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Acute-to-chronic Glycemic Ratio (ACGR) is a Marker of DFUs .

NCT ID: NCT06725238

Last Updated: 2024-12-10

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

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-01

Study Completion Date

2024-11-10

Brief Summary

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Diabetic foot ulcers (DFUs) have resulted from peripheral arterial ischemia and peripheral neuropathy that are complicated with infections and amputation of the lower extremities. Uncontrolled glycemic status and significantly higher glycosylated hemoglobin (HbA1c) are associated with DFUs. This study aimed to assess the acute-to-chronic glycemic ratio (ACGR) in type 2 diabetes (T2D) with DFUs and compare it with those without DFUs, considering the relationships of this ratio with other indices that characterized the pathogenesis of T2D. This cross-sectional study was conducted on T2D with DFUs and non-DFUs. The primary outcome is ACGR. The secondary outcomes are indices related to the anthropometric, metabolic, and hematological variables.

Detailed Description

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DFUs are a macrovascular complication of diabetes mellitus resulting from peripheral artery disease and peripheral neuropathy that commonly affects the lower extremities. The DFUs are usually classified and scored according to the clinical findings. The ACGR is computed by dividing the acute (or current, or on admission in hospital) plasma glucose level by the chronic plasma glucose level calculated using the current (or on admission) HbA1c value.

Conditions

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Diabetic Foot Ulcer (DFU)

Keywords

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Diabetes foot ulcers Acute-to-chronic glycemic index Leucocyte-glucose index Triglyceride-glucose index

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Group I : patients presented with DFUs.

Participants who were referred to the consultant clinics at the Shar hospital were included if they had (i) a history of T2D irrespective of antidiabetic medicines or (ii) clinical and laboratory evidence of diabetic foot ulcers.

Acute-to-chronic glycemic ratio

Intervention Type OTHER

This ratio could be related to diabetic foot ulcer

Group II: patients who had T2D without DFUs

The participants have no previous history of diabetic foot ulcer or amputation. There were managed with oral anti-diabetes or occasionally with short term insulin therapy

No interventions assigned to this group

Interventions

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Acute-to-chronic glycemic ratio

This ratio could be related to diabetic foot ulcer

Intervention Type OTHER

Other Intervention Names

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Leucocyte glucose index Triglyceride-glucose index

Eligibility Criteria

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Inclusion Criteria

Type 2 Diabetes Clinical and laboratory diagnosis of diabetic foot ulcers Treatment with oral anti-diabetes +/- insulin

Exclusion Criteria

History of recent systemic infections Alcohol consumption Surgical procedures within 4 weeks Pregnant or breast-feeding women; Terminal illnesses.

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Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Diyala

OTHER

Sponsor Role lead

Responsible Party

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Marwan Salih Mohamad Al-Nimer

Professor of Clinical Pharmacology and Therapeutics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rawa A Ratha, M.Sc., PhD

Role: PRINCIPAL_INVESTIGATOR

College of Pharmacy, University of Sulaimani, Sulaymaniyah

Locations

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College of Medicine, University of Diyala

Baqubah, Diyālá, Iraq

Site Status

Countries

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Iraq

References

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Armstrong DG, Tan TW, Boulton AJM, Bus SA. Diabetic Foot Ulcers: A Review. JAMA. 2023 Jul 3;330(1):62-75. doi: 10.1001/jama.2023.10578.

Reference Type BACKGROUND
PMID: 37395769 (View on PubMed)

Related Links

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https://doi.org/10.5603/cd.99395

An article was studied the benefit of determination the stress hyperglycemia

Other Identifiers

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University of Sulaimani

Identifier Type: OTHER

Identifier Source: secondary_id

PH130-24

Identifier Type: -

Identifier Source: org_study_id