Effect of Novel Antidiabetic Drug Combined With Angiotensin Receptor/Neprilysin Inhibitor on Urinary Protein

NCT ID: NCT05922852

Last Updated: 2023-06-28

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

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-02-28

Brief Summary

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The purpose of this study is to determine whether the combination of SGLT2i and ARNI in type 2 diabetic patients with combined albuminuria could reduce urinary protein more significantly than single agent.

Detailed Description

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This project is a single-center retrospective cohort study to obtain the biochemical index levels of urinary albumin creatinine ratio, urinary protein creatinine ratio, blood renal function, blood lipids, and blood glucose at the immediate, 3rd, 6th, and 12th month of cohort inclusion in each group of patients.

Conditions

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Type 2 Diabetes Antidiabetic Drugs

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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SGLT2i+ARNI

patients in this group received SGLT2i combined with ARNI medication。

No interventions assigned to this group

SGLT2i only

patients in this group received SGLT2i medication only。

No interventions assigned to this group

ARNI only

patients in this group received ARNI medication only。

No interventions assigned to this group

control

patients in this group received neither SGLT2i nor ARNI。

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age greater than or equal to 18 years
* Clinical diagnosis of type 2 diabetes mellitus
* Immediate urine albumin creatinine ratio greater than 30mg/g
* Signed informed consent and available for follow-up

Exclusion Criteria

* severe renal insufficiency, i.e. eGFR ≤ 30ml/min/1.75m2
* clinical diagnosis of various acute and chronic urinary tract infections
* combined with various serious infectious diseases
* combined with acute complications of diabetes mellitus
* end-stage malignancy
* pregnancy and lactation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking University Third Hospital, Beijing, Beijing 100191

Beijing, Beijing Municipality, China

Site Status RECRUITING

Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Dan Zhu

Role: primary

+8613810103532 ext. +8613810103532

Dan Zhu

Role: primary

+8613810103532 ext. +8613810103532

Tingcui Li

Role: backup

+8618801236290 ext. +8618801236290

References

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Xu L, Chen B, Zhang H, Zhu D. Combined effects of sodium-glucose cotransporter 2 inhibitor and angiotensin receptor-neprilysin inhibitor on renal function in cardiovascular disease patients with type 2 diabetes mellitus: a retrospective cohort study. Front Endocrinol (Lausanne). 2024 Jan 11;14:1326611. doi: 10.3389/fendo.2023.1326611. eCollection 2023.

Reference Type DERIVED
PMID: 38274236 (View on PubMed)

Other Identifiers

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M2023228

Identifier Type: -

Identifier Source: org_study_id

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