Diabete MellitusNCT05147818

Risk Factors for Acute Kidney Injury in Diabetic Patients

An observational study of Diabete Mellitus, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

incidence of AKI in diabetic patients seems to be influenced by multiple risk Factors like severe infections, elderly, poor diabetic control, previous AKI, chronic kidney disease and drugs like SGLT2-I increase risk of AKI in diabetic patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabete Mellitus
What is being tested?: CBC ,renal function tests , fundus Examination
How many people: 400 participants
Where: No sites listed yet
Study dates: 1 Dec 2021to 30 Dec 2023
Phase: Observational
Are there results?: None posted in the registry

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
Adult, Older adult

Study population: patients aged from 18 year and older Diabetic patients.

Who may be able to join

-
200 Diabetic patients of 18 year and older (either type 1or 2) presented by AKI based on KIDIGO Definition \& Staging. KDIGO definition of AKI: Increase in serum creatinine by ≥0.3 mg/dL (≥26.5 µmol/L) within 48 h, or Increase in serum creatinine to ≥1.5 times baseline that is known or presumed to have occurred within the prior 7 days, or Urine volume <0.5 mL/kg/h for 6 h.
KDIGO staging of AKI: (1) stage 1: Serum creatinine 1.5-1.9 × baseline or ≥0.3 mg/dL (≥26.5 µmol/L) increase / Urine output <0.5 mL/kg/h for 6-12 h (2) stage 2; Serum creatinine 2.0-2.9 × baseline / Urine output <0.5 mL/kg/h for ≥12 h (3) stage 3: Serum creatinine 3.0 × baseline, increase in serum creatinine to ≥4.0 mg/dL (≥353.6 µmol/L), initiation of renal replacement therapy, or, in patients <18 years, decrease in eGFR to <35 mL/min per 1.73 m2 / Urine output <0.3 mL/kg/h for ≥24 h or anuria for ≥12 h .
Inclusion criteria for matched controls 200 Diabetic patients of 18 year and older with no AKI (either type 1or 2)

Who cannot join

Non-Diabetic patients with AKI
Diabetic patients with:
HBS Ag, HCV, HIV
Active Lupus
Active Malignancy
Acute or Chronic Liver Disease
Acute poisoning

About this study

Read the detailed description

The incidence and prevalence of diabetes mellitus (DM) have increased over the last 20 years. The defining feature of diabetes mellitus (DM) is the presence of hyperglycaemia . mostly due to the progressively increasing prevalence of obesity and the metabolic syndrome, Current prevalence of DM worldwide is estimated to be about 390 million people . The Cardiovascular complications increase morbidity and mortality in diabetic patients. About 40% of end-stage renal disease on regular dialysis are diabetic . Acute kidney injury (AKI) Is a fundamental problem in hospitalized patients; its incidence has been reaching 20% in middle-Europe . About 50% of patients presented with AKI are found to be diabetic ; which may indicate a direct relationship between the two conditions. In 2012, a clinical practice guideline published by Kidney Disease: Improving Global Outcomes (KDIGO) provided a unifying definition and staging system for AKI . On the other hand, incidence of AKI in diabetic patients seems to be influenced by multiple risk Factors like severe infections, elderly, poor diabetic control, previous AKI, chronic kidney disease and drugs like SGLT2-I increase risk of AKI in diabetic patients. We aim in this study to identify the most common risk factors for AKI in diabetic patients and how those risk factors affect morbidity and mortality in patients with DM who developed AKI.

Conditions: Diabete Mellitus
Being tested: CBC ,renal function tests , fundus Examination
Medical subject headings: Diabetes Mellitus

What participants receive

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

CBC ,renal function tests , fundus ExaminationOther
Also called ECG
Laboratory investigations

Study groups in NCT05147818
Study group	Role	What they receive
Cases		200 Diabetic patients of 18 year and older (either type 1or 2) presented by AKI based on KIDIGO Definition \& Staging. KDIGO definition of AKI: Increase in serum creatinine by ≥0.3 mg/dL (≥26.5 µmol/L) within 48 h, or Increase in serum creatinine to ≥1.5 times baseline that is known or presumed to have occurred within the prior 7 days, or Urine volume <0.5 mL/kg/h for 6 h. KDIGO staging of AKI: (1) stage 1: Serum creatinine 1.5-1.9 × baseline or ≥0.3 mg/dL (≥26.5 µmol/L) increase / Urine output <0.5 mL/kg/h for 6-12 h (2) stage 2; Serum creatinine 2.0-2.9 × baseline / Urine output <0.5 mL/kg/h for ≥12 h (3) stage 3: Serum creatinine 3.0 × baseline, increase in serum creatinine to ≥4.0 mg/dL (≥353.6 µmol/L), initiation of renal replacement therapy, or, in patients <18 years, decrease in eGFR to <35 mL/min per 1.73 m2 / Urine output <0.3 mL/kg/h for ≥24 h or anuria for ≥12 h . Receives: Other: CBC ,renal function tests , fundus Examination
Controls		200 Diabetic patients of 18 year and older with no AKI (either type 1or 2) Matched to controls in age ,sex

What is being measured

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

Identify risk factors for Acute kidney injury in diabetic patients
Identify risk factors for Acute kidney injury in d iabetic patients
Measured: 2 years

Timeline

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

1 Dec 202130 Dec 2023

First posted7 Dec 2021
Study start1 Dec 2021 (estimated)
Primary completion30 Dec 2023 (estimated)
Study completion30 Dec 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Diabete MellitusStudies of the same condition, open and under way.
More trials run by Assiut 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: Case-control
Time perspective: Retrospective
Enrolment: 400 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05147818
Sponsor's protocol ID: SSA
Status last verified: Nov 2021
First submitted: 27 Nov 2021
Last updated: 7 Dec 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

American Diabetes Association. (2) Classification and diagnosis of diabetes. Diabetes Care. 2015 Jan;38 Suppl:S8-S16. doi: 10.2337/dc15-S005. No abstract available.
PubMed 25537714
Aziz Z, Absetz P, Oldroyd J, Pronk NP, Oldenburg B. A systematic review of real-world diabetes prevention programs: learnings from the last 15 years. Implement Sci. 2015 Dec 15;10:172. doi: 10.1186/s13012-015-0354-6.
PubMed 26670418
Mima A. Diabetic nephropathy: protective factors and a new therapeutic paradigm. J Diabetes Complications. 2013 Sep-Oct;27(5):526-30. doi: 10.1016/j.jdiacomp.2013.03.003. Epub 2013 Apr 22.
PubMed 23619194
Bienholz A, Wilde B, Kribben A. From the nephrologist's point of view: diversity of causes and clinical features of acute kidney injury. Clin Kidney J. 2015 Aug;8(4):405-14. doi: 10.1093/ckj/sfv043. Epub 2015 Jul 9.
PubMed 26251707
DeFronzo RA, Reeves WB, Awad AS. Pathophysiology of diabetic kidney disease: impact of SGLT2 inhibitors. Nat Rev Nephrol. 2021 May;17(5):319-334. doi: 10.1038/s41581-021-00393-8. Epub 2021 Feb 5.
PubMed 33547417

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

All Diabete Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Risk Factors for Acute Kidney Injury in Diabetic Patients
ClinicalTrials.gov ID: NCT05147818
Acronym / sponsor ID: SSA
Conditions: Diabete Mellitus
Study type: Observational
Recruitment status: Unknown status
Enrolment: 400 participants (estimated)
Lead sponsor: Assiut UniversityUniversity, hospital or other
Study start: 1 Dec 2021 (estimated)
Primary completion: 30 Dec 2023 (estimated)
Study completion: 30 Dec 2023 (estimated)
First posted: 7 Dec 2021 (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.

Detailed description

Study design

Observational model: Case-control
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Cases	–	Other: CBC ,renal function tests , fundus Examination200 Diabetic patients of 18 year and older (either type 1or 2) presented by AKI based on KIDIGO Definition \& Staging. KDIGO definition of AKI: Increase in serum creatinine by ≥0.3 mg/dL (≥26.5 µmol/L) within 48 h, or Increase in serum creatinine to ≥1.5 times baseline that is known or presumed to have occurred within the prior 7 days, or Urine volume <0.5 mL/kg/h for 6 h. KDIGO staging of AKI: (1) stage 1: Serum creatinine 1.5-1.9 × baseline or ≥0.3 mg/dL (≥26.5 µmol/L) increase / Urine output <0.5 mL/kg/h for 6-12 h (2) stage 2; Serum creatinine 2.0-2.9 × baseline / Urine output <0.5 mL/kg/h for ≥12 h (3) stage 3: Serum creatinine 3.0 × baseline, increase in serum creatinine to ≥4.0 mg/dL (≥353.6 µmol/L), initiation of renal replacement therapy, or, in patients <18 years, decrease in eGFR to <35 mL/min per 1.73 m2 / Urine output <0.3 mL/kg/h for ≥24 h or anuria for ≥12 h .
Controls	–	–200 Diabetic patients of 18 year and older with no AKI (either type 1or 2) Matched to controls in age ,sex

Who may qualify

Ages: 18 years and older
Sex: All
Age groups: Adult, Older adult
Study population: patients aged from 18 year and older Diabetic patients.

Key inclusion criteria (4 listed)

-
200 Diabetic patients of 18 year and older (either type 1or 2) presented by AKI based on KIDIGO Definition \& Staging. KDIGO definition of AKI: Increase in serum creatinine by ≥0.3 mg/dL (≥26.5 µmol/L) within 48 h, or Increase in serum creatinine to ≥1.5 times baseline that is known or presumed to have occurred within the prior 7 days, or Urine volume <0.5 mL/kg/h for 6 h.
KDIGO staging of AKI: (1) stage 1: Serum creatinine 1.5-1.9 × baseline or ≥0.3 mg/dL (≥26.5 µmol/L) increase / Urine output <0.5 mL/kg/h for 6-12 h (2) stage 2; Serum creatinine 2.0-2.9 × baseline / Urine output <0.5 mL/kg/h for ≥12 h (3) stage 3: Serum creatinine 3.0 × baseline, increase in serum creatinine to ≥4.0 mg/dL (≥353.6 µmol/L), initiation of renal replacement therapy, or, in patients <18 years, decrease in eGFR to <35 mL/min per 1.73 m2 / Urine output <0.3 mL/kg/h for ≥24 h or anuria for ≥12 h .
Inclusion criteria for matched controls 200 Diabetic patients of 18 year and older with no AKI (either type 1or 2)

Key exclusion criteria (7 listed)

Non-Diabetic patients with AKI
Diabetic patients with:

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
CBC ,renal function tests , fundus ExaminationAlso: ECGLaboratory investigations	Other	Cases

Primary outcome

Identify risk factors for Acute kidney injury in diabetic patients
Time frame: 2 years
Identify risk factors for Acute kidney injury in d iabetic patients

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2021.
Background: PubMed 25537714American Diabetes Association. (2) Classification and diagnosis of diabetes. Diabetes Care. 2015 Jan;38 Suppl:S8-S16. doi: 10.2337/dc15-S005. No abstract available.
Background: PubMed 26670418Aziz Z, Absetz P, Oldroyd J, Pronk NP, Oldenburg B. A systematic review of real-world diabetes prevention programs: learnings from the last 15 years. Implement Sci. 2015 Dec 15;10:172. doi: 10.1186/s13012-015-0354-6.
Background: PubMed 23619194Mima A. Diabetic nephropathy: protective factors and a new therapeutic paradigm. J Diabetes Complications. 2013 Sep-Oct;27(5):526-30. doi: 10.1016/j.jdiacomp.2013.03.003. Epub 2013 Apr 22.
Background: PubMed 26251707Bienholz A, Wilde B, Kribben A. From the nephrologist's point of view: diversity of causes and clinical features of acute kidney injury. Clin Kidney J. 2015 Aug;8(4):405-14. doi: 10.1093/ckj/sfv043. Epub 2015 Jul 9.
Background: PubMed 33547417DeFronzo RA, Reeves WB, Awad AS. Pathophysiology of diabetic kidney disease: impact of SGLT2 inhibitors. Nat Rev Nephrol. 2021 May;17(5):319-334. doi: 10.1038/s41581-021-00393-8. Epub 2021 Feb 5.
Individual participant dataSharing planned: No

Related trials for Diabete Mellitus

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Diabete Mellitus, run by Assiut University.

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 7 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: status not confirmed, as of the sponsor's last update on 7 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Identify risk factors for Acute kidney injury in diabetic patients (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05147818, which also lists 5 linked publications.

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 7 Dec 2021.