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

NCT ID: NCT07049601

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-11
• Study Completion Date: 2023-10-30

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Tight glycemic control

Patients received treatment through insulin therapy, oral hypoglycemics and lifestyle and nutrition education to achieve tight glycemic control with HbA1c less than 7%

Group Type: ACTIVE_COMPARATOR

Insulin Therapy

Intervention Type: 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%

Antidiabetic therapy, lifestyle modification

Intervention Type: OTHER

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

Less tight glycemic control

Patients received treatment through insulin therapy, oral hypoglycemics and lifestyle and nutrition education to achieve tight glycemic control with HbA1c less than 7.5

Group Type: ACTIVE_COMPARATOR

Insulin Therapy

Intervention Type: 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%

Antidiabetic therapy, lifestyle modification

Intervention Type: OTHER

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

Interventions

Insulin Therapy

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%

Intervention Type: OTHER

Antidiabetic therapy, lifestyle modification

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

Intervention Type: OTHER

Other Intervention Names

oral antidiabetics; lifestyle and nutrition education

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Ola Mohamed Moustafa Shaheen

Assistant Lecturer of Internal Medicine, Ain Shams University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Professor of internal medicine and endocrinology

Role: STUDY_DIRECTOR

Ain Shams University

Assistant Professor of internal medicine and endocrinology

Role: STUDY_DIRECTOR

Ain Shams University

Locations

Ain Shams University Hospitals

Cairo, Abbasya, Egypt

Countries

Egypt

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

FMASU MD 119/2022

Identifier Type: -

Identifier Source: org_study_id