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Cardiovascular Diabetology
Published in: Cardiovascular Diabetology 1/2017

Open Access 01-12-2017 | Original investigation

Combined effect of metformin with ascorbic acid versus acetyl salicylic acid on diabetes-related cardiovascular complication; a 12-month single blind multicenter randomized control trial

Authors: Syed Wasif Gillani, Syed Azhar Syed Sulaiman, Mohi Iqbal Mohammad Abdul, Mirza R. Baig

Published in: Cardiovascular Diabetology | Issue 1/2017

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Abstract

Background

We aimed to investigate the efficacy of ascorbic acid and acetylsalicylic acid among type II diabetes mellitus patients using metformin (only) for diabetes management therapy.

Method

A 12-month single blinded multicenter randomized control trial was designed to investigate the measured variables [Glycated Hemoglobin (HbA1c), Renal function, Albumin Creatinine Ratio (ACR) etc.]. The trial was randomized into 2 experimental parallel arms (ascorbic acid vs acetylsalicylic acid) were blinded with study supplements in combination with metformin and findings were compared to control arm with metformin alone and blinded with placebo. Withdrawal criteria was defined to maintain the equity and balance in the participants in the whole trial.

Finding

Patients with metformin and ascorbic acid (parallel arm I) was twice more likely to reduce HbA1c than metformin alone (control arm) in a year (OR 2.31 (95% CI 1.87–4.42) p < 0.001). Also Parallel arm I was ten times more likely to reduced risk factors contributing to long-term diabetes complications than participants of arm II in a year (OR 10.38 (95% CI 6.91–15.77) p < 0.001). In contrast, parallel arm II patients were seven times more effective to reduce the risk of expected CVD development in 10 years than arm I (OR 7.54 (95% CI 3.76–10.32) p < 0.001).

Conclusions

The trial concluded that ascorbic acid with metformin is more effective against reducing risks for diabetes related long-term complications (including ACR).
TRIAL details Registration No: NTR-6100, Registry Name: Netherlands Trial Registry, URL: http://​www.​trialregister.​nl/​trialreg/​admin/​rctview.​asp?​TC=​6100, Date of Registration: 20th October, 2016, Date of first Enrollment: 1 November, 2015.
Appendix
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Metadata
Title
Combined effect of metformin with ascorbic acid versus acetyl salicylic acid on diabetes-related cardiovascular complication; a 12-month single blind multicenter randomized control trial
Authors
Syed Wasif Gillani
Syed Azhar Syed Sulaiman
Mohi Iqbal Mohammad Abdul
Mirza R. Baig
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Cardiovascular Diabetology / Issue 1/2017
Electronic ISSN: 1475-2840
DOI
https://doi.org/10.1186/s12933-017-0584-9

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