PreDiabetesNCT06119035
Insulin Modelling Based on Plasma Glucose Measures Via a Minimally-Invasive Glucose Sensor
A study testing Single dose of 75 grams glucose in 200ml water in people with PreDiabetes, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
Trial summary
The study aims to evaluate insulin as a potential biomarker for prediabetes in Singapore Chinese subjects. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes
- What is being tested?
- Single dose of 75 grams glucose in 200ml water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSingapore
- Study dates
- 6 Nov 2023to 12 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Human Development Research Centre, SICS, A*STAR
Singapore, 117597
About this study
The study aims to evaluate insulin as a potential biomarker for prediabetes in Singapore Chinese subjects.
Read the 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.
- Conditions
- PreDiabetes
- Being tested
- Single dose of 75 grams glucose in 200ml water
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single dose of 75 grams glucose in 200ml waterOther
Consume single dose of 75 grams glucose in 200ml water
| Study group | Role | What they receive |
|---|---|---|
| Prediabetic | Other | n=10, single dose of 75 grams glucose in 200ml water Receives: Other: Single dose of 75 grams glucose in 200ml water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated Haemoglobin (HbA1c) levels will be analyzed
Blood samples will be collected at 1 time point before intervention administration
Measured: 0 minutes
Insulin levels will be analyzed
Blood samples will be collected at 17 time points
Measured: 4 hours 30 minutes
Glucose levels will be analyzed
Blood samples will be collected at 17 time points
Measured: 4 hours 30 minutes
Secondary outcomes (1)
Serum samples
Serum samples will be frozen for additional future analysis
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start6 Nov 2023
- Primary completion12 Jan 2024
- Study completion12 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- 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).
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore Institute of Food and Biotechnology Innovation
- Sponsor type
- Other government
- Collaborators
- Institute for Human Development and Potential (IHDP), Singapore
- Responsible party
- Principal investigator, Chun Yip James Chan, Singapore Institute of Food and Biotechnology Innovation
- Investigators
- James Chan, PhD, Principal investigator, Singapore Institute of Food and Biotechnology Innovation (SIFBI), A*STAR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119035
- Sponsor's protocol ID
- 2023-100
- Status last verified
- Jan 2024
- First submitted
- 23 Oct 2023
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33557840Wang 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.
PubMed 31779625Tan 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.
PubMed 32184203
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Modelling Based on Plasma Glucose Measures Via a Minimally-Invasive Glucose Sensor
- ClinicalTrials.gov ID
- NCT06119035
- Acronym / sponsor ID
- 2023-100
- Conditions
- PreDiabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Collaborators
- Institute for Human Development and Potential (IHDP), Singapore
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 12 Jan 2024 (actual)
- Study completion
- 12 Jan 2024 (actual)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| Prediabetic | Other | Other: Single dose of 75 grams glucose in 200ml watern=10, single dose of 75 grams glucose in 200ml water |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single dose of 75 grams glucose in 200ml waterConsume single dose of 75 grams glucose in 200ml water | Other | Prediabetic |
Primary outcome
Glycated Haemoglobin (HbA1c) levels will be analyzed
Time frame: 0 minutes
Blood samples will be collected at 1 time point before intervention administration
Insulin levels will be analyzed
Time frame: 4 hours 30 minutes
Blood samples will be collected at 17 time points
Glucose levels will be analyzed
Time frame: 4 hours 30 minutes
Blood samples will be collected at 17 time points
1 secondary outcome
Serum samples
Time frame: up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Background: PubMed 33557840Ow 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.
- Background: PubMed 31779625Wang 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.
- Results publication: PubMed 32184203Tan 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.
- Describes Singapore's War on Diabetes, the Ministry of Health (MOH) is studying measures to better support pre-diabetic persons in managing their condition.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for PreDiabetes
Not yet recruiting
Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
Diabetes Mellitus (Type 2), Prediabetes
Active, not recruiting
The Effect of Exercise and Nicotinamide Riboside Muscle Health and Insulin Resistance in Survivors of Childhood Cancer
Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
Not yet recruiting
Effects of Mango on Insulin Sensitivity in Prediabetes
Pre Diabetes
Not yet recruiting
Different Aerobic-to-Resistance Training Ratios in Adults Aged 50 Years and Older With Prediabetes
Prediabetes
Recruiting
Neuromodulation for Metabolic Dysfunction
Spinal Cord Injuries (SCI), Prediabetes / Type 2 Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Chan, PhD principal investigator
Singapore Institute of Food and Biotechnology Innovation (SIFBI), A*STAR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single dose of 75 grams glucose in 200ml water in people with PreDiabetes, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated Haemoglobin (HbA1c) levels will be analyzed (time frame: 0 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06119035, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024.