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

Ain Shams University

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Other: Insulin Therapy; Other: Antidiabetic therapy, lifestyle modification

Study type: Interventional

Funder types: Other

Identifiers

NCT07049601

FMASU MD 119/2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Tight glycemic control

Active Comparator group

Description:

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

Treatment:

Other: Antidiabetic therapy, lifestyle modification

Other: Insulin Therapy

Less tight glycemic control

Active Comparator group

Description:

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

Treatment:

Other: Antidiabetic therapy, lifestyle modification

Other: Insulin Therapy