Intensive Medical Nutrition Therapy in Adults With Type 2 Diabetes Mellitus

NCT ID: NCT07037212

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-15
• Study Completion Date: 2022-10-10

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intensive MNT group

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.

Group Type: EXPERIMENTAL

Intensive Medical Nutrition Therapy (MNT)

Intervention Type: 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.

Control group

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.

Group Type: ACTIVE_COMPARATOR

Standard Dietary Counseling

Intervention Type: BEHAVIORAL

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

Interventions

Intensive Medical Nutrition Therapy (MNT)

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.

Intervention Type: BEHAVIORAL

Standard Dietary Counseling

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Serap Balaban Barta

OTHER

Sponsor Role: lead

Responsible Party

Serap Balaban Barta

Dr. Researcher

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Gazi University Medical Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2020/095-2020085

Identifier Type: -

Identifier Source: org_study_id