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

Sponsor
Ministry of Health, Saudi Arabia (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05612269
Collaborator
(none)
200
1
17
11.8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: interleukin 6

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

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
SGLT2 Inhibitors and Reducing the Risk of Cancers Among Diabetics , an Observational Study
Actual Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Oct 31, 2022
Anticipated Study Completion Date :
Jan 31, 2024

Outcome Measures

Primary Outcome Measures

  1. Reducing the risk of cancer among Diabetics with SGLT2 inhibitors [9 month after treatment]

Secondary Outcome Measures

  1. measurement of inflammatory factors like interleukin-6 [9 month after treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 ministry of health , First health cluster , Riaydh Riyadh N/A (Non-US) Saudi Arabia 11411

Sponsors and Collaborators

  • Ministry of Health, Saudi Arabia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Amr kamel khalil Ahmed, clinical scientist, Ministry of Health, Saudi Arabia
ClinicalTrials.gov Identifier:
NCT05612269
Other Study ID Numbers:
  • ministry of health
First Posted:
Nov 10, 2022
Last Update Posted:
Nov 10, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 10, 2022