Using of SGLt2 Inhibitors in Patients With Type 2 DM

NCT ID: NCT06268977

Last Updated: 2024-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-01

Study Completion Date

2025-03-30

Brief Summary

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

\- To detect the side-effects of SGLT2i

Detailed Description

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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.

Conditions

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Type 2 Diabetes

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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SGLT2 inhibitor

a class of prescription medicines that are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes.

Intervention Type DRUG

Other Intervention Names

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gliflozins or flozins

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Caroline Refaat labib

Resident doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Caroline Refaat labib, Resident

Role: CONTACT

01285655406

Mohammad Hasan AbdEllah-Alawi, Staff

Role: CONTACT

+201115353591

References

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Sun H, Saeedi P, Karuranga S, Pinkepank M, Ogurtsova K, Duncan BB, Stein C, Basit A, Chan JCN, Mbanya JC, Pavkov ME, Ramachandaran A, Wild SH, James S, Herman WH, Zhang P, Bommer C, Kuo S, Boyko EJ, Magliano DJ. IDF Diabetes Atlas: Global, regional and country-level diabetes prevalence estimates for 2021 and projections for 2045. Diabetes Res Clin Pract. 2022 Jan;183:109119. doi: 10.1016/j.diabres.2021.109119. Epub 2021 Dec 6.

Reference Type BACKGROUND
PMID: 34879977 (View on PubMed)

Levine MJ. Empagliflozin for Type 2 Diabetes Mellitus: An Overview of Phase 3 Clinical Trials. Curr Diabetes Rev. 2017;13(4):405-423. doi: 10.2174/1573399812666160613113556.

Reference Type BACKGROUND
PMID: 27296042 (View on PubMed)

Vukadinovic D, Abdin A, Anker SD, Rosano GMC, Mahfoud F, Packer M, Butler J, Bohm M. Side effects and treatment initiation barriers of sodium-glucose cotransporter 2 inhibitors in heart failure: a systematic review and meta-analysis. Eur J Heart Fail. 2022 Sep;24(9):1625-1632. doi: 10.1002/ejhf.2584. Epub 2022 Jul 8.

Reference Type BACKGROUND
PMID: 35730422 (View on PubMed)

Other Identifiers

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SGLt2i in diabetic type 2

Identifier Type: -

Identifier Source: org_study_id

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