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临床试验/NCT07696013
NCT07696013已完成不适用

The Effect of Personalized Nutrition on Changes in Metabolic Parameters in Patients With Type 2 Diabetes Mellitus

DINA KEUMALA SARI1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Metabolic Profile

研究概览

简要总结

Type 2 diabetes mellitus (T2DM) is a multifactorial metabolic disorder commonly accompanied by obesity, hypertension, and suboptimal glycemic control, which together increase cardiovascular risk. Conventional dietary recommendations often apply a uniform approach and may not adequately address interindividual metabolic variability. Personalized nutrition has therefore gained attention as a strategy to optimize metabolic outcomes through individualized dietary interventions. This controlled intervention study evaluated the effect of a personalized nutrition program "my plate" on metabolic parameters in patients with T2DM. Participants were assigned to either an intervention group receiving personalized dietary guidance or a control group receiving standard care. Anthropometric parameters (body weight, body mass index, and waist circumference), fasting plasma glucose, and blood pressure were assessed at baseline and after the intervention

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female participants aged >18 years
  • A confirmed diagnosis of type 2 diabetes mellitus based on the Fasting Blood Glucose more than 126 mg/dL
  • Willingness to participate in dietary counseling sessions and undergo metabolic assessments throughout the study period
  • Provision of written informed consent prior to participation

排除标准

  • Currently following a special or therapeutic diet prescribed by a physician or dietitian
  • Previous receipt of dietary counseling
  • Presence of comorbid conditions known to affect metabolic function, as identified through a standardized screening questionnaire
  • Use of weight-loss medications or metabolically active dietary supplements, as determined by the screening form
  • Pregnancy or lactation, as assessed by medical history and physical examination

结局指标

主要结局

Metabolic Profile

时间窗: Baseline, and 12 weeks

Change in Fasting Plasma Glucose (mg/dL)

次要结局

未报告次要终点

研究者

发起方
DINA KEUMALA SARI
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

DINA KEUMALA SARI

Prof

Universitas Sumatera Utara

研究点 (1)

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