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临床试验/NCT06119035
NCT06119035已完成不适用

Insulin Modelling Based on Plasma Glucose Measures Via a Minimally-Invasive Glucose Sensor

Clinical Nutrition Research Centre, Singapore2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年11月6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
20
试验地点
2
主要终点
Glycated Haemoglobin (HbA1c) levels will be analyzed

研究概览

简要总结

The study aims to evaluate insulin as a potential biomarker for prediabetes in Singapore Chinese subjects.

详细描述

The prevalence of type 2 diabetes (T2DM) in Singapore is expected to increase from 400,000 to 1,000,000 individuals by 2050, resulting in nearly US$2 billion in economic costs. Pre-diabetes is defined as an intermediate state of hyperglycemia where blood glucose levels are elevated but are below the diagnostic levels of diabetes. In Singapore, approximately 1 in 7, or 430,000 residents are estimated to be pre-diabetic, and globally this number is estimated at 7.3% of adults (equivalent to 352.1 million individuals). Up to 70% of pre-diabetics eventually develop overt T2DM; however, pre-diabetes may be reversible with early detection, providing a window for opportune disease interception.

While blood glucose is currently used to detect pre-diabetes, homeostatic mechanisms can maintain normal blood glucose levels and mask the detection of pre-diabetes until overt hyperglycemia is exhibited. In contrast, numerous studies have demonstrated that insulin levels increase markedly in pre-diabetes, even as marginal changes are observed in glucose levels. In this study, the investigator aims to determine if dynamic insulin levels observed during an oral glucose tolerance test are more sensitive than glucose alone in detecting prediabetes in a Singapore Chinese population.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
21 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 21-60
  • Chinese ethnicity
  • Male or female
  • Adequate fluency in the English language to understand the informed consent process, study instructions and study assessments.
  • Sufficient vision and hearing to complete the study procedures
  • Willing and able to participate and to give written informed consent

排除标准

  • Diabetes diagnosis based on HbA1c ≥ 6.5%, and fasting plasma glucose ≥ 7.0 mmol/L
  • Past (<3 months prior to the study) or current major metabolic, endocrine, gastrointestinal or cardiovascular disease
  • Individuals diagnosed with non-alcoholic fatty liver disease
  • Women diagnosed with polycystic ovary syndrome
  • Major surgery in the past 2 months
  • Past (<1 month prior to the study) or current use of prescription, over the counter or traditional medication that may influence metabolic or gastrointestinal functioning
  • Presence or past history of alcohol or drug addiction
  • Pregnant or lactating
  • Alcohol intake >1 units per day
  • Body Mass Index <18.5 kg/m2 or ≥30 kg/m2
  • Member of the research team or their immediate family members

结局指标

主要结局

Glycated Haemoglobin (HbA1c) levels will be analyzed

时间窗: 0 minutes

Blood samples will be collected at 1 time point before intervention administration

Insulin levels will be analyzed

时间窗: 4 hours 30 minutes

Blood samples will be collected at 17 time points

Glucose levels will be analyzed

时间窗: 4 hours 30 minutes

Blood samples will be collected at 17 time points

次要结局

  • Serum samples(up to 3 years)

研究者

发起方
Clinical Nutrition Research Centre, Singapore
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Chun Yip James Chan

Principal Investigator

Clinical Nutrition Research Centre, Singapore

研究点 (2)

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