Diabetes Mellitus, Type 2NCT06005051
Prediabetes Stratification by Multi-omics Profile After Food Intake
A study testing Dietary intervention in people with Diabetes Mellitus, Type 2 and PreDiabetes, run by Stanford University at 1 site in United States.
Trial summary
1 in 3 adults have prediabetes in the United States, and many of them will eventually develop diabetes, which has significant public health and economic costs. However, type 2 diabetes (T2D) and prediabetes are heterogeneous groups with different pathological mechanisms, dysfunctions in different processes, and varied… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, PreDiabetes
- What is being tested?
- Dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2025to 30 Dec 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be 18 years of age or older;
- Not be pregnant;
- Live close to Stanford Campus
- Be generally healthy (with no apparent symptoms at the time of enrollment)
- Patients with prediabetes or diet-controlled or type 2 diabetes or controlled with metformin, will also be allowed to participate.
- Be willing to provide written informed consent for all study procedures.-
Who cannot join
- Major organ diseases,
- Pregnant or lactating. If a participant will become pregnant while in the study, she will be removed from the study.
- are on diabetogenic medications (with the exclusion of metformin),
- have malabsorptive disorders like celiac sprue or similar
- report heavy alcohol use,
- use of weight loss medications or specific diets,
Show all 10Show fewer
- weight change > 2 kg in the last three weeks,
- history of bariatric surgery
- Any medical condition that our physician believes would interfere with study participation or evaluation of results.
- Mental incapacity and/or cognitive impairment on the part of the patient that would preclude the adequate understanding of, or cooperation with, the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
1 in 3 adults have prediabetes in the United States, and many of them will eventually develop diabetes, which has significant public health and economic costs. However, type 2 diabetes (T2D) and prediabetes are heterogeneous groups with different pathological mechanisms, dysfunctions in different processes, and varied disease trajectories. Patient stratifications into subtypes and personalized nutrition interventions are highly needed but not yet available. Metabolic responses (e.g., glucose excursion) after food intake provide a direct observation of personal metabolic control and its association with T2D.
The investigators hope to learn how prediabetes and type 2 diabetes evolve, and specifically what food or exercise can do to mitigate blood sugar response.
Read the detailed description
Screening: The investigators will check fasting blood sugars, HbA1C to determine status (healthy, prediabetes or diabetes).
Enrolled participants will be provided with a Continuous Glucose Monitor (CGM) to measure blood sugars for 10 days and a Fitbit fitness tracker. They will then follow the instructions for each of the 10 days on the monitors:
Day 0: participants will start using the devices and start recording food intake in a food logging app (Cronometer) Day 1-6: Participants will eat a provided portion of white rice (50g of carbohydrates) within 1.5 hrs of waking up). Day 1,3, 5 consume one of the mitigator foods provided (fat (cream), protein (egg whites), or fiber (powdered pea fiber)). Days 2 and 4 no mitigators will be consumed. Day 6 the investigators will ask participants to exercise before eating the rice. Exercise will be moderate for 20 min with constant heart rate level about (220-age)*0.7. During these 6 days participants will be asked to collect microsamples of blood using the Tasso device on the following time points: right after waking up; right before eating their rice; 30 minutes, 1, 2 and 3 hours after the start of the rice meal; right before going to bed
Days 7-9 no intervention, just continue to use devices and log food intake.
Optional- 5 participants who volunteer to repeat this 10 day cycle 3 times.
Optional metabolic tests:
- Oral Glucose Tolerance Test (OGTT) to measure glucose tolerance and beta cell function: participants will be provided with a 75g glucose solution to drink and collect samples at 10-30min intervals for 180 minutes.
- Undergo an insulin sensitivity test (Steady State Plasma Glucose, SSPG)- glucose, insulin and ocreotide infusions will be provided and blood samples taken at 10-30min intervals for 240 min.
- Undergo an Isoglycemic Intravenous Glucose Infusion test (IIGI) to test for incretin hormone function- a glucose infusion will be given and blood samples collected at 10-30 min intervals for 180 min.
- Conditions
- Diabetes Mellitus, Type 2, PreDiabetes
- Being tested
- Dietary intervention
- Medical subject headings
- Diabetes Mellitus, Type 2, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary interventionOther
Using different combination of foods to see if the glucose response to a load of carbohydrates can be mitigated.
| Study group | Role | What they receive |
|---|---|---|
| mitigator | Experimental | Test different foods to see their mitigating effect on blood sugars after a rice meal. Receives: Other: Dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of blood glucose levels after the different dietary and exercise mitigators
Blood glucose value is derived from continuous glucose monitor (CGM) data, expressed in milligrams/deciliter, and measured for 10 days. Comparisons will be made between different mitigators (food and exercise) before and after consuming a standard rice meal.
Measured: 10 days
Changes in postprandial metabolites response as measured by micro-sampling
Dry blood samples will be collected by micro-sampling frequently before and after the standardized meals at 5 time points. Based on those samples, metabolomics (e.g., short-chain fatty acids, amino acids and other polar and nonpolar metabolites) will be extracted and quantified by liquid chromatography mass spectrometry (LC-MS). Both hydrophilic interaction LC and reverse phase LC will be used. Q Exactive will be used for MS. Tandem MS will be collected for annotation. Relative quantification will be used, where the level of metabolites can be compared between samples. Chemical reference will be used for the absolute quantification of targeted metabolites. Comparisons will be made between different mitigators (food and exercise) before and after consuming a standard rice meal.
Measured: 10 days
Secondary outcomes (3)
Changes in postprandial proteomic responses as measured in micro-sampling by Olink
Dry blood samples will be collected by micro-sampling frequently before and after the standardized meals at 5 time points. Based on those samples, proteomics will be quantified by proximity extension assay for the cardiometabolic panel. 96 proteins will be measured in the unit of normalized protein expression. Comparisons will be made between different mitigators (food and exercise) before and after consuming a standard rice meal.
Measured: 10 days
Changes in personal metabolic states through the day as measured in micro-sampling by targeted and untargeted metabolomics (LC-MS)
Dry blood samples will be collected by micro-sampling after getup, after the standardized meals, and before sleep. Based on those samples, metabolomics (e.g., short-chain fatty acids, amino acids and other polar and nonpolar metabolites) will be extracted and quantified by liquid chromatography mass spectrometry (LC-MS). Both hydrophilic LC and reverse phase LC will be used. Q Exactive will be used for MS. Tandem MS will be collected for annotation. Relative quantification will be used, where the level of metabolites can be compared between samples. Chemical reference will be used for the absolute quantification of targeted metabolites. Comparisons will be made for the different time points during the day.
Measured: 10 days
Changes in personal metabolic states through the day as measured in micro-sampling by Olink proteomics
Dry blood samples will be collected by micro-sampling after getup, after the standardized meals, and before sleep. Based on those samples, proteomics will be quantified by proximity extension assay for the cardiometabolic panel. 96 proteins will be measured in the unit of normalized protein expression. Comparisons will be made for the different time points during the day.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start1 Feb 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2026 (estimated)
Why it stopped: Study design changed and we are submitting a new entry under a different study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will consume the meals using the cgm and fitbit devices and log their meal intake.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yue Wu, Stanford University
- Investigators
- Yue Wu, PhD, Study director, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005051
- Sponsor's protocol ID
- 68475
- Status last verified
- May 2025
- First submitted
- 2 Aug 2023
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediabetes Stratification by Multi-omics Profile After Food Intake
- ClinicalTrials.gov ID
- NCT06005051
- Acronym / sponsor ID
- 68475
- Conditions
- Diabetes Mellitus, Type 2, PreDiabetes
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study design changed and we are submitting a new entry under a different study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 22 Aug 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.
1 in 3 adults have prediabetes in the United States, and many of them will eventually develop diabetes, which has significant public health and economic costs. However, type 2 diabetes (T2D) and prediabetes are heterogeneous groups with different pathological mechanisms, dysfunctions in different processes, and varied disease trajectories. Patient stratifications into subtypes and personalized nutrition interventions are highly needed but not yet available. Metabolic responses (e.g., glucose excursion) after food intake provide a direct observation of personal metabolic control and its association with T2D.
The investigators hope to learn how prediabetes and type 2 diabetes evolve, and specifically what food or exercise can do to mitigate blood sugar response.
Detailed description
Screening: The investigators will check fasting blood sugars, HbA1C to determine status (healthy, prediabetes or diabetes).
Enrolled participants will be provided with a Continuous Glucose Monitor (CGM) to measure blood sugars for 10 days and a Fitbit fitness tracker. They will then follow the instructions for each of the 10 days on the monitors:
Day 0: participants will start using the devices and start recording food intake in a food logging app (Cronometer) Day 1-6: Participants will eat a provided portion of white rice (50g of carbohydrates) within 1.5 hrs of waking up). Day 1,3, 5 consume one of the mitigator foods provided (fat (cream), protein (egg whites), or fiber (powdered pea fiber)). Days 2 and 4 no mitigators will be consumed. Day 6 the investigators will ask participants to exercise before eating the rice. Exercise will be moderate for 20 min with constant heart rate level about (220-age)*0.7. During these 6 days participants will be asked to collect microsamples of blood using the Tasso device on the following time points: right after waking up; right before eating their rice; 30 minutes, 1, 2 and 3 hours after the start of the rice meal; right before going to bed
Days 7-9 no intervention, just continue to use devices and log food intake.
Optional- 5 participants who volunteer to repeat this 10 day cycle 3 times.
Optional metabolic tests:
- Oral Glucose Tolerance Test (OGTT) to measure glucose tolerance and beta cell function: participants will be provided with a 75g glucose solution to drink and collect samples at 10-30min intervals for 180 minutes.
- Undergo an insulin sensitivity test (Steady State Plasma Glucose, SSPG)- glucose, insulin and ocreotide infusions will be provided and blood samples taken at 10-30min intervals for 240 min.
- Undergo an Isoglycemic Intravenous Glucose Infusion test (IIGI) to test for incretin hormone function- a glucose infusion will be given and blood samples collected at 10-30 min intervals for 180 min.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will consume the meals using the cgm and fitbit devices and log their meal intake.
| Arm | Type | Receives |
|---|---|---|
| mitigator | Experimental | Other: Dietary interventionTest different foods to see their mitigating effect on blood sugars after a rice meal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be 18 years of age or older;
- Not be pregnant;
- Live close to Stanford Campus
- Be generally healthy (with no apparent symptoms at the time of enrollment)
- Patients with prediabetes or diet-controlled or type 2 diabetes or controlled with metformin, will also be allowed to participate.
Key exclusion criteria (10 listed)
- Major organ diseases,
- Pregnant or lactating. If a participant will become pregnant while in the study, she will be removed from the study.
- are on diabetogenic medications (with the exclusion of metformin),
- have malabsorptive disorders like celiac sprue or similar
- report heavy alcohol use,
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 |
|---|---|---|
| Dietary interventionUsing different combination of foods to see if the glucose response to a load of carbohydrates can be mitigated. | Other | mitigator |
Primary outcome
Comparison of blood glucose levels after the different dietary and exercise mitigators
Time frame: 10 days
Blood glucose value is derived from continuous glucose monitor (CGM) data, expressed in milligrams/deciliter, and measured for 10 days. Comparisons will be made between different mitigators (food and exercise) before and after consuming a standard rice meal.
Changes in postprandial metabolites response as measured by micro-sampling
Time frame: 10 days
Dry blood samples will be collected by micro-sampling frequently before and after the standardized meals at 5 time points. Based on those samples, metabolomics (e.g., short-chain fatty acids, amino acids and other polar and nonpolar metabolites) will be extracted and quantified by liquid chromatography mass spectrometry (LC-MS). Both hydrophilic interaction LC and reverse phase LC will be used. Q Exactive will be used for MS. Tandem MS will be collected for annotation. Relative quantification will be used, where the level of metabolites can be compared between samples. Chemical reference will be used for the absolute quantification of targeted metabolites. Comparisons will be made between different mitigators (food and exercise) before and after consuming a standard rice meal.
3 secondary outcomes
Changes in postprandial proteomic responses as measured in micro-sampling by Olink
Time frame: 10 days
Changes in personal metabolic states through the day as measured in micro-sampling by targeted and untargeted metabolomics (LC-MS)
Time frame: 10 days
Changes in personal metabolic states through the day as measured in micro-sampling by Olink proteomics
Time frame: 10 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
Yue Wu, PhD study director
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention in people with Diabetes Mellitus, Type 2 and PreDiabetes, run by Stanford University at 1 site in United States.
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 10 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: withdrawn, as of the sponsor's last update on 15 May 2025. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Comparison of blood glucose levels after the different dietary and exercise mitigators (time frame: 10 days). The study lists 2 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 15 May 2025.