Using of SGLt2 Inhibitors in Patients With Type 2 DM

February 17, 2024 updated by: Caroline Refaat labib, Assiut University

Efficacy and Safety of Incorporating Sodium-glucose Cotransporter-2 Inhibitors to Regimens of Diabetes Patients Already Receiving Therapy

To detect the efficacy of SGLT2i in improving the metabolic parameters in patients with type 2 diabetes.

- To detect the side-effects of SGLT2i

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Type 2 diabetes mellitus (T2DM) is a worldwide health problem, with a continuously increasing prevalence . Good management of blood glucose level is critical to delay progression of the underlying metabolic dysfunction and to reduce the risk of diabetic complications . Sodium-glucose cotransporter-2 inhibitors (SGLT2i) are a new class of antidiabetic drug acting by increasing urinary glucose excretion. First approved in 2014, SGLT2i have been widely used to treat patients with type 2 diabetes They are effective in reducing blood glucose, and surprisingly have shown benefits beyond glycaemic control .

Physicians have reported improved hypertension, heart failure, chronic kidney disease, fatty liver disease and obesity However, SGLT inhibitors are not magical drugs, and their use is not free of side effects ( Reported side effects include urinary tract infections, genital infection, dehydration, and hypotension, plus the usual side effects of antidiabetic medications as hypoglycemia . The optimum practical guideline for adding SGLT2 inhibitors to treatment regimens of patients with diabetes is controversial .Many local guidelines and treatment policies exist, yet we need to develop our own local policy at Assiut University hospitals to suit our patients needs and expectations, balancing between efficacy and side effects.

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Adult diabetic type 2patients

Description

Inclusion Criteria:

  1. Adults (≥18 years)
  2. both genders ( male and female)
  3. type 2 diabetic patients

Exclusion Criteria:

  1. history of svere hypoglycemia
  2. patients with history of weight loss
  3. Patients with history of recurrent UTI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of adding SGLTi on BP
Time Frame: Six months
Compare the effect on blood pressure measurement ( SBP and DBP in mmHg) in SGLTi receivers and non SGLTi receivers
Six months
Effect of adding SGLTi on BMI
Time Frame: Six months
compare the effect on BMI ( weight in kg and height in m2) in SGLTi receivers and non SGLTi receivers.
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 30, 2025

Study Registration Dates

First Submitted

January 17, 2024

First Submitted That Met QC Criteria

February 17, 2024

First Posted (Estimated)

February 21, 2024

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 17, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGLt2i in diabetic type 2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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