ALLOPURINOL AND LISINOPRIL FOR DIABETIC KIDNEY PROTECTION: A COMPARATIVE STUDY IN NORMOURICEMIC TYPE 2 DIABETICS

NCT07177898 | Completed DMC

• 1 other identifier: 163/RC/KEMU
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial was conducted at the Department of Medicine and Diabetes of Mayo Hospital/King Edward Medical University, Lahore, over one year. A total of 80 patients with type 2 diabetes and normal serum uric acid were randomly assigned to two groups: Group A received allopurinol with lisinopril, and Group B received lisinopril alone. Patients were monitored every three months for serum creatinine, spot urine albumin, and serum uric acid levels. The primary endpoint was a \>300 mg/L increase in urine albumin from baseline. Blood pressure was managed with agents other than ACE inhibitors if required.

Conditions

Diabetic Kidney Disease (DKD)

Keywords

Diabetic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Urinary Albumin

  The primary endpoint was a \>300 mg/L increase in urine albumin from baseline.

  3 months

Study Arms (2)

Group A

ACTIVE COMPARATOR

Group A received allopurinol with lisinopril

Drug: Allopurinol

Group B

NO INTERVENTION

Group B received Lisinopril alone

Interventions

Allopurinol DRUG

Group A received allopurinol with lisinopril, and Group B received lisinopril alone

Group A

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with type 2 diabetes mellitus on oral hypoglycemic agents, serum creatinine levels less than 1.1 mg/dL, and serum uric acid levels between 5.5-6.5 mg/dL for males and 5-6 mg/dL for females

You may not qualify if:

• patients with tumor lysis syndrome, chronic kidney disease from other causes (e.g., hypertension, glomerulonephritis, polycystic kidney disease, or hydronephrosis), those on medications that could cause hyperuricemia (such as thiazide diuretics) or those on drugs that may induce proteinuria (e.g., NSAIDs, cyclosporine, penicillamine, or gold). Patients with uric acid levels exceeding 7 mg/dL were also excluded

Sponsors & Collaborators

• Narowal Medical College: lead
• King Edward Medical University: collaborator

Study Sites (1)

King Edward Medical University

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

• Robinson RL, et al. Allopurinol reduces proteinuria in diabetic nephropathy: A randomized controlled trial. Diabetologia. 2020;63(6):1217-1224.

  BACKGROUND

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

Allopurinol

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 17, 2025
• Study Start: May 14, 2023
• Primary Completion: September 23, 2024
• Study Completion: November 18, 2024
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)