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

NCT06119035 | Completed

• 1 other identifier: 2023-100
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

PreDiabetes

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Serum samples

  up to 3 years

Study Arms (1)

Prediabetic

OTHER

n=10, single dose of 75 grams glucose in 200ml water

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

Interventions

Single dose of 75 grams glucose in 200ml water OTHER

Consume single dose of 75 grams glucose in 200ml water

Prediabetic

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore Institute of Food and Biotechnology Innovation: lead
• Institute for Human Development and Potential (IHDP), Singapore: collaborator

Study Sites (1)

Human Development Research Centre, SICS, A*STAR

Singapore, 117597, Singapore

Location

Related 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.

  PMID: 33557840 BACKGROUND

• 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.

  PMID: 31779625 BACKGROUND

• 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.

  PMID: 32184203 RESULT

Related 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.

MeSH Terms

Conditions

Prediabetic State

Interventions

Water

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• James Chan, PhD

  Singapore Institute of Food and Biotechnology Innovation (SIFBI), A*STAR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: November 7, 2023
• Study Start: November 6, 2023
• Primary Completion: January 12, 2024
• Study Completion: January 12, 2024
• Last Updated: February 2, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)