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

PreDiabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06119035
• Other study ID #: 2023-100
• Status: Completed
• Phase: N/A
• Start date: November 6, 2023
• Est. completion date: January 12, 2024

Study information

• Verified date: January 2024
• Source: Clinical Nutrition Research Centre, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 12, 2024
• Est. primary completion date: January 12, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• PreDiabetes
• Prediabetic State

Intervention

Other:
• Single dose of 75 grams glucose in 200ml water
Consume single dose of 75 grams glucose in 200ml water

Locations

Country	Name	City	State
Singapore	Human Development Research Centre, SICS, A*STAR	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Clinical Nutrition Research Centre, Singapore	Singapore Institute for Clinical Sciences

Country where clinical trial is conducted

Singapore, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycated Haemoglobin (HbA1c) levels will be analyzed	Blood samples will be collected at 1 time point before intervention administration	0 minutes
Primary	Insulin levels will be analyzed	Blood samples will be collected at 17 time points	4 hours 30 minutes
Primary	Glucose levels will be analyzed	Blood samples will be collected at 17 time points	4 hours 30 minutes
Secondary	Serum samples	Serum samples will be frozen for additional future analysis	up to 3 years

External 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.