CompletedNot Applicable

Diabetes Mellitus and microRNA as Risk Factors for Mild Cognitive Impairment: Impact of Life Style Modification

Egypt163 participantsStarted 2016-02

Plain-language summary

This is a 2-step study; 1st step was a cross sectional study carried out on 163 consecutive Type 2 Diabetes Mellitus (T2DM) patients employee attending outpatient clinics of the National Research Center (NRC), Egypt. A face-to-face interview was carried out to collect data about demographic data and medical history. Cognitive function assessment was carried out using Adenbrooke's Cognitive Examination III (ACE III) test and the Trail Making Test (TMT) which consists of two parts (A and B). Quality of life and depression were also assessed using Short Form-36 (SF-36) and Hamilton Depression Rating Scale (HRDS) questionnaires respectively. The second step was an interventional study for health education and life style modification. The main outcome measures were Fasting Blood Glucose (FBG), HbA1c, total blood cholesterol, HDL cholesterol, LDL cholesterol and triglycerides, oxidant and antioxidant (Malondialdehyde (MDA), glutathione peroxidase (GPx), glutathione reductase (GR)) which were assessed at baseline and reassessed after the intervention.

Who can participate

Age range

40 Years – 65 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: T2DM patients attending outpatient clinics of Medical Services Unit of the National Research Center (NRC). Exclusion Criteria: T2DM patients with history of head trauma, stroke, transient ischemic attack, brain tumor, epilepsy, psychiatric disease, cardiac or liver failure and visual or hearing disabilities

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

HbA1c

Timeframe: 6 months

Cognitive function

Timeframe: 6 months

Depression

Timeframe: 6 months

Health related quality of life

Timeframe: 6 months

Trial details

NCT IDNCT04891887

SponsorNational Research Centre, Egypt

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-06

View on ClinicalTrials.gov More Diabetes Mellitus, Type 2 trials

Plain-language summary

Who can participate

Age range

40 Years – 65 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.