Suspicion of Hypoglycemic Effect of mRNA Based Covid-19 Vaccines (Polyethylene Glycol) Will Happen , Observational Study on Diabetic Patients at Saudia Arabia

Suspicion of Hypoglycemic Effect of mRNA Based Vaccines (Polyethylene Glycol) Will Happen , Observational Study at Saudia Arabia

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Hypoglycemia; Diabetic Complication; Covid19 Virus Infection; Polyethylene Glycol Adverse Reaction
• Intervention / Treatment: Biological: polyethelyene glycol

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• Saudi Arabia
  • N/A (Non-US)
    • Riyadh, N/A (Non-US), Saudi Arabia, 11411
      • ministry of health , First health cluster , Riaydh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population is a group of individuals selected on the basis of inclusion and exclusion criteria which relate to the variables being studied. It is the population from which the sample population will be randomly or purposively selected

Description

Inclusion Criteria:

- Male and female subjects between the ages of 12 and 80 years, inclusive, with Type 1 or 2 diabetes mellitus as defined by the American Diabetes Association (Diabetes care, Vol. 21: S5- S19, 1998) for more than one year.

Exclusion Criteria:

• under 12 years above 80 years undergone bariatric surgery no exercises during testing

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
hypoglycemic effects of polyethylene glycol as excipients covid-19 vaccines at diabetic patients	6 month
measurement of blood glucose one month after first or second shot of mRNA based covid-19 vaccines	6 month

Secondary Outcome Measures

Outcome Measure	Time Frame
enhancements of hypoglycemic effects of metformin and insulin by PEG	6 month

Collaborators and Investigators

• Sponsor: Ministry of Health, Saudi Arabia

Study record dates

Study Major Dates

• Study Start (Anticipated): November 11, 2021
• Primary Completion (Anticipated): March 11, 2022
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: October 20, 2021
• First Submitted That Met QC Criteria: October 20, 2021
• First Posted (Actual): October 21, 2021

Study Record Updates

• Last Update Posted (Actual): November 8, 2021
• Last Update Submitted That Met QC Criteria: October 30, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Endocrine System Diseases; Diabetes Mellitus; COVID-19; Hypoglycemia; Diabetes Complications
• Other Study ID Numbers: ministry of health saudia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No