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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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% |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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% |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Professor of internal medicine and endocrinology | Ain Shams University | Study Director |
| Assistant Professor of internal medicine and endocrinology | Ain Shams University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Hospitals | Cairo | Abbasya | 123 | Egypt |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 1, 2022 | Jun 25, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D003295 | Convulsive Therapy |
| D007004 | Hypoglycemic Agents |
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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|
| Antidiabetic therapy, lifestyle modification | Other | Individualized adjustments in antidiabetic therapy, lifestyle modification, and monthly clinical follow-up. |
|
| D020164 | Chemical Actions and Uses |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |