Skip to main content
OpenTrials
Completed

NCT Number: NCT07049601

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University Hospitals

Cairo, Abbasya, 123, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Insulin Therapy

Other

The effect of this intervention on HbA1c leading to either tight glycemic control HbA1c less than 7% or less tight glycemic control HbA1c less than 7.5%

Other names: oral antidiabetics, lifestyle and nutrition education

Antidiabetic therapy, lifestyle modification

Other

Individualized adjustments in antidiabetic therapy, lifestyle modification, and monthly clinical follow-up.

Primary outcomes

  1. 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Effect of Tight Glycemic Control on Microvascular Complications in Type 2 Diabetes Mellitus: A Randomized Controlled Trial in an Egyptian Cohort

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 3, 2025
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.