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

NCT05612269 | Unknown DMC

• 1 other identifier: ministry of health
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Diabetes Mellitus, Type 2; Interleukin 6; SGLT2 Inhibitors

Outcome Measures

Primary Outcomes (1)

• Reducing the risk of cancer among Diabetics with SGLT2 inhibitors

  9 month after treatment

Secondary Outcomes (1)

• measurement of inflammatory factors like interleukin-6

  9 month after treatment

Interventions

interleukin 6 DIAGNOSTIC_TEST

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

Also known as: CRP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

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

You may not qualify if:

• diabetic ketoacidosis severe diseases pregnant type 1 diabetes

Sponsors & Collaborators

• Ministry of Health, Saudi Arabia: lead

Study Sites (1)

ministry of health , First health cluster , Riaydh

Riyadh, N/A (Non-US), 11411, Saudi Arabia

Location

MeSH Terms

Conditions

Neoplasms; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical scientist

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 10, 2022
• Study Start: September 1, 2022
• Primary Completion: October 31, 2022
• Study Completion: January 31, 2024
• Last Updated: November 10, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)