Suspicion of Hypoglycemic Effect of mRNA Based Covid-19 Vaccines

Status Enrolling by invitation

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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05087225
Study type	Observational
Source	Ministry of Health, Saudi Arabia
Contact
Status	Enrolling by invitation
Phase
Start date	November 11, 2021
Completion date	April 1, 2022

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03482154` - Malglycemia in the Pediatric Hematopoietic Stem Cell Transplant Population
Completed	`NCT03667053` - Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in T1DM Children	Phase 3
Active, not recruiting	`NCT03422471` - Hypoglycemia and Autonomic Nervous System Function- B2	N/A
Recruiting	`NCT05379686` - Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes	N/A
Completed	`NCT05597605` - The SHINE Study: Safety of Implant and Preliminary Performance of the SHINE SYSTEM in Diabetic Subjects	N/A
Not yet recruiting	`NCT05990933` - Role of Adrenaline in in the Inflammatory Response in Diabetes	N/A
Withdrawn	`NCT03736083` - Introducing CGM at Type 1 Diabetes Diagnosis	N/A
Not yet recruiting	`NCT02909881` - Dose Response Oxidation of a Sweet-corn Derived Sugar (PhytoSpherix) During Exercise in Endurance Trained Athletes	N/A
Completed	`NCT02966275` - Post Bariatric Closed Loop Glucagon Trial	N/A
Withdrawn	`NCT02518022` - How to be Safe With Alcoholic Drinks in Diabetes	N/A
Completed	`NCT02213003` - Allogeneic Islet Cells Transplanted Onto the Omentum	Phase 1/Phase 2
Completed	`NCT01176656` - Hypoglycemia: Physician and Patient Perspectives	N/A
Completed	`NCT01147276` - Vildagliptin and the Glucagon Response to Hypoglycemia in Type 1 Diabetes	Phase 4
Completed	`NCT00998374` - Comparison Between Pyloric Preserving and Non-Pyloric Preserving Bariatric Surgery With Glucose Challenge	N/A
Terminated	`NCT01225159` - Tight Glycaemic Control During Cardiac Surgery	N/A
Completed	`NCT00373854` - Study of How Low Blood Sugar Affects the Way Blood Vessels Work	N/A
Completed	`NCT00285233` - Delayed Mycophenolate Mofetil in Single-Donor Islet Allotransplantation in Type 1 Diabetes	Phase 1/Phase 2
Recruiting	`NCT05916131` - Pilot Feasibility Study for HypoPals, a Mobile Health Program for Improving Hypoglycemia Management.	N/A
Terminated	`NCT04026750` - Insulin Tolerance Test Study in Patients With Type 1 Diabetes	Phase 1
Completed	`NCT05133765` - The SMART B Exercise Study :''The SMART Study''	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms