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Trial Title:
SGLT2 Inhibitors and Reducing the Risk of Cancers Among Diabetics , an Observational Study
NCT ID:
NCT05612269
Condition:
Cancer
Diabetes Mellitus, Type 2
Interleukin 6
SGLT2 Inhibitors
Conditions: Official terms:
Diabetes Mellitus, Type 2
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
interleukin 6
Description:
follow up of type 2 diabetes with SGLT2 inhibitors like empagliflozin, canagliflozin, and
dapagliflozin for measurement of inflammatory factors like interleukin-6, CRP
Other name:
CRP
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.
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
Criteria for eligibility:
Study pop:
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
Sampling method:
Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Locations:
Facility:
Name:
ministry of health , First health cluster , Riaydh
Address:
City:
Riyadh
Zip:
11411
Country:
Saudi Arabia
Start date:
September 1, 2022
Completion date:
January 31, 2024
Lead sponsor:
Agency:
Ministry of Health, Saudi Arabia
Agency class:
Other
Source:
Ministry of Health, Saudi Arabia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05612269
