Pre DiabetesAIPSNCT04507685
Asian Indian Prediabetes Study
A study testing Lifestyle (Diet and Exercise) in people with Pre Diabetes, run by Institute for Human Development and Potential (IHDP), Singapore at 1 site in Singapore.
Trial summary
Compared to other races, Indians have higher insulin resistance, poorer pancreatic function and a greater risk of developing diabetes, highlighting the importance of early strategies for improving insulin sensitivity and improving pancreatic function in Indians to prevent diabetes and lower the risk of heart disease. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre Diabetes
- What is being tested?
- Lifestyle (Diet and Exercise)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteSingapore
- Study dates
- 19 Oct 2020to 1 Feb 2023
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female
- Asian Indian ethnicity
- Age between 21-50 years
- BMI not greater than 35 or less than 25
- Prediabetes (based on results from an OGTT conducted in the last 3 months):
- Impaired Fasting Glucose (IFG) which is a fasting blood glucose level of between 5.6 to 6.9 mmol/l and/or
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- Impaired Glucose Tolerance (IGT) which is a blood glucose level of 7.8 to 11.0 mmol/l, 2 hours after the OGTT but below 7.0 mmol/l in the fasting state.
- Not have type 1 or type 2 diabetes
- Not on any diabetes medications that affect insulin sensitivity e.g. metformin, glitazones
- No abnormality of clinical significance on medical history
- If female, not pregnant or breast feeding
- No history of coronary artery disease or cardiac (heart) abnormalities
- Participants must understand the procedures involved and agree to participate in the study by giving full informed, written consent
Who cannot join
- BMI greater than 35 or less than 25
- Weight gain or loss of more than 5% over the past 3 months
- Have anaemia (low haemoglobin/ red blood cell levels), a malignancy (cancer), abnormal liver function, any significant endocrinopathy (e.g. thyroid problems), or a history of metabolic disease such as liver, kidney, cardiovascular, respiratory or gastrointestinal disease.
- Have high uncontrolled hypertension (resting seated blood pressure >160/100 mmHg)
- Taking medications that may affect glucose metabolism e.g. steroids, thiazide diuretics at doses>25mg/day.
- History of smoking or using nicotine products during the 6 months prior to study
Show all 18Show fewer
- History of heavy alcohol consumption (> 5 standard drinks/day)
- Inability to limit alcohol consumption for study duration
- Lactose Intolerant or have a nut allergy
- Have depression
- Have a musculoskeletal injury, joint or peripheral vascular disease sufficient to impede exercise (such as hip arthritis, foot, ankle problems or pain)
- Have severe exercise-induced asthma
- Participating in a regular aerobic or resistance exercise program
- Currently on a weight reducing diet or have an eating disorder
- Contraindications for MRI e.g. if you have certain metallic implants/devices such as heart valves of a cardiac pacemaker which may be affected by the magnetic field
- Unwilling to be randomized to either diet group
- Extended absences due to travel or other commitments
- Unable to comprehend or cope with study requirements
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Singapore Institute for Clinical Sciences (SICS)
Singapore, 117549
About this study
Official title: Diet and Lifestyle Intervention Strategies to Treat β-cell Dysfunction and Insulin Resistance in Asian Indians
Compared to other races, Indians have higher insulin resistance, poorer pancreatic function and a greater risk of developing diabetes, highlighting the importance of early strategies for improving insulin sensitivity and improving pancreatic function in Indians to prevent diabetes and lower the risk of heart disease.
A low carbohydrate diet can deplete fat from undesirable places, such as fat around organs in the abdominal cavity. In this study, we will determine if restriction of dietary carbohydrates will deplete fat in the pancreas and liver, and improve insulin sensitivity and early insulin secretion in Indians. These changes may prevent diabetes from developing. Hepatic and pancreatic fat will be measured using magnetic resonance imaging. Insulin sensitivity and secretion will be measured during an oral glucose tolerance test. In addition, this study will investigate if the higher insulin resistance in Indians is due to genes that cause the inability to store fat in the legs.
The results on the type of diet that is more effective for reducing pancreatic and hepatic fat is important for informing dietary guidelines on the use of low carbohydrate diets for diabetes prevention, particularly in Indians who have a higher risk of developing diabetes.
Read the detailed description
Compared to other races, Indians have a greater risk of developing type 2 diabetes (T2D), increased insulin resistance (IR) and more rapid decline in β-cell function, highlighting the urgency and importance of early intervention strategies for improving insulin sensitivity and preserving/improving β-cell function to prevent T2D and mitigate against the increased vascular disease risk.
Preliminary findings show a reduction in glycemic load selectively depletes visceral and ectopic lipid and improves insulin sensitivity and β-cell function in non-diabetic adults. The proposed research will investigate if the phenotypic features increasing T2D risk in individuals of Indian ancestry (IR and impaired β-cell function) can be favorably modified by a low glycemic (LG) intervention, and if the increased IR is attributable to genetic factors regulating adipocyte differentiation and function.
These research objectives will be achieved through a 24-week randomized controlled trial (RCT) comparing isocaloric LG versus control diets in Indians with prediabetes. Compared to individuals in the control group, those on the LG diet are expected to have greater ectopic (pancreas, liver, visceral and intramyocellular) fat depletion assessed with MRI/MRS, and improvements in first phase insulin secretion and insulin sensitivity assessed with the C-peptide model and oral minimal model, respectively during an OGTT. Reductions in hepatic and pancreatic lipids will be associated with improvements in first-phase β-cell response. Individuals with a greater number of risk alleles from a 53-SNP IR genetic risk score will have lower insulin sensitivity and leg fat, supporting the notion that impaired adipocyte differentiation leading to limited peripheral adipose expansion capacity is an important etiological factor underpinning IR cardiometabolic disease in Indians.
The results will broaden the evidence base for effective prevention strategies in this high risk population by investigating the effect of the proposed diet intervention on underlying physiological and molecular mechanisms implicated in the pathophysiology of T2D in Indians.
- Conditions
- Pre Diabetes
- Being tested
- Lifestyle (Diet and Exercise)
- Keywords
- Asian Indians, Prediabetes, Insulin Resistance, Low glycaemic diet, Ectopic Fat
- Medical subject headings
- Glucose Intolerance, Prediabetic State, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle (Diet and Exercise)Other
The LG diet will comprise 20% carbohydrate, 30% protein, and 50% fat (<10% saturated fat). It will have a low glycaemic load; include plant and animal protein; non-starchy vegetables and salad greens; and some low-sugar fruit. Participants will be encouraged to incorporate a variety of foods rich in monounsaturated and polyunsaturated fats in their diet.
The control diet will comprise 50% carbohydrate, 20% protein and 30% total fat (<10% saturated fat). It will reflect the Health Promotion Board's (HPB) recommendations to reduce dietary fat, emphasize wholegrains and include a variety of fruits and vegetables. In contrast to the LG diet, the control diet will have a higher glycaemic load with a greater proportion of energy derived from unrefined carbohydrate foods.
Concurrent to the dietary intervention and consistent with physical activity guidelines, all participants will undertake a 60-min structured exercise program incorporating aerobic/ resistance exercises 3-4 days/week.
| Study group | Role | What they receive |
|---|---|---|
| Low Glycaemic Diet (LG) | Experimental | Low carbohydrate, low saturated fat diet Receives: Other: Lifestyle (Diet and Exercise) |
| Control Diet | Active comparator | High unrefined carbohydrate, low fat diet Receives: Other: Lifestyle (Diet and Exercise) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in β-cell Function [First-phase β-cell response (PhiD)]
First-phase β-cell response (PhiD) will be calculated from blood glucose and C-peptide data during a 3h 75g oral glucose tolerance test (OGTT) using the C-peptide minimal model.
Measured: Week 0, 8 and 24
Change in Insulinogenic index (ΔC-peptide/∆glucose during the first 30 minutes of the OGTT)
ΔC-peptide/∆glucose during the first 30 minutes of the OGTT will be calculated as an index of early insulin secretion (Insulinogenic index).
Measured: Week 0, 8 and 24
Change in Incremental AUC
Incremental AUC over 180 minutes of the OGTT will be calculated for glucose, insulin, and C-peptide.
Measured: Week 0, 8 and 24
Change in Insulin sensitivity (Oral Minimal model)
Insulin sensitivity will be calculated from blood glucose, insulin and C-peptide during a 3h 75g oral glucose tolerance test (OGTT) using both the oral minimal model
Measured: Week 0, 8 and 24
Change in Matsuda index for whole body insulin sensitivity
Measured: Week 0, 8 and 24
Secondary outcomes (14)
Change in Body fat distribution
Body fat distribution will be imaged and quantified using MRI and MRS. Abdominal fat will be segmented to identify and quantify subcutaneous (deep and superficial) and visceral fat compartments. Lower body gluteal fat compartment will also be imaged and quantified. Fat within liver, pancreas and skeletal muscle fibers will be determined by MRI / MRS.
Measured: Week 0, 8 and 24
Change in Weight (kg)
Measured: Week 0, 8 and 24
Change in Blood Pressure
Measured: Week 0, 8 and 24
Change in Body Composition- Total body fat
Total body fat (kg) will be assessed using DXA
Measured: Week 0, 8 and 24
Change in Body Composition- Total lean mass
Total lean mass (kg) will be assessed using DXA
Measured: Week 0, 8 and 24
Genotyping analyses
Genomic DNA isolated from blood samples will be analysed
Measured: Week 0
Change in Blood Lipids (total cholesterol, HDL-C, TAG, lipoprotein subfractions)
Measured: Week 0, 8 and 24
Change in liver enzymes
Measured: Week 0, 8 and 24
Change in inflammatory markers (e.g. IL-6, TNFα and CRP)
Measured: Week 0, 8 and 24
Change in satiety hormones (e.g. leptin, ghrelin, GIP and GLP-1).
Measured: Week 0, 8 and 24
Lipidomics
Lipidomics evaluation of several lipid classes including sphingolipids (sphingomyelins, ceramides and glycosphingolipids) in plasma
Measured: Week 0, 8 and 24
Change in Plasma phospholipid fatty acid (FA) profile
Measured: Week 0, 8 and 24
Change in Gut microbiota composition
Gut microbiota composition will be assessed by 16S or shotgun metagenomic sequencing
Measured: Week 0, 8 and 24
Change in Faecal characteristics- including short chain fatty acids (SCFAs).
Measured: Week 0, 8 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start19 Oct 2020
- Primary completion27 Jan 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre DiabetesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 24-week parallel arm, randomized controlled trial (RCT)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Human Development and Potential (IHDP), Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National Medical Research Foundation (NMRC) Singapore, Almond Board of California
- Responsible party
- Principal investigator, Jeannie Tay, Institute for Human Development and Potential (IHDP), Singapore
- Investigators
- Jeannie Tay, PhD, Principal investigator, Institute for Human Development and Potential (IHDP), Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04507685
- Sponsor's protocol ID
- 2019-078
- Acronym
- AIPS
- Status last verified
- Nov 2023
- First submitted
- 6 Aug 2020
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet and Lifestyle Intervention Strategies to Treat β-cell Dysfunction and Insulin Resistance in Asian Indians
- ClinicalTrials.gov ID
- NCT04507685
- Acronym / sponsor ID
- AIPS / 2019-078
- Conditions
- Pre Diabetes
- Keywords
- Asian Indians, Prediabetes, Insulin Resistance, Low glycaemic diet, Ectopic Fat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Institute for Human Development and Potential (IHDP), SingaporeUniversity, hospital or other
- Collaborators
- National Medical Research Foundation (NMRC) Singapore, Almond Board of California
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 27 Jan 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 11 Aug 2020 (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.
Compared to other races, Indians have higher insulin resistance, poorer pancreatic function and a greater risk of developing diabetes, highlighting the importance of early strategies for improving insulin sensitivity and improving pancreatic function in Indians to prevent diabetes and lower the risk of heart disease.
A low carbohydrate diet can deplete fat from undesirable places, such as fat around organs in the abdominal cavity. In this study, we will determine if restriction of dietary carbohydrates will deplete fat in the pancreas and liver, and improve insulin sensitivity and early insulin secretion in Indians. These changes may prevent diabetes from developing. Hepatic and pancreatic fat will be measured using magnetic resonance imaging. Insulin sensitivity and secretion will be measured during an oral glucose tolerance test. In addition, this study will investigate if the higher insulin resistance in Indians is due to genes that cause the inability to store fat in the legs.
The results on the type of diet that is more effective for reducing pancreatic and hepatic fat is important for informing dietary guidelines on the use of low carbohydrate diets for diabetes prevention, particularly in Indians who have a higher risk of developing diabetes.
Detailed description
Compared to other races, Indians have a greater risk of developing type 2 diabetes (T2D), increased insulin resistance (IR) and more rapid decline in β-cell function, highlighting the urgency and importance of early intervention strategies for improving insulin sensitivity and preserving/improving β-cell function to prevent T2D and mitigate against the increased vascular disease risk.
Preliminary findings show a reduction in glycemic load selectively depletes visceral and ectopic lipid and improves insulin sensitivity and β-cell function in non-diabetic adults. The proposed research will investigate if the phenotypic features increasing T2D risk in individuals of Indian ancestry (IR and impaired β-cell function) can be favorably modified by a low glycemic (LG) intervention, and if the increased IR is attributable to genetic factors regulating adipocyte differentiation and function.
These research objectives will be achieved through a 24-week randomized controlled trial (RCT) comparing isocaloric LG versus control diets in Indians with prediabetes. Compared to individuals in the control group, those on the LG diet are expected to have greater ectopic (pancreas, liver, visceral and intramyocellular) fat depletion assessed with MRI/MRS, and improvements in first phase insulin secretion and insulin sensitivity assessed with the C-peptide model and oral minimal model, respectively during an OGTT. Reductions in hepatic and pancreatic lipids will be associated with improvements in first-phase β-cell response. Individuals with a greater number of risk alleles from a 53-SNP IR genetic risk score will have lower insulin sensitivity and leg fat, supporting the notion that impaired adipocyte differentiation leading to limited peripheral adipose expansion capacity is an important etiological factor underpinning IR cardiometabolic disease in Indians.
The results will broaden the evidence base for effective prevention strategies in this high risk population by investigating the effect of the proposed diet intervention on underlying physiological and molecular mechanisms implicated in the pathophysiology of T2D in Indians.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 24-week parallel arm, randomized controlled trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| Low Glycaemic Diet (LG) | Experimental | Other: Lifestyle (Diet and Exercise)Low carbohydrate, low saturated fat diet |
| Control Diet | Active comparator | Other: Lifestyle (Diet and Exercise)High unrefined carbohydrate, low fat diet |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Male or female
- Asian Indian ethnicity
- Age between 21-50 years
- BMI not greater than 35 or less than 25
- Prediabetes (based on results from an OGTT conducted in the last 3 months):
Key exclusion criteria (18 listed)
- BMI greater than 35 or less than 25
- Weight gain or loss of more than 5% over the past 3 months
- Have anaemia (low haemoglobin/ red blood cell levels), a malignancy (cancer), abnormal liver function, any significant endocrinopathy (e.g. thyroid problems), or a history of metabolic disease such as liver, kidney, cardiovascular, respiratory or gastrointestinal disease.
- Have high uncontrolled hypertension (resting seated blood pressure >160/100 mmHg)
- Taking medications that may affect glucose metabolism e.g. steroids, thiazide diuretics at doses>25mg/day.
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 |
|---|---|---|
| Lifestyle (Diet and Exercise)The LG diet will comprise 20% carbohydrate, 30% protein, and 50% fat (<10% saturated fat). It will have a low glycaemic load; include plant and animal protein; non-starchy vegetables and salad greens; and some low-sugar fruit. Participants will be encouraged to incorporate a variety of foods rich in monounsaturated and polyunsaturated fats in their diet. The control diet will comprise 50% carbohydrate, 20% protein and 30% total fat (<10% saturated fat). It will reflect the Health Promotion Board's (HPB) recommendations to reduce dietary fat, emphasize wholegrains and include a variety of fruits and vegetables. In contrast to the LG diet, the control diet will have a higher glycaemic load with a greater proportion of energy derived from unrefined carbohydrate foods. Concurrent to the dietary intervention and consistent with physical activity guidelines, all participants will undertake a 60-min structured exercise program incorporating aerobic/ resistance exercises 3-4 days/week. | Other | Control Diet, Low Glycaemic Diet (LG) |
Primary outcome
Change in β-cell Function [First-phase β-cell response (PhiD)]
Time frame: Week 0, 8 and 24
First-phase β-cell response (PhiD) will be calculated from blood glucose and C-peptide data during a 3h 75g oral glucose tolerance test (OGTT) using the C-peptide minimal model.
Change in Insulinogenic index (ΔC-peptide/∆glucose during the first 30 minutes of the OGTT)
Time frame: Week 0, 8 and 24
ΔC-peptide/∆glucose during the first 30 minutes of the OGTT will be calculated as an index of early insulin secretion (Insulinogenic index).
Change in Incremental AUC
Time frame: Week 0, 8 and 24
Incremental AUC over 180 minutes of the OGTT will be calculated for glucose, insulin, and C-peptide.
Change in Insulin sensitivity (Oral Minimal model)
Time frame: Week 0, 8 and 24
Insulin sensitivity will be calculated from blood glucose, insulin and C-peptide during a 3h 75g oral glucose tolerance test (OGTT) using both the oral minimal model
Change in Matsuda index for whole body insulin sensitivity
Time frame: Week 0, 8 and 24
14 secondary outcomes
Change in Body fat distribution
Time frame: Week 0, 8 and 24
Change in Weight (kg)
Time frame: Week 0, 8 and 24
Change in Blood Pressure
Time frame: Week 0, 8 and 24
Change in Body Composition- Total body fat
Time frame: Week 0, 8 and 24
Change in Body Composition- Total lean mass
Time frame: Week 0, 8 and 24
Genotyping analyses
Time frame: Week 0
Change in Blood Lipids (total cholesterol, HDL-C, TAG, lipoprotein subfractions)
Time frame: Week 0, 8 and 24
Change in liver enzymes
Time frame: Week 0, 8 and 24
Change in inflammatory markers (e.g. IL-6, TNFα and CRP)
Time frame: Week 0, 8 and 24
Change in satiety hormones (e.g. leptin, ghrelin, GIP and GLP-1).
Time frame: Week 0, 8 and 24
Lipidomics
Time frame: Week 0, 8 and 24
Change in Plasma phospholipid fatty acid (FA) profile
Time frame: Week 0, 8 and 24
Change in Gut microbiota composition
Time frame: Week 0, 8 and 24
Change in Faecal characteristics- including short chain fatty acids (SCFAs).
Time frame: Week 0, 8 and 24
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 22 Nov 2023.
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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.
Jeannie Tay, PhD principal investigator
Institute for Human Development and Potential (IHDP), Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle (Diet and Exercise) in people with Pre Diabetes, run by Institute for Human Development and Potential (IHDP), Singapore 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 13 inclusion and 18 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 22 Nov 2023. 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?
Change in β-cell Function [First-phase β-cell response (PhiD)] (time frame: Week 0, 8 and 24). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Nov 2023; AzTrials last refreshed its copy on 28 Oct 2026.