CompletedNot Applicable

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

Egypt80 participantsStarted 2022-05-11

Plain-language 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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 18 months

Trial details

NCT IDNCT07049601

SponsorAin Shams University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-01

View on ClinicalTrials.gov More Diabetes Mellitus trials