THE Effect of Tight Glycemic Control on Microvascular Complications in Type 2 Diabetes Mellitus

Not Applicable

Completed

• Conditions: Diabetes Mellitus

• Registration Number: NCT07049601
• Lead Sponsor: Ain Shams University

Brief Summary

The goal of this clinical trial is to learn the impact of tight versus less tight glycemic control on microvascular complications among Egyptian adults with uncontrolled T2DM. The main question it aims to answer is:

Does tight glycemic control improve or worsens microvascular complications of diabetes compared to less tight glycemic control?

Participants will:

* Be divided to two groups according to their HbA1c group A tight glycemic control and less tight glycemic control.

* Be followed for 6 months with clinical, laboratory, and fundoscopic evaluations performed at baseline and endpoint.

Detailed Description

Background: Tight glycemic control is widely promoted in the management of type 2 diabetes mellitus (T2DM) to reduce microvascular complications, yet the extent and speed of HbA1c reduction may paradoxically exacerbate certain outcomes.

Objective: To assess the impact of tight versus less tight glycemic control on microvascular complications among Egyptian adults with uncontrolled T2DM.

Methods: In this randomized controlled trial, 80 patients with poorly controlled T2DM (HbA1c \>7.5%) were randomized into two groups: Group A (tight control, HbA1c \<7.0%) and Group B (less tight control, HbA1c \<7.5%). Participants were followed for 6 months with clinical, laboratory, and fundoscopic evaluations performed at baseline and endpoint.

Study Timeline

• Study Start: 2022-05-11
• Primary Completion: 2023-10-01
• Study Completion: 2023-10-30
• Status Verified: 2025-06
• Study First Submitted: 2025-06-17
• Study First Submitted QC: 2025-06-25
• Last Update Submitted: 2025-06-25
• Study First Posted: 2025-07-03
• Last Update Posted: 2025-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Both sexes.
• Age 18-60years old.
• Patients diagnosed with Diabetes Mellitus (Type 2) according to American Diabetes Association (ADA) guidelines.
• Patients willing to participate after signing a written consent to be enrolled in the study after being explained to them in an interview.
• Diabetic patients with mild and moderate non proliferative diabetic retinopathy

Exclusion Criteria

• Patients with age above 60 or below 18 years old.
• Patients with severe non proliferative diabetic retinopathy up to advanced proliferative diabetic retinopathy.
• Patients diagnosed with type 1 DM.
• Patients with malignant tumours.
• Patients with end stage renal disease and end stage liver disease.
• Patients with history of myocardial infarction.
• Patients with recurrent attacks of hypoglycemia and hypoglycemia unawareness.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Effect of Tight Glycemic Control on Microvascular Complications (Retinopathy, neuropathy and Nephropathy) in Type 2 Diabetes Mellitus in 80 patients divided into two groups according to their HbA1c	18 months	80 patients with poorly controlled T2DM (HbA1c \>7.5%) were randomized into two groups according to their HbA1c: Group A (tight control, HbA1c \<7.0%) and Group B (less tight control, HbA1c \<7.5%). Participants were followed for 6 months with clinical, laboratory and fundoscopic evaluations performed at baseline and endpoint.

Trial Locations

Locations (1)

Ain Shams University Hospitals; 🇪🇬 Cairo, Abbasya, Egypt