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Type 2 Diabetes Mellitus (T2DM)NCT07037212

Individualized Medical Nutrition Therapy in Adults With Type 2 Diabetes Mellitus

A study testing Intensive Medical Nutrition Therapy (MNT) and Standard Dietary Counseling in people with Type 2 Diabetes Mellitus (T2DM) and Systemic Inflammation, run by Serap Balaban Barta at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 65 years
What is being tested?
Intensive Medical Nutrition Therapy (MNT) and Standard Dietary Counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Dec 2020to 10 Oct 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Gazi University Medical Hospital

    Ankara

Other trials in Turkey (Türkiye)

About this study

Official 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

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.

Read the detailed description

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.

Being tested
Intensive Medical Nutrition Therapy (MNT), Standard Dietary Counseling
Keywords
Type 2 Diabetes Mellitus, Medical nutrition therapy, Glycemic control, Inflammation, Zonulin
Medical subject headings
Diabetes Mellitus, Type 2, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intensive Medical Nutrition Therapy (MNT)Behavioural

    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 CounselingBehavioural

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

Study groups in NCT07037212
Study groupRoleWhat they receive
Intensive MNT groupExperimentalParticipants 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.
Receives: Behavioral: Intensive Medical Nutrition Therapy (MNT)
Control groupActive comparatorParticipants 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.
Receives: Behavioral: Standard Dietary Counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c (%)

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

    Measured: From enrollment to the end of treatment at 12 weeks

  2. Change in Fasting Plasma Glucose

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

    Measured: From enrollment to the end of treatment at 12 weeks

Secondary outcomes (9)

  1. Change in TNF-α

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

    Measured: From enrollment to the end of treatment at 12 weeks

  2. Change in IL-6

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

    Measured: From enrollment to the end of treatment at 12 weeks

  3. Change in Zonulin

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

    Measured: From enrollment to the end of treatment at 12 weeks

  4. 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.

    Measured: From enrollment to the end of treatment at 12 weeks

  5. 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.

    Measured: From enrollment to the end of treatment at 12 weeks

  6. 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.

    Measured: From enrollment to the end of treatment at 12 weeks

  7. 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.

    Measured: From enrollment to the end of treatment at 12 weeks

  8. 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.

    Measured: From enrollment to the end of treatment at 12 weeks

  9. 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)

    Measured: From enrollment to the end of treatment at 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2025
  2. Study start15 Dec 2020
  3. Primary completion30 Jun 2022
  4. Study completion10 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07037212
Sponsor's protocol ID
2020/095-2020085
Status last verified
Mar 2026
First submitted
8 Jun 2025
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Intensive Medical Nutrition Therapy (MNT) and Standard Dietary Counseling in people with Type 2 Diabetes Mellitus (T2DM) and Systemic Inflammation, run by Serap Balaban Barta at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c (%) (time frame: From enrollment to the end of treatment at 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07037212.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.

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