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

NCT07049601 | Completed DMC

• 1 other identifier: FMASU MD 119/2022
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

tight glycemic control

Outcome Measures

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

  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.

  18 months

Study Arms (2)

Tight glycemic control

ACTIVE COMPARATOR

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

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

Less tight glycemic control

ACTIVE COMPARATOR

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

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

Interventions

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%

Also known as: oral antidiabetics, lifestyle and nutrition education

Less tight glycemic control; Tight glycemic control

Antidiabetic therapy, lifestyle modification OTHER

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

Less tight glycemic control; Tight glycemic control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Abbasya, 123, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Convulsive Therapy; Hypoglycemic Agents; Nutrition Assessment

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Professor of internal medicine and endocrinology

  Ain Shams University

  STUDY DIRECTOR

• Assistant Professor of internal medicine and endocrinology

  Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Internal Medicine, Ain Shams University

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: July 3, 2025
• Study Start: May 11, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 30, 2023
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)