PMID- 33244247
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220418
IS  - 1178-7007 (Print)
IS  - 1178-7007 (Electronic)
IS  - 1178-7007 (Linking)
VI  - 13
DP  - 2020
TI  - Evaluation of the Effect of an Aqueous Extract of Azadirachta indica (Neem) 
      Leaves and Twigs on Glycemic Control, Endothelial Dysfunction and Systemic 
      Inflammation in Subjects with Type 2 Diabetes Mellitus - A Randomized, 
      Double-Blind, Placebo-Controlled Clinical Study.
PG  - 4401-4412
LID - 10.2147/DMSO.S274378 [doi]
AB  - PURPOSE: Neem tree (Azadirachta indica) offers different bioactives ranging from 
      pesticides to therapeutic molecules, depending on which part of the plant is used 
      and the extraction methodology and the solvent used. This study was aimed at 
      evaluating the safety and efficacy of a standardized aqueous extract of 
      Azadirachta indica leaves and twigs (NEEM) on glycemic control, endothelial 
      dysfunction, and systemic inflammation in patients with type 2 diabetes mellitus 
      (T2DM). METHODS: In this randomized, double-blind, placebo-controlled clinical 
      study (RCT), 80 T2DM subjects, who have already been on standard metformin 
      therapy, received either 125 mg, 250 mg, 500 mg of NEEM or placebo twice daily 
      for 12 weeks. Postprandial blood sugar level (PPBS), fasting blood sugar level 
      (FBS), glycosylated hemoglobin (HbA1c), insulin resistance (IR), endothelial 
      function, oxidative stress, systemic inflammation, IL-6 and TNF-alpha, platelet 
      aggregation and lipid profile were assessed. Adverse drug reactions, if any, were 
      noted. GraphPad Prism 8 was used to perform statistical analysis. RESULTS: NEEM 
      at the doses of 125, 250, and 500 mg BID significantly reduced PPBS (from 
      194.4+/-14 to 173.1+/-12.8mg/dL, 192.3+/-17.1 to 161.8+/-9.7mg/dL, and 205.9+/-7.2 to 
      159.3+/-7.1mg/dL, respectively), FBS (from 119.2+/-5.0 to 109.2+/-5.7mg/dL, 115.5+/-4.4 
      to 103.7+/-4.2mg/dL, and 120.7+/-4.2 to 97.3+/-3.7mg/dL, respectively), HbA1c (from 
      6.87 +/- 0.4% to 6.64 +/- 0.4%, 7.52 +/- 0.4% to 6.86 +/- 0.3%, and 7.78 +/- 0.2% to 6.26 +/- 
      0.4%, respectively), and IR (from 4.5 +/- 1.2 to 3.4 +/- 0.9, 3.8 +/- 1.1 to 2.5 +/- 0.6, 
      and 4.6 +/- 1.3 to 2.0 +/- 0.6, respectively) compared to placebo. Also, NEEM 
      significantly improved endothelial function, decreased oxidative stress and 
      systemic inflammation compared to placebo. The efficacy was significant with all 
      the doses, but no effect on platelet aggregation or lipid profile was observed. 
      CONCLUSION: NEEM may significantly ameliorate hyperglycemia, endothelial 
      dysfunction, and systemic inflammation, on top of what metformin could do, in 
      subjects with T2DM.
CI  - (c) 2020 Pingali et al.
FAU - Pingali, Usharani
AU  - Pingali U
AUID- ORCID: 0000-0002-9300-8022
AD  - Department of Pharmacology and Therapeutics, Nizam's Institute of Medical 
      Sciences, Hyderabad, Telangana 500073, India.
FAU - Ali, Mohammed Abid
AU  - Ali MA
AD  - Department of Pharmacology and Therapeutics, Nizam's Institute of Medical 
      Sciences, Hyderabad, Telangana 500073, India.
FAU - Gundagani, Srinivas
AU  - Gundagani S
AD  - Department of Pharmacology and Therapeutics, Nizam's Institute of Medical 
      Sciences, Hyderabad, Telangana 500073, India.
FAU - Nutalapati, Chandrasekhar
AU  - Nutalapati C
AUID- ORCID: 0000-0002-0529-2706
AD  - Department of Pharmacology and Therapeutics, Nizam's Institute of Medical 
      Sciences, Hyderabad, Telangana 500073, India.
LA  - eng
PT  - Journal Article
DEP - 20201117
PL  - New Zealand
TA  - Diabetes Metab Syndr Obes
JT  - Diabetes, metabolic syndrome and obesity : targets and therapy
JID - 101515585
PMC - PMC7683773
OTO - NOTNLM
OT  - Azadirachta indica
OT  - endothelial dysfunction
OT  - hyperglycemia
OT  - insulin resistance
OT  - metformin
OT  - neem
OT  - type 2 diabetes
COIS- The authors declare no competing interests.
EDAT- 2020/11/28 06:00
MHDA- 2020/11/28 06:01
PMCR- 2020/11/17
CRDT- 2020/11/27 05:44
PHST- 2020/07/28 00:00 [received]
PHST- 2020/09/26 00:00 [accepted]
PHST- 2020/11/27 05:44 [entrez]
PHST- 2020/11/28 06:00 [pubmed]
PHST- 2020/11/28 06:01 [medline]
PHST- 2020/11/17 00:00 [pmc-release]
AID - 274378 [pii]
AID - 10.2147/DMSO.S274378 [doi]
PST - epublish
SO  - Diabetes Metab Syndr Obes. 2020 Nov 17;13:4401-4412. doi: 10.2147/DMSO.S274378. 
      eCollection 2020.