Individualized Medical Nutrition Therapy in Adults With Type 2 Diabetes Mellitus (NCT07037212) | Clinical Trial Compass
CompletedNot Applicable
Individualized Medical Nutrition Therapy in Adults With Type 2 Diabetes Mellitus
Turkey (Türkiye)40 participantsStarted 2020-12-15
Plain-language summary
This study aims to investigate the effects of intensive medical nutrition therapy on blood sugar control, systemic inflammation, and gut barrier function in adults with type 2 diabetes mellitus. In this randomized controlled trial, adults with type 2 diabetes mellitus will be assigned to either an intensive medical nutrition therapy group or a control group. The intensive medical nutrition therapy group will receive individualized nutrition therapy and weekly follow-ups for 12 weeks, while the control group will receive standard dietary counseling. The study will assess changes in glycemic control (HbA1c, fasting plasma glucose), inflammatory markers (TNF-α, IL-6), and intestinal permeability (ZO-1), as well as quality of life and self-care behaviors. The goal is to evaluate whether intensive medical nutrition therapy can improve metabolic outcomes and overall health in adults with type 2 diabetes mellitus.
Who can participate
Age range
20 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:
* Diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least one year
* Age 20 to 65 years
* Body Mass Index (BMI) ≥ 25 kg/m²
* Currently receiving oral anti-diabetic (OAD) medications
* HbA1c ≥ 7%
* Able and willing to provide written informed consent
Exclusion Criteria:
* Receiving insulin therapy
* Presence of uncontrolled comorbid conditions (advanced cardiovascular disease, cerebrovascular disease, severe kidney disease, cancer, or diabetes-related vision impairment)
* Presence of acute infection
* Taking antioxidant vitamins or mineral supplements
* Diagnosed with cognitive impairment or dementia
* Using medical devices such as pacemakers or hearing aids
* Currently participating in another dietary program
* Pregnant or breastfeeding
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
1
Change in HbA1c (%)
Timeframe: From enrollment to the end of treatment at 12 weeks
2
Change in Fasting Plasma Glucose
Timeframe: From enrollment to the end of treatment at 12 weeks