Individualized Medical Nutrition Therapy in Adults With Type 2 Diabetes Mellitus

NCT07037212 | Completed

• 1 other identifier: 2020/095-2020085
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes Mellitus (T2DM); Systemic Inflammation; Intestinal Permeability; Glycemic Control

Keywords

Type 2 Diabetes Mellitus; Medical nutrition therapy; Glycemic control; Inflammation; Zonulin

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (9)

• Change in TNF-α

  From enrollment to the end of treatment at 12 weeks

• Change in IL-6

  From enrollment to the end of treatment at 12 weeks

• Change in Zonulin

  From enrollment to the end of treatment at 12 weeks

• Change in Body Weight

  From enrollment to the end of treatment at 12 weeks

• Change in Height

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

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.

Behavioral: Intensive Medical Nutrition Therapy (MNT)

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.

Behavioral: Standard Dietary Counseling

Interventions

Standard Dietary Counseling BEHAVIORAL

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

Control group

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.

Intensive MNT group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Serap Balaban Barta: lead

Study Sites (1)

Gazi University Medical Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Inflammation

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Researcher

Model Details: 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.

Study Record Dates

• First Submitted: June 8, 2025
• First Posted: June 25, 2025
• Study Start: December 15, 2020
• Primary Completion: June 30, 2022
• Study Completion: October 10, 2022
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)