The Impact of Intensive Medical Nutrition Therapy on Glycemic Control, Inflammation, and Gut Barrier Regulation in Adults With Type 2 Diabetes Mellitus: a RCT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in HbA1c (%)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Intensive Medical Nutrition Therapy (MNT) (Behavioral)
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.
干预措施: Standard Dietary Counseling (Behavioral)
结局指标
主要结局
Change in HbA1c (%)
时间窗: From enrollment to the end of treatment at 12 weeks
Change in hemoglobin A1c (%) from baseline to 12 weeks.
Change in Fasting Plasma Glucose
时间窗: From enrollment to the end of treatment at 12 weeks
Change in fasting glucose levels (mg/dL) from baseline to 12 weeks.
次要结局
- 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)
- Change in Body Mass Index (BMI)(From enrollment to the end of treatment at 12 weeks)
- Change in Diabetes-related Quality of Life(From enrollment to the end of treatment at 12 weeks)
- Change in Self-Care Behaviors(From enrollment to the end of treatment at 12 weeks)
- Change in Physical Activity Score(From enrollment to the end of treatment at 12 weeks)
研究者
Serap Balaban Barta
Dr. Researcher
University of Gaziantep