SGLT2 Inhibitors and Reducing the Risk of Cancers Among Diabetics , an Observational Study

Cancer Clinical Trial

Official title:

SGLT2 Inhibitors and Reducing the Risk of Cancers Among Diabetics , an Observational Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05612269
• Other study ID #: ministry of health
• Status: Enrolling by invitation
• Start date: September 1, 2022
• Est. completion date: January 31, 2024

Study information

• Verified date: October 2022
• Source: Ministry of Health, Saudi Arabia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: January 31, 2024
• Est. primary completion date: October 31, 2022
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 18 -70 years male or female diabetics patients smoker or not smokers SGLT-2 inhibitors no history of cancer no severe complications

Exclusion Criteria:

• diabetic ketoacidosis severe diseases pregnant type 1 diabetes

Related Conditions & MeSH terms

• Cancer
• Diabetes Mellitus, Type 2

Intervention

Diagnostic Test:
• interleukin 6
follow up of type 2 diabetes with SGLT2 inhibitors like empagliflozin, canagliflozin, and dapagliflozin for measurement of inflammatory factors like interleukin-6, CRP

Locations

Country	Name	City	State
Saudi Arabia	ministry of health , First health cluster , Riaydh	Riyadh	N/A (Non-US)

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Health, Saudi Arabia

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reducing the risk of cancer among Diabetics with SGLT2 inhibitors		9 month after treatment
Secondary	measurement of inflammatory factors like interleukin-6		9 month after treatment