NCT07037212

Individualized Medical Nutrition Therapy in Adults With Type 2 Diabetes Mellitus

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Serap Balaban Barta · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	Standard Dietary Counseling	Participants will receive standard dietary advice in a single counseling session at baseline. No further dietary intervention will be provided.

Timeline

• Start date: 2020-12-15
• Primary completion: 2022-06-30
• Completion: 2022-10-10
• First posted: 2025-06-25
• Last updated: 2026-03-27

Locations

1 site across 1 country: Turkey (Türkiye)