CancerNCT05612269
SGLT2 Inhibitors and Reducing the Risk of Cancers Among Diabetics , an Observational Study
An observational study of Cancer and Diabetes Mellitus, Type 2, run by Ministry of Health, Saudi Arabia at 1 site in Saudi Arabia.
Trial summary
Since the discovery of SGLT2 inhibitors, there is a great shift in diabetic treatment, so this drug is magic, this drug can reduce the blood sugar level by blocking the reabsorption of glucose in the kidney and increasing glucose excretion the first discovery by Josef von Mering who discovered the glucosuric effect of… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cancer, Diabetes Mellitus, Type 2, Interleukin 6
- What is being tested?
- interleukin 6
- How many people
- 200 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Sep 2022to 31 Jan 2024
- 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 18 to 70 years
- All sexes
- Adult, Older adult
Study population: A study of a group of individuals having diabetes type 2 above 18 years taking any types of SGLT2 inhibitors like canagliflozin, dapagliflozin, and empagliflozin. similar at the disease stage and no history of any type of cancer we will measure the interleukin 6 and CRP among these patients and follow up for one year for calculating the risk of occurrence of any type of cancer
Who may be able to join
- 18 -70 years male or female diabetics patients smoker or not smokers SGLT-2 inhibitors no history of cancer no severe complications
Who cannot join
- diabetic ketoacidosis severe diseases pregnant type 1 diabetes
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
Since the discovery of SGLT2 inhibitors, there is a great shift in diabetic treatment, so this drug is magic, this drug can reduce the blood sugar level by blocking the reabsorption of glucose in the kidney and increasing glucose excretion the first discovery by Josef von Mering who discovered the glucosuric effect of phlorizin. Phlorizin is the progenitor of contemporary SGLT2 inhibitors, the FDA did not consider the work of Baron Josef von Mering, since he had already discovered acidosis following the administration of phlorizin in 1888.
Now SGLT2 inhibitors are used widely and even for heart failure without diabetes as this drug is useful and with lower risk of death from observational studies The 2008 FDA guidance had a major impact on the cardiovascular (CV) risk assessment of recently approved antidiabetic drugs, many trials were done on SGLT2 inhibitors like the EMPA-REG OUTCOME trial, the CANVAS trial program, MACE these groups have CVS benefits and also renal benefits as regards, we suspect long-term benefits and immunity aspect these groups play an important role in cancer incidence from meta-analysis and systematic review, suggests that SGLT2 inhibition results in a reduction of inflammatory markers like interleukin-6 in animal models, further validating the suggested anti-inflammatory mechanism of action.
Read the detailed description
The map of treatment of diabetes and obesity was changed dramatically and newer drugs were discovered in the last 10 years for improving the quality of patients and prevent complications and cardiovascular and renal benefits from SGLT2 inhibitors In our study, we will discuss the risk of cancer among diabetics on SGLT2 inhibitors and measurement of inflammatory factors like CRP and interleukin -6 alongside the other investigations the study included 200 adults patients with type 2 diabetes on SGLT2 inhibitors and follow up these patients for one year for the inflammatory factors and risk of cancer among them and this study include patients from 18 years to 70 years having diabetes type 2 male or female, smoker or not smokers, non-diabetic ketoacidosis
- Conditions
- Cancer, Diabetes Mellitus, Type 2, Interleukin 6, SGLT2 Inhibitors
- Being tested
- interleukin 6
- Medical subject headings
- Neoplasms, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interleukin 6Diagnostic test
Also called CRP
follow up of type 2 diabetes with SGLT2 inhibitors like empagliflozin, canagliflozin, and dapagliflozin for measurement of inflammatory factors like interleukin-6, CRP
What is being measured
The primary outcome is the main question the study is designed to answer.
Reducing the risk of cancer among Diabetics with SGLT2 inhibitors
Measured: 9 month after treatment
Secondary outcomes (1)
measurement of inflammatory factors like interleukin-6
Measured: 9 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start1 Sep 2022
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 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
- NCT05612269
- Sponsor's protocol ID
- ministry of health
- Status last verified
- Oct 2022
- First submitted
- 28 Oct 2022
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SGLT2 Inhibitors and Reducing the Risk of Cancers Among Diabetics , an Observational Study
- ClinicalTrials.gov ID
- NCT05612269
- Acronym / sponsor ID
- ministry of health
- Conditions
- Cancer, Diabetes Mellitus, Type 2, Interleukin 6, SGLT2 Inhibitors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ministry of Health, Saudi ArabiaOther government
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 10 Nov 2022 (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.
Since the discovery of SGLT2 inhibitors, there is a great shift in diabetic treatment, so this drug is magic, this drug can reduce the blood sugar level by blocking the reabsorption of glucose in the kidney and increasing glucose excretion the first discovery by Josef von Mering who discovered the glucosuric effect of phlorizin. Phlorizin is the progenitor of contemporary SGLT2 inhibitors, the FDA did not consider the work of Baron Josef von Mering, since he had already discovered acidosis following the administration of phlorizin in 1888.
Now SGLT2 inhibitors are used widely and even for heart failure without diabetes as this drug is useful and with lower risk of death from observational studies The 2008 FDA guidance had a major impact on the cardiovascular (CV) risk assessment of recently approved antidiabetic drugs, many trials were done on SGLT2 inhibitors like the EMPA-REG OUTCOME trial, the CANVAS trial program, MACE these groups have CVS benefits and also renal benefits as regards, we suspect long-term benefits and immunity aspect these groups play an important role in cancer incidence from meta-analysis and systematic review, suggests that SGLT2 inhibition results in a reduction of inflammatory markers like interleukin-6 in animal models, further validating the suggested anti-inflammatory mechanism of action.
Detailed description
The map of treatment of diabetes and obesity was changed dramatically and newer drugs were discovered in the last 10 years for improving the quality of patients and prevent complications and cardiovascular and renal benefits from SGLT2 inhibitors In our study, we will discuss the risk of cancer among diabetics on SGLT2 inhibitors and measurement of inflammatory factors like CRP and interleukin -6 alongside the other investigations the study included 200 adults patients with type 2 diabetes on SGLT2 inhibitors and follow up these patients for one year for the inflammatory factors and risk of cancer among them and this study include patients from 18 years to 70 years having diabetes type 2 male or female, smoker or not smokers, non-diabetic ketoacidosis
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A study of a group of individuals having diabetes type 2 above 18 years taking any types of SGLT2 inhibitors like canagliflozin, dapagliflozin, and empagliflozin. similar at the disease stage and no history of any type of cancer we will measure the interleukin 6 and CRP among these patients and follow up for one year for calculating the risk of occurrence of any type of cancer
Key inclusion criteria (1 listed)
- 18 -70 years male or female diabetics patients smoker or not smokers SGLT-2 inhibitors no history of cancer no severe complications
Key exclusion criteria (1 listed)
- diabetic ketoacidosis severe diseases pregnant type 1 diabetes
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 |
|---|---|---|
| interleukin 6Also: CRPfollow up of type 2 diabetes with SGLT2 inhibitors like empagliflozin, canagliflozin, and dapagliflozin for measurement of inflammatory factors like interleukin-6, CRP | Diagnostic test | – |
Primary outcome
Reducing the risk of cancer among Diabetics with SGLT2 inhibitors
Time frame: 9 month after treatment
1 secondary outcome
measurement of inflammatory factors like interleukin-6
Time frame: 9 month after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- 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 Cancer and Diabetes Mellitus, Type 2, 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 10 Nov 2022. 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?
Reducing the risk of cancer among Diabetics with SGLT2 inhibitors (time frame: 9 month after treatment). 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 10 Nov 2022; AzTrials last refreshed its copy on 8 Nov 2026.