Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Type 2 Diabetes Mellitus is associated with systemic inflammation, insulin resistance, and increased intestinal permeability, all of which contribute to disease progression and complications. Intensive medical nutrition therapy has been proposed as a non-pharmacological strategy to improve glycemic control and reduce inflammation. This randomized controlled trial evaluates the impact of a 12-week intensive medical nutrition therapy program on glycemic control, inflammatory markers, and gut barrier function in adults with type 2 diabetes mellitus. Participants will be randomized into two groups: an intensive MNT group receiving individualized dietary counseling with weekly follow-ups, and a control group receiving standard dietary advice. The study will assess changes in fasting plasma glucose, HbA1c, TNF-α, IL-6, and zonulin (ZO-1) levels, along with quality of life and diabetes self-care behaviors. The findings will provide insights into the potential role of medical nutrition therapy in modulating inflammation-related pathways and improving metabolic outcomes in adults with type 2 diabetes mellitus.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive MNT group | Experimental | Participants in this group will receive individualized intensive medical nutrition therapy (MNT) with weekly in-person follow-ups and dietary counseling for 12 weeks. The MNT is tailored based on patient characteristics and focuses on improving glycemic control, reducing inflammation, and enhancing gut barrier function. |
|
| Control group | Active Comparator | Participants in this group will receive standard dietary advice in a single counseling session at baseline. No further follow-up or dietary intervention will be provided during the study period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive Medical Nutrition Therapy (MNT) | Behavioral | Participants will receive individualized intensive medical nutrition therapy (MNT) with weekly dietary counseling and follow-ups for 12 weeks. The intervention focuses on improving glycemic control, reducing systemic inflammation, and enhancing gut barrier function. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c (%) | Change in hemoglobin A1c (%) from baseline to 12 weeks. | From enrollment to the end of treatment at 12 weeks |
| Change in Fasting Plasma Glucose | Change in fasting glucose levels (mg/dL) from baseline to 12 weeks. | From enrollment to the end of treatment at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in TNF-α | Change in serum tumor necrosis factor-alpha (TNF-α) levels, measured by ELISA, from baseline to 12 weeks. | From enrollment to the end of treatment at 12 weeks |
| Change in IL-6 | Change in serum interleukin-6 (IL-6) levels, measured by ELISA, from baseline to 12 weeks. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gazi University Medical Hospital | Ankara | Turkey (Türkiye) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Participants will be randomized into two parallel groups: an intensive medical nutrition therapy (MNT) group receiving individualized MNT with weekly follow-ups for 12 weeks, and a control group receiving standard dietary advice in a single session. Both groups will be followed concurrently.
Not provided
Not provided
Not provided
|
| Standard Dietary Counseling | Behavioral | Participants will receive standard dietary advice in a single counseling session at baseline. No further dietary intervention will be provided. |
|
| From enrollment to the end of treatment at 12 weeks |
| Change in Zonulin | Change in serum zonulin (ZO-1) levels, as a marker of intestinal permeability, measured by ELISA, from baseline to 12 weeks. | From enrollment to the end of treatment at 12 weeks |
| Change in Body Weight | Change in body weight (in kilograms), measured using a calibrated digital scale. Measurements are taken with participants wearing light clothing and no shoes, under fasting conditions. Body weight will be recorded at baseline and at 12 weeks. Body weight is used as a reference value for BMI. | From enrollment to the end of treatment at 12 weeks |
| Change in Height | Change in participant height (in meters), measured using a stadiometer while participants are barefoot and standing upright in the Frankfurt plane. Height will be recorded at baseline and at 12 weeks. Height is used as a reference value for BMI. | From enrollment to the end of treatment at 12 weeks |
| Change in Body Mass Index (BMI) | Body weight and height were used to calculate BMI (kg/m²). Change in BMI from baseline to 12 weeks will be reported. | From enrollment to the end of treatment at 12 weeks |
| Change in Diabetes-related Quality of Life | Change in total score on the Diabetes Quality of Life (DQOL) questionnaire, which ranges from 0 to 135. Higher scores indicate better quality of life. The DQOL includes 45 items covering treatment satisfaction (15 items), psychological impact of the treatment (19 items), concerns/anxieties about the future course and effects of the disease (4 items), and social and occupational concerns/anxieties (7 items). Scores are calculated at baseline and at 12 weeks. | From enrollment to the end of treatment at 12 weeks |
| Change in Self-Care Behaviors | Change in total score on the Summary of Diabetes Self-Care Activities (SDSCA) measure, which ranges from 0 to 7. Higher scores indicate a higher frequency of self-care behaviors. The SDSCA consists of four subscales- diet (4 items), exercise (2 items), blood glucose monitoring (2 items), and foot care (2 items) with a total of 10 questions. | From enrollment to the end of treatment at 12 weeks |
| Change in Physical Activity Score | Change in total physical activity level, assessed using the International Physical Activity Questionnaire - Short Form (IPAQ-SF). The score is calculated in MET-minutes/week based on participant-reported duration and frequency of walking, moderate, and vigorous physical activities over the past 7 days. Scores typically range from 0 to over 10,000 MET-min/week. Higher scores indicate greater levels of physical activity. Categories: Inactive (<600 MET-min/week) Minimally Active (600-3000 MET-min/week) Active (>3000 MET-min/week) | From enrollment to the end of treatment at 12 weeks |
| D004700 | Endocrine System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |