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NCT Number: NCT07037212

Individualized Medical Nutrition Therapy in Adults With Type 2 Diabetes Mellitus

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.

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Key information

Conditions

Type 2 Diabetes Mellitus (T2DM) Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Glycemic Control Inflammation Intestinal Permeability Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammation

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gazi University Medical Hospital

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Standard Dietary Counseling

Behavioral

Participants will receive standard dietary advice in a single counseling session at baseline. No further dietary intervention will be provided.

Primary outcomes

  1. Change in HbA1c (%)

    Time frame: From enrollment to the end of treatment at 12 weeks

    Change in hemoglobin A1c (%) from baseline to 12 weeks.

  2. Change in Fasting Plasma Glucose

    Time frame: From enrollment to the end of treatment at 12 weeks

    Change in fasting glucose levels (mg/dL) from baseline to 12 weeks.

Secondary outcomes

  1. Change in TNF-α

    Time frame: From enrollment to the end of treatment at 12 weeks

    Change in serum tumor necrosis factor-alpha (TNF-α) levels, measured by ELISA, from baseline to 12 weeks.

  2. Change in IL-6

    Time frame: From enrollment to the end of treatment at 12 weeks

    Change in serum interleukin-6 (IL-6) levels, measured by ELISA, from baseline to 12 weeks.

  3. Change in Zonulin

    Time frame: From enrollment to the end of treatment at 12 weeks

    Change in serum zonulin (ZO-1) levels, as a marker of intestinal permeability, measured by ELISA, from baseline to 12 weeks.

  4. Change in Body Weight

    Time frame: From enrollment to the end of treatment at 12 weeks

    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.

  5. Change in Height

    Time frame: From enrollment to the end of treatment at 12 weeks

    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.

  6. Change in Body Mass Index (BMI)

    Time frame: From enrollment to the end of treatment at 12 weeks

    Body weight and height were used to calculate BMI (kg/m²). Change in BMI from baseline to 12 weeks will be reported.

  7. Change in Diabetes-related Quality of Life

    Time frame: From enrollment to the end of treatment at 12 weeks

    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.

  8. Change in Self-Care Behaviors

    Time frame: From enrollment to the end of treatment at 12 weeks

    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.

  9. Change in Physical Activity Score

    Time frame: From enrollment to the end of treatment at 12 weeks

    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)

Sponsors and collaborators

Lead sponsor

Serap Balaban Barta

Other

Registry information

Official study title

The Impact of Individualized Medical Nutrition Therapy on Glycemic Control, Inflammation, and Gut Barrier Regulation in Adults With Type 2 Diabetes Mellitus: a RCT

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 25, 2025
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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