Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
NCT number |
NCT05087225 |
Other study ID # |
ministry of health saudia |
Secondary ID |
|
Status |
Enrolling by invitation |
Phase |
|
First received |
|
Last updated |
|
Start date |
November 11, 2021 |
Est. completion date |
April 1, 2022 |
Study information
Verified date |
October 2021 |
Source |
Ministry of Health, Saudi Arabia |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
vaccines for covid-19 are gold strategy and great achievement at this century for protection
against complications of covid-19 , development of many vaccines with different technology
represent a big challenge for this disease so the world live bad days and the vaccines save
world to see the light once again , mRNA based vaccines have a new technology which designed
before for cancer therapy, this technology is very effective , producible and fast for future
disease targets but these vaccine must contain excipients for preservation of this technology
mRNA so we now study these side effects of excipients and we suspect that polyethylene glycol
as excipients have big role at hypoglycemic effects with antidiabetic medications like
metformin and insulin especially at children and older age
Description:
diabetics patients as chronic diseases represent high percentage at all the world and high
priority for vaccines against covid-19 so we will focus on these group as need more attention
and need best health and quality of life so my study concentrate on diabetics patients from
12 years to 80 years who were taken mRNA based vaccines and suffer from recurrent
hypoglycemia , i will check the blood glucose one month after the first or second injection
of mRNA based vaccines Pfizer or moderna vaccines and study all medicines taken by patients
and suspect what's happen is there is hypoglycemic effect or nor by following up the readings
of blood glucose by glucometers or CGM
there are previous studies about relation of metformin and polyethylene glycol injection and
this study conclude that The subcutaneous injection of PEX168 once a week can effectively,
continuously and safely improve HbA1c levels in patients with T2D when combined with
metformin ( Gao F, Lv X, Mo Z, Ma J, Zhang Q, Yang G, Liu W, Li Q, Zhou J, Bao Y, Jia W.
Efficacy and safety of polyethylene glycol loxenatide as add-on to metformin in patients with
type 2 diabetes: A multicentre, randomized, double-blind, placebo-controlled, phase 3b trial.
Diabetes Obes Metab. 2020 Dec;22(12):2375-2383. doi: 10.1111/dom.14163. Epub 2020 Sep 6.
PMID: 32744358.