Normoalbuminuric Chronic Kidney Disease in Type 2 Diabetes

Prevalence of Normoalbuminuric Chronic Kidney Disease and Its Risk Factors in Patients With Type 2 Diabetes Attending the Diabetes Center of Assiut University Hospital

• Assess the prevalence of normoalbuminuric CKD in Type 2 diabetes.
• Study the risk factors of normoalbuminuric CKD in patients with type 2 diabetes.

Study Overview

• Status: Unknown
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Diagnostic test: Albumin creatinine ratio

Detailed Description

Diabetes mellitus (DM) is considered a major cause of chronic kidney disease (CKD), where about 40% of the diabetics develop diabetic kidney disease (DKD) resulting in albuminuria, reduction of glomerular filtration rate (GFR), or both .

Albuminuria was widely considered the first clinical sign of DKD, therefore, it has been used as a screening test for DKD. However, recent studies showed that a significant number of T2DM patients have a decreased GFR with normoalbuminuria, known as non-albuminuric DKD (NA-DKD) .

The use of albuminuria as an early marker of DKD onset or progression requires a careful interpretation because in diabetics, albuminuria has a great tendency to return to normal spontaneously. Evidence based studies reported that about 18-51 percent of T2DM (followed during 2-10 years) present first with albuminuria turn to normoalbuminurics spontaneously during the period of follow-up .

The United Kingdom Prospective Diabetes Study (UKPDS) reported that some diabetics pass directly from a normoalbuminuria to renal insufficiency (0.1% per year) .

Albuminuria as a marker of glomerular lesion progression has some limitations because of its intra-patient variability and possibility of spontaneous regress (in >50% of the patients with low levels of albuminuria), in contrast with GFR that has low variability and infrequent improvement .

Few of T2DM patients are presented without significant proteinuria but present with renal insufficiency and developed DKD (i.e., estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2), which was defined as normoalbuminuric diabetic kidney disease (NADKD) or diabetic kidney disease without proteinuria where albuminuria does not associate with impairment of kidney function .

The ADA criteria for diagnosis of DKD now involve the presence of eGFR < 60 mL/min/1.73 m2 or the presence of UAE > 30 mg/24 h. In patients with NADKD, the risk factors include obesity, hypertension, high TG levels, sex, smoking, poor glycemic control, and glomerular hyperfiltration which play a role in nephrosclerosis. Macroangiopathy is also prevalent in patients with NADKD .

Intrarenal arteriosclerosis is the main cause of renal impairment in type 2 diabetic patients independent of albuminuria, and this partly cause eGFR decline in these patients. Several studies also suggest that decline in renal function is mainly due to interstitial injury (a pathological change in DN) as compared with glomerular injury .

Normoalbuminuria is associated with Diabetic kidney disease (DKD), which is the commonest cause of end-stage renal disease (ESRD) all over the world. The clinical manifestations of DKD consist of a progressive increase in albuminuria and a decline in estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2. Hence, the diagnosis of DKD in patients with declining renal function without albuminuria is more difficult. The decline of renal function is slower in normoalbuminuria .

Tthe majority of patients with DKD had albuminuria, but a significant proportion had the normoalbuminuric renal impairment (46.6%) . The prevalence of NADKD ranges globally from 14.29 to 56.6% among diabetic patients with different ethnicities .

The prevalence of NADKD is about 23.3% to 56.6% in T2DM patients with a decline in the renal function presented with normal albuminuria . However, the prevalence at which the patients develop normoalbuminuric renal impairment in Type 2 diabetes are not completely defined.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Martina Michael Wadae, master; Phone Number: 01221277260; Email: martina.michael13@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with type 2 diabetes attending diadetes center of Assiut University

Description

Inclusion Criteria:

• Patients age >18 -65 years .
• Diagnosed previously with T2DM.

Exclusion Criteria:

• Patients with type 1 diabetes,

  • Patients with secondary diabetes,
  • Patients with gestational diabetes
  • Patients with severe acute or chronic hepatic or cardiac diseases.
  • Patients with Past or present history of malignancy .
  • Patients with in need for renal replacement therapy.
  • Patients with other probable causes for CKD.
  • Patients with an active urinary sediment and nephrotic - range proteinuria .

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with type 2 diabetes; patients with type 2 diabetes and have normal range of albumine in urine and decline in renal functions	Diagnostic test: Albumin creatinine ratio; normal range of albumin in urine in patients with type 2 diabetes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of Normoalbuminuric chronic kidney disease	The required sample size(200 patients) has been calculated using the EPI info version which achieve power of study 80%.	Baseline

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2020
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: March 12, 2020
• First Submitted That Met QC Criteria: May 30, 2020
• First Posted (Actual): June 2, 2020

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 3, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: normoalbuminuric CKD in DM2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No