Diabetes MellitusNCT07049601
THE Effect of Tight Glycemic Control on Microvascular Complications in Type 2 Diabetes Mellitus
A study testing Insulin Therapy and Antidiabetic therapy, lifestyle modification in people with Diabetes Mellitus, run by Ain Shams University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Insulin Therapy and Antidiabetic therapy, lifestyle modification
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 11 May 2022to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Tight Glycemic Control on Microvascular Complications in Type 2 Diabetes Mellitus: A Randomized Controlled Trial in an Egyptian Cohort
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.
Read the 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
- Being tested
- Insulin Therapy, Antidiabetic therapy, lifestyle modification
- Keywords
- tight glycemic control
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin TherapyOther
Also called oral antidiabetics, lifestyle and nutrition education
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 modificationOther
Individualized adjustments in antidiabetic therapy, lifestyle modification, and monthly clinical follow-up.
| Study group | Role | What they receive |
|---|---|---|
| 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% Receives: 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 Receives: Other: Insulin Therapy; Other: Antidiabetic therapy, lifestyle modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start11 May 2022
- Primary completion1 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ola Mohamed Moustafa Shaheen, Ain Shams University
- Investigators
- Professor of internal medicine and endocrinology, Study director, Ain Shams UniversityAssistant Professor of internal medicine and endocrinology, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049601
- Sponsor's protocol ID
- FMASU MD 119/2022
- Status last verified
- Jun 2025
- First submitted
- 17 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tight Glycemic Control on Microvascular Complications in Type 2 Diabetes Mellitus: A Randomized Controlled Trial in an Egyptian Cohort
- ClinicalTrials.gov ID
- NCT07049601
- Acronym / sponsor ID
- FMASU MD 119/2022
- Conditions
- Diabetes Mellitus
- Keywords
- tight glycemic control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 11 May 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tight glycemic control | Active comparator | Other: Insulin Therapy, Other: Antidiabetic therapy, lifestyle modificationPatients 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 | Other: Insulin Therapy, Other: Antidiabetic therapy, lifestyle modificationPatients received treatment through insulin therapy, oral hypoglycemics and lifestyle and nutrition education to achieve tight glycemic control with HbA1c less than 7.5 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin TherapyAlso: oral antidiabetics, lifestyle and nutrition educationThe 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 | Less tight glycemic control, Tight glycemic control |
| Antidiabetic therapy, lifestyle modificationIndividualized adjustments in antidiabetic therapy, lifestyle modification, and monthly clinical follow-up. | Other | Less tight glycemic control, Tight glycemic control |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Professor of internal medicine and endocrinology study director
Ain Shams University
Assistant Professor of internal medicine and endocrinology study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insulin Therapy and Antidiabetic therapy, lifestyle modification in people with Diabetes Mellitus, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.