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

Abstract

BackgroundWe aimed to investigate the efficacy of ascorbic acid and acetylsalicylic acid among type II diabetes mellitus patients using metformin (only) for diabetes management therapy.MethodA 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.FindingPatients 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).ConclusionsThe 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.Electronic supplementary materialThe online version of this article (doi:10.1186/s12933-017-0584-9) contains supplementary material, which is available to authorized users.

Ascorbic acid supplementation improves postprandial glycaemic control and blood pressure in individuals with type 2 diabetes: Findings of a randomized cross‐over trial

“…Interestingly, we did not find a significant improvement in HbA1c despite improvement in post‐prandial glucose responses. Previous studies that reported significant improvements in HbA1c after AA supplementation included more participants, enrolled participants with a higher baseline HbA1c and/or undertook AA supplementation for a longer period than we did. Nonetheless, other findings we report suggest that HbA1c may be improved with a more prolonged supplementation period.…”

“…8 Improvements in insulin sensitivity with AA supplementation may subsequently promote improvements in glycaemic control. Indeed, findings of some studies, 7,[9][10][11][12] but not others, 13 support the efficacy of AA supplementation in improving glycaemic outcomes, including lowering of HbA1c and fasting glucose concentrations in individuals with T2D.…”

Inadequate Vitamin C Status in Prediabetes and Type 2 Diabetes Mellitus: Associations with Glycaemic Control, Obesity, and Smoking

“…Indeed, a recent meta-analysis of 15 randomized control trials (RCTs) investigating vitamin C supplementation and insulin resistance and biomarkers of glycaemic control (fasting glucose, HbA1c) found that doses of ≥200 mg/day vitamin C significantly reduced glucose concentrations in patients with T2DM, particularly if the intervention was for more than 30 days and in older individuals [ 36 ]. Furthermore, a recent 12 month RCT found that treating those with T2DM with both Metformin and vitamin C was more effective at reducing HbA1c and risk factors for diabetes-related long-term complications than treating with Metformin alone [ 37 ].…”

Predictors of Health-Related Quality of Life Among Patients with Type II Diabetes Mellitus Who Are Insulin Users: A Multidimensional Model

“… 7 , 10 Monitoring and control of blood glucose is a viable tool to determine disease control and rational therapy. 3 , 6 However, several studies reported a strong influence of patient-related factors on blood glucose intolerance, including perception and self-care behavior. 3 , 6 , 8 , 11 Self-care, including self-monitoring of blood glucose, showed a positive effect on controlled glycemic levels, 4 , 7 , 9 , 10 , 11 considering the fact that diabetes-related disease knowledge plays a vital role in association with self-care behaviors of a patient.…”

“… 15 None of the studies have discussed these factors among Malaysian populations. Malaysia is a multiethnic society with different lifestyle patterns and religious practices, 2 , 3 , 8 , 9 mainly consisting of Malay, Chinese, and Indian ethnicity. In this diverse population, it is essential to determine the HRQoL multiconstruct model.…”