Diabetic ComplicationNCT05087225
Suspicion of Hypoglycemic Effect of mRNA Based Covid-19 Vaccines (Polyethylene Glycol) Will Happen , Observational Study on Diabetic Patients at Saudia Arabia
An observational study of Diabetic Complication and Covid19 Virus Infection, run by Ministry of Health, Saudi Arabia at 1 site in Saudi Arabia.
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… Read more about this study
- Who is it for?
- Ages 12 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Complication, Covid19 Virus Infection, Hypoglycemia
- What is being tested?
- polyethelyene glycol
- Type of treatment
- Vaccines
- How many people
- 50 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 11 Nov 2021to 1 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- under 12 years above 80 years undergone bariatric surgery no exercises during testing
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
ministry of health , First health cluster , Riaydh
Riyadh, N/A (Non-US), 11411
About this study
Official title: 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
Read the 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.
- Conditions
- Diabetic Complication, Covid19 Virus Infection, Hypoglycemia, Polyethylene Glycol Adverse Reaction
- Being tested
- polyethelyene glycol
- Medical subject headings
- Diabetes Complications, COVID-19, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polyethelyene glycolBiological
the excipients at covid-19 vaccines
What is being measured
The primary outcome is the main question the study is designed to answer.
hypoglycemic effects of polyethylene glycol as excipients covid-19 vaccines at diabetic patients
Measured: 6 month
measurement of blood glucose one month after first or second shot of mRNA based covid-19 vaccines
Measured: 6 month
Secondary outcomes (1)
enhancements of hypoglycemic effects of metformin and insulin by PEG
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start11 Nov 2021 (estimated)
- Primary completion11 Mar 2022 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Saudi Arabia
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Amr kamel khalil Ahmed, Ministry of Health, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087225
- Sponsor's protocol ID
- ministry of health saudia
- Status last verified
- Oct 2021
- First submitted
- 20 Oct 2021
- Last updated
- 8 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suspicion of Hypoglycemic Effect of mRNA Based Vaccines (Polyethylene Glycol) Will Happen , Observational Study at Saudia Arabia
- ClinicalTrials.gov ID
- NCT05087225
- Acronym / sponsor ID
- ministry of health saudia
- Conditions
- Diabetic Complication, Covid19 Virus Infection, Hypoglycemia, Polyethylene Glycol Adverse Reaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ministry of Health, Saudi ArabiaOther government
- Study start
- 11 Nov 2021 (estimated)
- Primary completion
- 11 Mar 2022 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 21 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- under 12 years above 80 years undergone bariatric surgery no exercises during testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| polyethelyene glycolthe excipients at covid-19 vaccines | Biological | – |
Primary outcome
hypoglycemic effects of polyethylene glycol as excipients covid-19 vaccines at diabetic patients
Time frame: 6 month
measurement of blood glucose one month after first or second shot of mRNA based covid-19 vaccines
Time frame: 6 month
1 secondary outcome
enhancements of hypoglycemic effects of metformin and insulin by PEG
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Complication and Covid19 Virus Infection, run by Ministry of Health, Saudi Arabia at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hypoglycemic effects of polyethylene glycol as excipients covid-19 vaccines at diabetic patients (time frame: 6 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021; AzTrials last refreshed its copy on 8 Nov 2026.