Clinical trial NCT06119035: Insulin Modelling Based on Plasma Glucose Measures Via a Minimally-Invasive Glucose Sensor
Official title: Insulin Modelling Based on Plasma Glucose Measures Via a Minimally-Invasive Glucose Sensor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Lead sponsor: Singapore Institute of Food and Biotechnology Innovation
Sponsor class: OTHER_GOV
Collaborators: name: Institute for Human Development and Potential (IHDP), Singapore
First posted: 2023-11-07
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study will be carried out as a single-arm, unblinded, intervention study. The total duration of the study is 4 hours and 30 minutes over one day, excluding screening and enrolment time (up to 1 hour).
Primary purpose: BASIC_SCIENCE

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Glycated Haemoglobin (HbA1c) levels will be analyzed
timeFrame: 0 minutes
measure: Insulin levels will be analyzed
timeFrame: 4 hours 30 minutes
measure: Glucose levels will be analyzed
timeFrame: 4 hours 30 minutes
Secondary outcomes:
measure: Serum samples
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Human Development Research Centre, SICS, A*STAR
Study officials:
affiliation: Singapore Institute of Food and Biotechnology Innovation (SIFBI), A*STAR
name: James Chan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.