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

NCT05087225 | Unknown

• 1 other identifier: ministry of health saudia
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Diabetic Complication; Covid19 Virus Infection; Hypoglycemia; Polyethylene Glycol Adverse Reaction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• enhancements of hypoglycemic effects of metformin and insulin by PEG

  6 month

Interventions

polyethelyene glycol BIOLOGICAL

the excipients at covid-19 vaccines

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• \- 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ministry of Health, Saudi Arabia: lead

Study Sites (1)

ministry of health , First health cluster , Riaydh

Riyadh, N/A (Non-US), 11411, Saudi Arabia

Location

MeSH Terms

Conditions

Diabetes Complications; COVID-19; Hypoglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Endocrine System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ministry of health , saudia arabia

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: October 21, 2021
• Study Start: November 11, 2021
• Primary Completion: March 11, 2022
• Study Completion: April 1, 2022
• Last Updated: November 8, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)