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Completed

NCT Number: NCT06119035

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

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

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Key information

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human Development Research Centre, SICS, A*STAR

Singapore, 117597

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Smoking
  • 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

Treatment and study plan

Single dose of 75 grams glucose in 200ml water

Other

Consume single dose of 75 grams glucose in 200ml water

Primary outcomes

  1. Glycated Haemoglobin (HbA1c) levels will be analyzed

    Time frame: 0 minutes

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

  2. Insulin levels will be analyzed

    Time frame: 4 hours 30 minutes

    Blood samples will be collected at 17 time points

  3. Glucose levels will be analyzed

    Time frame: 4 hours 30 minutes

    Blood samples will be collected at 17 time points

Secondary outcomes

  1. Serum samples

    Time frame: up to 3 years

    Serum samples will be frozen for additional future analysis

Sponsors and collaborators

Lead sponsor

Singapore Institute of Food and Biotechnology Innovation

Other Gov

Collaborators

  • Institute for Human Development and Potential (IHDP), Singapore

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 7, 2023
Registry last updated
Feb 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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