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

Sponsor
Clinical Nutrition Research Centre, Singapore (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06119035
Collaborator
Singapore Institute for Clinical Sciences (Other)
20
Enrollment
1
Location
1
Arm
8
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Single dose of 75 grams glucose in 200ml water
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
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).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).
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Insulin Modelling Based on Plasma Glucose Measures Via a Minimally-Invasive Glucose Sensor
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
May 31, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: Prediabetes

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

Outcome Measures

Primary Outcome Measures

  1. Glycated Haemoglobin (HbA1c) levels will be analyzed [0 minutes]

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

  2. Insulin levels will be analyzed [4 hours 30 minutes]

    Blood samples will be collected at 17 time points

  3. Glucose levels will be analyzed [4 hours 30 minutes]

    Blood samples will be collected at 17 time points

Secondary Outcome Measures

  1. Serum samples [up to 3 years]

    Serum samples will be frozen for additional future analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Human Development Research Centre, SICS, A*STAR Singapore Singapore 117597

Sponsors and Collaborators

  • Clinical Nutrition Research Centre, Singapore
  • Singapore Institute for Clinical Sciences

Investigators

  • Principal Investigator: James Chan, PhD, Singapore Institute of Food and Biotechnology Innovation (SIFBI), A*STAR

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Chun Yip James Chan, Principal Investigator, Clinical Nutrition Research Centre, Singapore
ClinicalTrials.gov Identifier:
NCT06119035
Other Study ID Numbers:
  • 2023-100
First Posted:
Nov 7, 2023
Last Update Posted:
Nov 8, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Prediabetic State

Study Results

No Results Posted as of Nov 8, 2023