PMID- 29221717 OWN - NLM STAT- MEDLINE DCOM- 20180926 LR - 20221207 IS - 1878-0334 (Electronic) IS - 1871-4021 (Linking) VI - 12 IP - 3 DP - 2018 May TI - Effect of metformin combined with lifestyle modification versus lifestyle modification alone on proinflammatory-oxidative status in drug-naive pre-diabetic and diabetic patients: A randomized controlled study. PG - 257-267 LID - S1871-4021(17)30357-0 [pii] LID - 10.1016/j.dsx.2017.11.003 [doi] AB - BACKGROUND: Targeting biomarkers of oxidative-proinflammatory stress may result in improvement of modifiable metabolic syndrome, pre-diabetes and diabetes risk factors and subsequent risk reduction. METHODS: 64 newly diagnosed antihyperglycemic treatment-naive prediabetic and type 2 diabetes mellitus (T2DM) patients were randomly assigned using block design to either metformin combined with therapeutic lifestyle changes (TLC) or TLC alone. Body mass index (BMI), waist circumference, blood pressure, fasting plasma glucose (FPG), glycated hemoglobin (HbA1c), fasting lipid profile, plasma oxidative status and tumor necrosis factor (TNF)-alpha were measured at baseline, after 3 months and after 6 months from baseline. RESULTS: Except for HbA1c, baseline values did not differ significantly between the two groups. The post 3-months relative reductions in BMI (P=0.014) and HbA1c (P=0.037) in metformin combined with TLC intervention were significantly greater than those in TLC alone group. TNFalpha plasma levels were decreased significantly vs. baseline by metformin combined with TLC intervention (-22.90+/-46.76%, P=0.01). Conversely, TLC alone basically worsened proinflammatory status (42.40+/-40.82 %), P<0.001. Metformin with TLC treatment effected a therapeutic decrement of the oxidative stress (-15.44+/-35.32%, P=0.029 vs. baseline) unlike TLC alone (61.49+/-122.66%, P=0.01 vs. baseline). Both interventions' effects were sustained in the 6-month follow up periods. CONCLUSION: In both intervention groups, the relative changes in plasma TNFalpha were significantly correlated (P<0.01) with systolic blood pressure and the relative changes in oxidative stress were markedly correlated (P<0.05) with total cholesterol. CI - Copyright (c) 2017 Diabetes India. Published by Elsevier Ltd. All rights reserved. FAU - Bulatova, Nailya AU - Bulatova N AD - School of Pharmacy, The University of Jordan, Queen Rania Street, Amman 11942, Jordan. FAU - Kasabri, Violet AU - Kasabri V AD - School of Pharmacy, The University of Jordan, Queen Rania Street, Amman 11942, Jordan. Electronic address: v.kasabri@ju.edu.jo. FAU - Qotineh, Amenah AU - Qotineh A AD - School of Pharmacy, The University of Jordan, Queen Rania Street, Amman 11942, Jordan. FAU - Al-Athami, Taiba AU - Al-Athami T AD - School of Pharmacy, The University of Jordan, Queen Rania Street, Amman 11942, Jordan. FAU - Yousef, Al-Motassem AU - Yousef AM AD - School of Pharmacy, The University of Jordan, Queen Rania Street, Amman 11942, Jordan. FAU - AbuRuz, Salah AU - AbuRuz S AD - School of Pharmacy, The University of Jordan, Queen Rania Street, Amman 11942, Jordan; College of Pharmacy, Al Ain University of Science and Technology, AL Ain, Abu Dhabi, United Arab Emirates. FAU - Momani, Munther AU - Momani M AD - School of Medicine, The University of Jordan, Queen Rania Street, Amman 11942, Jordan. FAU - Zayed, Aymen AU - Zayed A AD - School of Medicine, The University of Jordan, Queen Rania Street, Amman 11942, Jordan. LA - eng PT - Journal Article PT - Randomized Controlled Trial DEP - 20171123 PL - Netherlands TA - Diabetes Metab Syndr JT - Diabetes & metabolic syndrome JID - 101462250 RN - 0 (Biomarkers) RN - 0 (Blood Glucose) RN - 0 (Glycated Hemoglobin A) RN - 0 (Hypoglycemic Agents) RN - 0 (Inflammation Mediators) RN - 0 (Lipids) RN - 0 (hemoglobin A1c protein, human) RN - 9100L32L2N (Metformin) SB - IM MH - Adult MH - Aged MH - Biomarkers/analysis MH - Blood Glucose/analysis MH - Diabetes Mellitus, Type 2/*drug therapy/metabolism/pathology MH - Female MH - Follow-Up Studies MH - Glycated Hemoglobin/analysis MH - Humans MH - Hypoglycemic Agents/*therapeutic use MH - Inflammation Mediators/*metabolism MH - *Life Style MH - Lipids/blood MH - Male MH - Metformin/*therapeutic use MH - Middle Aged MH - Oxidative Stress/*drug effects MH - Prediabetic State/*drug therapy/metabolism/pathology MH - Prognosis MH - Young Adult OTO - NOTNLM OT - Diabetes OT - Metformin OT - Prediabetes OT - Proinflammatory-oxidative status OT - Therapeutics lifestyle changes (TLC) EDAT- 2017/12/10 06:00 MHDA- 2018/09/27 06:00 CRDT- 2017/12/10 06:00 PHST- 2017/09/28 00:00 [received] PHST- 2017/11/22 00:00 [accepted] PHST- 2017/12/10 06:00 [pubmed] PHST- 2018/09/27 06:00 [medline] PHST- 2017/12/10 06:00 [entrez] AID - S1871-4021(17)30357-0 [pii] AID - 10.1016/j.dsx.2017.11.003 [doi] PST - ppublish SO - Diabetes Metab Syndr. 2018 May;12(3):257-267. doi: 10.1016/j.dsx.2017.11.003. Epub 2017 Nov 23.