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临床试验/NCT06005519
NCT06005519已完成不适用

The Short and Long-term Effects of Low AGE Diet on Individuals With and Without Type 2 Diabetes

Marmara University Pendik Training and Research Hospital2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2018年12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
2
主要终点
Change in body weight in long time period

研究概览

简要总结

The aim of this study was to examine the hypothesis that a diet low in advanced glycation end products (AGE) would provide short and long term improvement in metabolic and inflammatory parameters and serum AGE, Srage, carboxymethyllysine (CML) and methylglyoxal (MG) values in individuals with type 2 diabetes. Specifically, in order to observe the effect of AGE content on the results, diabetic patients who are followed up and who know the principles of low glycaemic index and glycaemic load nutrition suitable for diabetic patients, who do not have additional diseases and who do not smoke were selected.

In recent years, it has been determined that AGE accumulation in the tissue has an effect on the pathophysiology of many diseases such as Alzheimer's disease as well as chronic complications of diabetes. However, the contribution of dietary AGE intake to this pool is controversial. There are studies with conflicting results in the literature on whether a low AGE diet is effective on metabolic and biochemical well-being. In addition, studies investigating the effects of reducing AGE content in the diet of people with no chronic disease are limited.

In this study, the metabolic results of dietary modification in the short term of 2 weeks and in the long term of 3 months are determined. In addition, the results are analysed separately in type 2 diabetic and non-diabetic groups. Thus, the data showing the short and long term metabolic effects of dietary AGE levels for diabetic and non-diabetic patients will contribute to the literature.

详细描述

The study included 30 volunteers with type 2 diabetes and 30 healthy participants. During the initial interviews, participants were provided with training on low AGE (advanced glycation end-products) dietary principles. In the same session, measurements were taken and recorded for height, body weight, blood pressure, waist and hip circumference, and body fat percentage. Fasting blood glucose, HbA1c, c-peptide, C reactive protein (CRP), insulin, blood lipid levels, 1-5 anhydroglucitol (1-5 AG), AGE, Soluble AGE Receptor (sRAGE) , methylglyoxal (MG) and carboxymethyllysine (CML) levels were measured through blood samples.

Participants were asked to maintain a dietary journal and were followed up through weekly online or face-to-face meetings. They were called in for a follow-up examination 2 weeks and 3 months after the initial interview. Anthropometric measurements and blood tests were repeated.

After the completion of a 3-month follow-up for all participants, measurements from both the short and long term resulting from the low AGE diet were analyzed by comparing them to the initial measurements, both for participants with and without diabetes.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • To have the competence to adhere to dietary recommendations

排除标准

  • Being <18 years old or >65 years old
  • Having a history of serious cardiovascular diseases (atrial fibrillation, stroke, ischemic heart disease, peripheral vascular disease, heart failure)
  • Having chronic obstructive pulmonary disease
  • Having kidney or liver failure
  • Having a chronic gastrointestinal disease associated with malabsorption or chronic pancreatitis
  • Having a history of rheumatological disease
  • Having a history of severe acute illness, malignancy, or alcohol abuse in the last 1 month
  • Receiving immunosuppressive treatment

结局指标

主要结局

Change in body weight in long time period

时间窗: 90 days

After a 3-months low AGE diet, change in body weight (kg) in diabetic and nondiabetic groups

change in body mass index in short time period

时间窗: 14 days

After a 2-week low AGE diet,change in body mass index in diabetic and nondiabetic groups

change in body mass index in long time period

时间窗: 90 days

After a 3-months low AGE diet, change in body mass index in diabetic and nondiabetic groups

change in waist circumference in long time period

时间窗: 90 days

After a 3-months low AGE diet, change in waist circumference (cm) in diabetic and nondiabetic groups

Change in serum AGE levels in long time period

时间窗: 90 days

After a 3 months low AGE diet, a change in serum AGE levels in the diabetic and nondiabetic groups

change in body weight in short time period

时间窗: 14 days

After a 2-week low AGE diet,change in body weight (kg) in diabetic and nondiabetic groups

Change in serum AGE levels in short time period

时间窗: 14 days

After a 2-week low AGE diet, a change in serum AGE levels in the diabetic and nondiabetic groups

change in waist circumference in short time period

时间窗: 14 days

After a 2-week low AGE diet, change in waist circumference (cm) in diabetic and nondiabetic groups

change in hip circumference in short time period

时间窗: 14 days

After a 2-week low AGE diet, change in hip circumference (cm) in diabetic and nondiabetic groups

change in hip circumference in long time period

时间窗: 90 days

After a 3-months low AGE diet, change in hip circumference (cm) in diabetic and nondiabetic groups

change in body fat percentage in short time period

时间窗: 14 days

After a 2-week low AGE diet,change in body fat percentage (%) in diabetic and nondiabetic groups

change in body fat percentage in long time period

时间窗: 90 days

After a 3-months low AGE diet,change in body fat percentage (%) in diabetic and nondiabetic groups

次要结局

未报告次要终点

研究者

发起方
Marmara University Pendik Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Buğu Usanma Koban

Asst Prof

Marmara University Pendik Training and Research Hospital

研究点 (2)

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