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Diabetic Chronic Kidney Disease PatientsNCT07354958

Impact of Diabetes-Related Metabolic Derangements on Clinical Outcomes in Hospitalized Patients With Chronic Kidney Disease

An observational study of Diabetic Chronic Kidney Disease Patients, run by Sohag University at 1 site in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This observational study will collect clinical and laboratory information from hospitalized patients with chronic kidney disease to identify diabetes mellitus and selected metabolic findings during hospitalization Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Chronic Kidney Disease Patients
What is being tested?
Primary aim 1. To assess the frequency of diabetes mellitus among hospitalized CKD patients. 2. To evaluate the frequency and types of metabolic abnormalities (e.g., hypoglycemia, diabetic ketoacidosi
How many people
200 participants
Where
1 siteEgypt
Study dates
1 Jan 2026to 31 Aug 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: A) Inclusion criteria: * Age ≥18 years. * Known CKD (baseline eGFR <60 mL/min/1.73 m² for ≥3 months) OR documented CKD stage 3-5 by prior records. * Hospitalized for any medical reason. * Consent provided. B) Exclusion criteria: * Acute single episode of reversible AKI with previously normal renal function (no established CKD). * Admission for palliative care /expected survival <24 hours. * Pregnancy. C) Patient groups (for analysis): Diabetes status: * Diabetic CKD (known diagnosis or on antidiabetic therapy prior to admission). * Non-diabetic CKD. D) Subgroups / Diabetic patient group: Metabolic derangement categories 1. Acute hyperglycemia * Diabetic ketoacidosis (DKA) /hyperosmolar hyperglycemic state (HHS) * Patients without DKA or HHS 2. Hypoglycemia * Hypoglycemia: any blood glucose <70 mg/dL (and severe <40 mg/dL). * Without Hypoglycemia episodes 3. Metabolic acidosis arterial or venous HCO₃- <20 mmol/L or pH <7.35 with anion gap >12 as appropriate.

Who may be able to join

  • Age greater than or equal to 18 years
  • Known chronic kidney disease, defined as baseline estimated glomerular filtration rate less than 60 milliliters per minute per 1.73 square meters for at least 3 months, or documented chronic kidney disease stage 3 to 5 by prior medical records
  • Hospitalized for any medical reason
  • Consent provided

Who cannot join

  • Acute single episode of reversible acute kidney injury with previously normal renal function (no established chronic kidney disease)
  • Admission for palliative care or expected survival less than 24 hours
  • Pregnancy

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mohamed Mahmoud Rashad, Master Degree contact

01153640803

mohammed_rashad_post@med.sohag.edu.eg

Mahmoud Ibrahim Yousef, Associate Professor contact

01065964083

mahmoudibrahim@med.sohag.edu.eg

Egypt1 site
  • Sohag University Hospital

    Sohag

    Mohamed Mahmoud Rashad, Master Degree, 01153640803, mohammed_rashad_post@med.sohag.edu.eg

    Mahmoud Ibrahim Yousef, Associate Professor, mahmoudibrahim@med.sohag.edu.eg

Other trials in Egypt

About this study

This observational study will collect clinical and laboratory information from hospitalized patients with chronic kidney disease to identify diabetes mellitus and selected metabolic findings during hospitalization

Read the detailed description

Hospitalized adult patients with chronic kidney disease will be included in this observational study. Information routinely recorded during hospitalization will be collected. This information will include the presence of diabetes mellitus and laboratory values related to blood glucose levels, electrolyte levels, and acid base balance. No study related interventions will be performed.

Being tested
Primary aim 1. To assess the frequency of diabetes mellitus among hospitalized CKD patients. 2. To evaluate the frequency and types of metabolic abnormalities (e.g., hypoglycemia, diabetic ketoacidosi

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Primary aim 1. To assess the frequency of diabetes mellitus among hospitalized CKD patients. 2. To evaluate the frequency and types of metabolic abnormalities (e.g., hypoglycemia, diabetic ketoacidosiBehavioural

    Primary aim

    1. To assess the frequency of diabetes mellitus among hospitalized CKD patients.
    2. To evaluate the frequency and types of metabolic abnormalities (e.g., hypoglycemia, diabetic ketoacidosis/ hyperosmolar states, metabolic acidosis, dyslipidemia, electrolyte imbalance) in diabetic CKD patients.

    Secondary aim

    1. To evaluate the association between diabetes and diabetes-related metabolic derangements in-hospital adverse outcomes (major cardiovascular events, ICU admission, length of stay, infection rate, need for dialysis and mortality) among hospitalized patients with CKD.
Study groups in NCT07354958
Study groupRoleWhat they receive
1. Diabetic CKD (known diagnosis or on antidiabetic therapy prior to admission). 2. Non-diabetic CKDNot described
Receives: Behavioral: Primary aim 1. To assess the frequency of diabetes mellitus among hospitalized CKD patients. 2. To evaluate the frequency and types of metabolic abnormalities (e.g., hypoglycemia, diabetic ketoacidosi

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. In-Hospital Mortality

    Patient death from any cause occurring during the hospitalization period

    Measured: From admission until hospital discharge, assessed over a 6-month study enrollment period.

  2. New Requirement for In-Hospital Renal Replacement Therapy

    Initiation of dialysis in a patient who was not receiving renal replacement therapy at the time of hospital admission

    Measured: From admission until hospital discharge, assessed over a 6-month study enrollment period.

  3. Incidence of a Major In-Hospital Cardiovascular Composite Event

    A composite outcome defined as the first occurrence of any of the following during the hospitalization: myocardial infarction, stroke, or new-onset heart failure requiring inotropic support or mechanical ventilation

    Measured: From admission until hospital discharge, assessed over a 6-month study enrollment period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2026
  2. Study start1 Jan 2026 (estimated)
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion31 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07354958
Sponsor's protocol ID
Soh-Med--25-12-5MS
Status last verified
Jan 2026
First submitted
25 Dec 2025
Last updated
21 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetic Chronic Kidney Disease Patients, run by Sohag University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mohamed Mahmoud Rashad, Master Degree (01153640803, mohammed_rashad_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-Hospital Mortality (time frame: From admission until hospital discharge, assessed over a 6-month study enrollment period.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.

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