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.

Study Overview

• Status: Completed
• Conditions: PreDiabetes
• Intervention / Treatment: Other: Single dose of 75 grams glucose in 200ml water

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 117597
    • Human Development Research Centre, SICS, A*STAR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Prediabetic; n=10, single dose of 75 grams glucose in 200ml water	Other: Single dose of 75 grams glucose in 200ml water; Consume single dose of 75 grams glucose in 200ml water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycated Haemoglobin (HbA1c) levels will be analyzed	Blood samples will be collected at 1 time point before intervention administration	0 minutes
Insulin levels will be analyzed	Blood samples will be collected at 17 time points	4 hours 30 minutes
Glucose levels will be analyzed	Blood samples will be collected at 17 time points	4 hours 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum samples	Serum samples will be frozen for additional future analysis	up to 3 years

Collaborators and Investigators

• Sponsor: Clinical Nutrition Research Centre, Singapore
• Collaborators: Singapore Institute for Clinical Sciences
• Investigators: Principal Investigator: James Chan, PhD, Singapore Institute of Food and Biotechnology Innovation (SIFBI), A*STAR

Publications and helpful links

General Publications

• Ow Yong LM, Koe LWP. War on Diabetes in Singapore: a policy analysis. Health Res Policy Syst. 2021 Feb 8;19(1):15. doi: 10.1186/s12961-021-00678-1.
• Wang Q, Jokelainen J, Auvinen J, Puukka K, Keinanen-Kiukaanniemi S, Jarvelin MR, Kettunen J, Makinen VP, Ala-Korpela M. Insulin resistance and systemic metabolic changes in oral glucose tolerance test in 5340 individuals: an interventional study. BMC Med. 2019 Nov 29;17(1):217. doi: 10.1186/s12916-019-1440-4.
• Tan KW, Dickens BSL, Cook AR. Projected burden of type 2 diabetes mellitus-related complications in Singapore until 2050: a Bayesian evidence synthesis. BMJ Open Diabetes Res Care. 2020 Mar;8(1):e000928. doi: 10.1136/bmjdrc-2019-000928.

Helpful Links

• Describes Singapore's War on Diabetes, the Ministry of Health (MOH) is studying measures to better support pre-diabetic persons in managing their condition.

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2023
• Primary Completion (Actual): January 12, 2024
• Study Completion (Actual): January 12, 2024

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: October 31, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): February 2, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: 2023-100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No