DiabeticNCT06815224
The Role of Perirenal Fat As Predictor in Diabetic Nephropathy
An observational study of Diabetic, run by Assiut University.
Trial summary
1 detect the relationship between perirenal fat thickness (PrFT) and estimated glomerular filtration rate (eGFR) in patients with type 2 diabetes (T2DM). 2)Explored the relationship between PRF thickness and the onset and progression of albuminuria in patients with diabetes 3)Evaluate associations between… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic
- What is being tested?
- Sonar
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 31 Dec 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Follow up patient is T2DM
Who may be able to join
- Patients with T2DM aged 18-70 were included in this study. T2DM was diagnosed according to American Diabetes Association (ADA) ,Data collection will obtained over one year from October 2024 to October 2025.
- Clinical diagnosis of Alzheimer's Disease Must be able to swallow tablets
Who cannot join
- b. Exclusion criteria:
- patients with a history of malignancy and surgical trauma.
- patients diagnosed with nondiabetic renal diseases
- Patients with renal replacement therapy (renal transplant or dialysis patients), renal morphological abnormalities (difference in kidney length between the two cm, solitary kidney or multiple kidneys, congenital kidney abnormalities, polycystic kidney, and hydronephrosis), liver cirrhosis.
- Insulin dependent diabetes
- Thyroid disease
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Marina Sobhy Masoud, Resident of Nephrology contact
About this study
1 detect the relationship between perirenal fat thickness (PrFT) and estimated glomerular filtration rate (eGFR) in patients with type 2 diabetes (T2DM).
2)Explored the relationship between PRF thickness and the onset and progression of albuminuria in patients with diabetes 3)Evaluate associations between obesity-related markers with albuminuria and advanced kidney disease in patients with type 2 diabetes mellitus (DM)
Read the detailed description
Diabetic kidney disease (DKD) is the most frequent and severe complication of diabetes mellitus (DM). Approximately 40% of patients with diabetes present with proteinuria and renal dysfunction and DKD reportedly account for 50% of newly diagnosed end-stage renal disease (ESRD) . Metabolic disorders caused by hyperglycemia in DKD can lead to both glucose and lipid metabolism disorders. Not only hyperglycemia, many factors including obesity have been reported to be risk factors for diabetic kidney disease .
Body mass index (BMI) and waist circumference (WC), widely used as obesity indexes, have been proved to aggravate the development of CKD in different subsets of patients , but BMI and WC lack detailed information about the distribution of body fat. Body fat is now usually divided into subcutaneous fat and visceral fat according to the anatomical and physiological functions of fat deposition . Visceral fat has been thought to be associated with the progression of CKD .
Recently, new anthropometric and imaging methods have been used to assess visceral fat in clinical practice and research. Perirenal fat is a fat pad surrounding the kidneys, located between the renal fibrous membrane and the renal fascia in the retroperitoneal space .PRF has been reported to be associated with renal disease in various ways.Additionally, it has been proved that renal sinus fat was associated with an increased risk of CKD in general subjects through inflammatory signaling
- Conditions
- Diabetic
- Being tested
- Sonar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonarDevice
Abdominal sonar
What is being measured
The primary outcome is the main question the study is designed to answer.
the thickness of preirenal fat in diabetic patients
Follow up the patient with sonar to detect early changes in perirenal fat in diabetic patient. perirenal fat is the thickness of the fat capsule along the long axis of the kidney, and pararenal fat was the thickness of the fat layer measured between the medial surface of abdominal muscle tissue and the renal fascia.
Measured: Basaline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabeticStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Sobhy Gerges, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06815224
- Sponsor's protocol ID
- Perirenal fat in diabetic
- Status last verified
- Feb 2025
- First submitted
- 26 May 2024
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Perirenal Fat As Predictor in Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT06815224
- Acronym / sponsor ID
- Perirenal fat in diabetic
- Conditions
- Diabetic
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Feb 2025 (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.
1 detect the relationship between perirenal fat thickness (PrFT) and estimated glomerular filtration rate (eGFR) in patients with type 2 diabetes (T2DM).
2)Explored the relationship between PRF thickness and the onset and progression of albuminuria in patients with diabetes 3)Evaluate associations between obesity-related markers with albuminuria and advanced kidney disease in patients with type 2 diabetes mellitus (DM)
Detailed description
Diabetic kidney disease (DKD) is the most frequent and severe complication of diabetes mellitus (DM). Approximately 40% of patients with diabetes present with proteinuria and renal dysfunction and DKD reportedly account for 50% of newly diagnosed end-stage renal disease (ESRD) . Metabolic disorders caused by hyperglycemia in DKD can lead to both glucose and lipid metabolism disorders. Not only hyperglycemia, many factors including obesity have been reported to be risk factors for diabetic kidney disease .
Body mass index (BMI) and waist circumference (WC), widely used as obesity indexes, have been proved to aggravate the development of CKD in different subsets of patients , but BMI and WC lack detailed information about the distribution of body fat. Body fat is now usually divided into subcutaneous fat and visceral fat according to the anatomical and physiological functions of fat deposition . Visceral fat has been thought to be associated with the progression of CKD .
Recently, new anthropometric and imaging methods have been used to assess visceral fat in clinical practice and research. Perirenal fat is a fat pad surrounding the kidneys, located between the renal fibrous membrane and the renal fascia in the retroperitoneal space .PRF has been reported to be associated with renal disease in various ways.Additionally, it has been proved that renal sinus fat was associated with an increased risk of CKD in general subjects through inflammatory signaling
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Follow up patient is T2DM
Key inclusion criteria (2 listed)
- Patients with T2DM aged 18-70 were included in this study. T2DM was diagnosed according to American Diabetes Association (ADA) ,Data collection will obtained over one year from October 2024 to October 2025.
- Clinical diagnosis of Alzheimer's Disease Must be able to swallow tablets
Key exclusion criteria (6 listed)
- b. Exclusion criteria:
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 |
|---|---|---|
| SonarAbdominal sonar | Device | – |
Primary outcome
the thickness of preirenal fat in diabetic patients
Time frame: Basaline
Follow up the patient with sonar to detect early changes in perirenal fat in diabetic patient. perirenal fat is the thickness of the fat capsule along the long axis of the kidney, and pararenal fat was the thickness of the fat layer measured between the medial surface of abdominal muscle tissue and the renal fascia.
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 7 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Diabetic
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
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
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.
Marina Sobhy Masoud, Resident of Nephrology contact
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic, 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 2 inclusion and 6 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 7 Feb 2025. 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?
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 Marina Sobhy Masoud, Resident of Nephrology (093 2346730 ext. 01223602270, marinasobhygerges@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the thickness of preirenal fat in diabetic patients (time frame: Basaline). 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 7 Feb 2025.