NCT06268977

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

February 21, 2024

Status Verified

February 1, 2024

Enrollment Period

1 year

First QC Date

January 17, 2024

Last Update Submit

February 17, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Effect of adding SGLTi on BP

    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

    compare the effect on BMI ( weight in kg and height in m2) in SGLTi receivers and non SGLTi receivers.

    Six months

Interventions

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.

Also known as: gliflozins or flozins

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult diabetic type 2patients

You may qualify if:

  • Adults (≥18 years)
  • both genders ( male and female)
  • type 2 diabetic patients

You may not qualify if:

  • history of svere hypoglycemia
  • patients with history of weight loss
  • Patients with history of recurrent UTI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 34879977BACKGROUND
  • 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.

    PMID: 27296042BACKGROUND
  • 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.

    PMID: 35730422BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sodium-Glucose Transporter 2 Inhibitors

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesHypoglycemic AgentsPhysiological Effects of Drugs

Central Study Contacts

Caroline Refaat labib, Resident

CONTACT

Mohammad Hasan AbdEllah-Alawi, Staff

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

January 17, 2024

First Posted

February 21, 2024

Study Start

March 1, 2024

Primary Completion

March 1, 2025

Study Completion

March 30, 2025

Last Updated

February 21, 2024

Record last verified: 2024-02