express their gratitude to the study participants for their dedication and time; and to Dr. Peter Snell help with underwater weighing; and Dr. Magdalene Szuszkiewicz-Garcia and Dr. Thanalakshmi Seenivasan, PhD for their assistance in patient recruitment. This study was funded by Pfizer Inc. , and conducted with the support of the Institute for Translational Sciences at the University of Texas Medical Branch , supported in part by a Clinical and Translational Science Award ( UL1 TR001439 ) and Mentored Career Development (KL2) Award ( KL2TR001441 ) from the National Center for Advancing Translational Sciences, National Institutes of Health . The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Appendix A Table A.1 Baseline general characteristics and clinical chemistry parameters for subjects who completed the study. Table A.1 Variables TLC + placebo ( n = 13) TLC + AA ( n = 13) Non-parametric t -test p value for deltas Baseline (BsL) Post-intervention (1 year) Paired t -test p value Baseline (BsL) Post-intervention (1 year) Paired t -test p value Weight (kg) 90(80–106) 97(77–106) 0.1 105(83–123) 102(84–116) 0.2 0.6 BMI 35(31–37) 33(31–37) 0.1 36(31–39) 35(30–38) 0.3 0.5 Body fat (%) 42(33–44) 41(32–44) 0.9 41(36–48) 40(34–45) 0.07 0.1 Hip (cm) 130(113–135) 117(109–119) 0.3 131(124–135) 120(112–125) 0.3 0.5 Waist (cm) 109(97–116) 108(94–114) 0.08 122(105–127) 112(103–126) 0.07 1 Waist/hip ratio 0.89(0.78–0.99) 0.95(0.86–1.06) 0.5 0.98(0.72–1.03) 0.92(0.75–1.07) 0.9 0.7 FBG (mg/dl) 94(93–101) 104(100–115) 0.07 102(98–108) 102(91–107) 0.5 0.01 SBP (mm Hg) 140(135–145) 127(124–135) 0.01 143(135–151) 131(124–140) 0.002 0.8 DBP (mm Hg) 85(81–87) 85(80–88) 0.3 87(80–93) 84(72–86) 0.02 0.2 TC (mg/dL) 233(194–257) 204(172–220) 0.04 213(183–248) 158(139–185) 0.002 0.2 TG (mg/dL) 140(122–188) 160(136–213) 0.1 145(119–173) 90(68–136) 0.07 0.08 HDL-c (mg/dL) 47(37–56) 39(34–45) 0.01 51(37–56) 42(38–56) 0.5 0.7 Non-HDL (mg/dL) 186(159–192) 165(140–187) 0.09 162(133–182) 120(88–140) 0.002 0.1 LDL (mg/dL) 148(117–177) 127(82–143) 0.03 134(108–144) 100(75–113) 0.004 0.3 OxLDL (u/mL) 135(97–162) 175(140–189) 0.02 125(90–144) 114(98–152) 0.9 0.4 OxLDL/LDL 0.9(0.7–1.2) 1.3(1.1–1.8) 0.04 1.1(0.6–1.3) 1.3(0.9–1.3) 0.3 0.4 Data are presented as median (interquartile range). Comparisons between lifestyle modifications (TLC) and amlodipine/atorvastatin (A/A) or placebo groups were performed by paired t -test for each intervention arm. Non-parametric t -test with Wilcoxon matched-pairs signed rank was used to assess the delta change over 1-year intervention between study arms. p < 0.05 was considered statistically significant. BMI, body mass index; DBP, diastolic blood pressure; FBG, fasting blood glucose; HDL-C, high density lipoprotein-cholesterol; LDL-C, low-density lipoprotein cholesterol; Ox-LDL, oxidized LDL; SBP, systolic blood pressure; TC, total cholesterol; TG, triglyceride. Fig. A.1 Effect of interventions on metabolic syndrome (MetS). All patients had the metabolic syndrome at baseline. TLC + placebo was nearly as effective as TLC + A/A in improving patients with MetS ( p = 0.01 and p = 0.04 for TLC + A/A and TLC + placebo; respectively). Fig. A.1 Fig. A.2 Effect of weight loss on plasma oxidized low density lipoprotein (Ox-LDL) levels. A. Change in Ox-LDL within groups shows that only in the TLC + placebo group, patients who lost weight had significantly decreased Ox-LDL ( p = 0.04 for weight loss vs. no weight loss). Weight loss cutoff level = −1.5 kg (dotted vertical line). B. Change in Ox-LDL significantly correlated with weight change in the TLC + placebo group only ( r = 0.64; p = 0.04). Fig. A.2 Fig. A.3 Linear regression analyses. Adipose tissue health, expressed as AUC FFA 30–120 during oral glucose tolerance test, was significantly and directly correlated with change in body fat mass loss ( r = 0.485, p = 0.036). The AUC FFA 30–120 was log transformed for skewed distribution prior to use in the analysis. Fig. A.3
Funding Information:
The authors would like to express their gratitude to the study participants for their dedication and time; and to Dr. Peter Snell help with underwater weighing; and Dr. Magdalene Szuszkiewicz-Garcia and Dr. Thanalakshmi Seenivasan, PhD for their assistance in patient recruitment. This study was funded by Pfizer Inc., and conducted with the support of the Institute for Translational Sciences at the University of Texas Medical Branch, supported in part by a Clinical and Translational Science Award (UL1 TR001439) and Mentored Career Development (KL2) Award (KL2TR001441) from the National Center for Advancing Translational Sciences, National Institutes of Health. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Publisher Copyright:
© 2019 Elsevier Inc.
PY - 2020/3
Y1 - 2020/3
N2 - Aims: To examine whether addition of amlodipine (5 mg)/atorvastatin (10 mg) A/A to Therapeutic Lifestyle change intervention (TLC) would beneficially modulate Metabolic Syndrome (MetS) and oxidized low-density lipoprotein (Ox-LDL) levels. Methods: Patients with MetS (n = 53) were randomized to TLC + placebo or TLC + A/A for 12 months. Anthropometric measurements, blood pressure (BP), lipid profile, plasma Ox-LDL, and area under the curve of free fatty acid (AUCFFA) during oral glucose tolerance test, a marker of adipose tissue health, were assessed before and after the intervention. Results: Twenty-six patients completed the study with an overall improvement of MetS (p = 0.02). TLC + placebo was beneficial in reversing MetS comparable to TLC + A/A (54% vs. 39%; p = 0.08). Both treatments decreased systolic BP (p ≤ 0.01). TLC + A/A also decreased diastolic BP and triglyceride levels. The changes in Ox-LDL levels directly correlated with changes in weight in the TLC-placebo group (r = 0.64; p = 0.04). AUCFFA determined the loss of fat mass (r = 0.472, p = 0.03). Conclusions: 1) Addition of A/A has the advantage of improving the lipid profile and BP; but TLC alone was comparable to TLC + A/A in improving MetS; 2) weight change determines the TLC-associated change in Ox-LDL levels; and 3) AT metabolic health is a significant predictor of TLC-associated loss of body fat mass.
AB - Aims: To examine whether addition of amlodipine (5 mg)/atorvastatin (10 mg) A/A to Therapeutic Lifestyle change intervention (TLC) would beneficially modulate Metabolic Syndrome (MetS) and oxidized low-density lipoprotein (Ox-LDL) levels. Methods: Patients with MetS (n = 53) were randomized to TLC + placebo or TLC + A/A for 12 months. Anthropometric measurements, blood pressure (BP), lipid profile, plasma Ox-LDL, and area under the curve of free fatty acid (AUCFFA) during oral glucose tolerance test, a marker of adipose tissue health, were assessed before and after the intervention. Results: Twenty-six patients completed the study with an overall improvement of MetS (p = 0.02). TLC + placebo was beneficial in reversing MetS comparable to TLC + A/A (54% vs. 39%; p = 0.08). Both treatments decreased systolic BP (p ≤ 0.01). TLC + A/A also decreased diastolic BP and triglyceride levels. The changes in Ox-LDL levels directly correlated with changes in weight in the TLC-placebo group (r = 0.64; p = 0.04). AUCFFA determined the loss of fat mass (r = 0.472, p = 0.03). Conclusions: 1) Addition of A/A has the advantage of improving the lipid profile and BP; but TLC alone was comparable to TLC + A/A in improving MetS; 2) weight change determines the TLC-associated change in Ox-LDL levels; and 3) AT metabolic health is a significant predictor of TLC-associated loss of body fat mass.
KW - Amlodipine/atorvastatin
KW - Metabolic syndrome
KW - Ox-LDL
KW - Oxidative stress
KW - Therapeutic lifestyle
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U2 - 10.1016/j.jdiacomp.2019.107480
DO - 10.1016/j.jdiacomp.2019.107480
M3 - Article
C2 - 31902653
AN - SCOPUS:85077329900
SN - 1056-8727
VL - 34
JO - Journal of Diabetes and its Complications
JF - Journal of Diabetes and its Complications
IS - 3
M1 - 107480
ER -