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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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
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.
- Conditions
- Diabetic Chronic Kidney Disease Patients
- 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
- To assess the frequency of diabetes mellitus among hospitalized CKD patients.
- 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
- 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 group | Role | What they receive |
|---|---|---|
| 1. Diabetic CKD (known diagnosis or on antidiabetic therapy prior to admission). 2. Non-diabetic CKD | Not 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.
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.
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.
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.
- First posted21 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Chronic Kidney Disease PatientsStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mahmoud Rashad, Sohag University
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Diabetes-Related Metabolic Derangements on Clinical Outcomes in Hospitalized Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT07354958
- Acronym / sponsor ID
- Soh-Med--25-12-5MS
- Conditions
- Diabetic Chronic Kidney Disease Patients
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1. Diabetic CKD (known diagnosis or on antidiabetic therapy prior to admission). 2. Non-diabetic CKD | – | 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 ketoacidosiPrimary 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. | Behavioural | 1. Diabetic CKD (known diagnosis or on antidiabetic therapy prior to admission). 2. Non-diabetic CKD |
Primary outcome
In-Hospital Mortality
Time frame: From admission until hospital discharge, assessed over a 6-month study enrollment period.
Patient death from any cause occurring during the hospitalization period
New Requirement for In-Hospital Renal Replacement Therapy
Time frame: From admission until hospital discharge, assessed over a 6-month study enrollment period.
Initiation of dialysis in a patient who was not receiving renal replacement therapy at the time of hospital admission
Incidence of a Major In-Hospital Cardiovascular Composite Event
Time frame: From admission until hospital discharge, assessed over a 6-month study enrollment period.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.