Prediabetes / Type 2 DiabetesPhase 4NCT06682351
Heterogeneity of Diabetes: Integrated Muli-Omics to Identify Physiologic Subphenotypes and Evaluate Targeted Prevention
A Phase 4 study testing Metformin, GLP-1A and MED in people with Prediabetes / Type 2 Diabetes, run by Stanford University at 1 site in United States.
Trial summary
The study team will invite participants with prediabetes or mild diabetes (HbA1c 5.7-7.0) to join a 5-year research study that will define subphenotypes of type 2 diabetes based on underlying physiology (eg insulin resistance, beta-cell dysfunction, incretin defect, liver insulin resistance) and then test the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Prediabetes / Type 2 Diabetes
- What is being tested?
- Metformin, GLP-1A and MED
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2024to Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI ≥23 (≥22 in Asians) kg/m2 but < 45 kg/m2
- HbA1c 5.7-8.0% while not on antihyperglycemic medications
Who cannot join
- Recent (<6mos) CVD event
- active malignancy, kidney/liver disease pregnancy/lactation, chronic inflammatory disease, eating disorder, bariatric surgery
- history of acute pancreatitis
- family or personal history of medullary thyroid cancer
- current use of antihyperglycemic, diabetogenic, or weight loss medications (washout allowed if approved by primary physician)
- heavy alcohol use
Show all 9Show fewer
- hct <30, creatinine > 1.4, ALT> 3x ULN
- physical activity >2 hours/day
- inability to come to Stanford CTRU for metabolic testing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jasmine Yang, BA contact
United States1 site
Stanford University
Stanford, California, 94305
Alina Choi, BS, linachoi@stanford.edu
About this study
The study team will invite participants with prediabetes or mild diabetes (HbA1c 5.7-7.0) to join a 5-year research study that will define subphenotypes of type 2 diabetes based on underlying physiology (eg insulin resistance, beta-cell dysfunction, incretin defect, liver insulin resistance) and then test the hypothesis that response to three first-line treatments will vary according to metabolic subphenotype. Variables of interest include glucose, cardiovascular risk markers, and weight. Treatments include Mediterranean diet, metformin, and a GLP-1 agonist. Participants will go through an initial screening, followed by three treatment periods, each lasting 4 months with 3 month washout in-between treatment periods. This study will help us understand how personalized treatments can help control blood glucose, reduce cardiovascular risk, and manage weight. While there may be minor side effects-like slight discomfort from blood tests, gastrointestinal symptoms from some of the medications, and small radiation exposure from DXA body scans-the treatments offered in this study have all been well studied and are known to lower risk for diabetes and cardiovascular disease
- Conditions
- Prediabetes / Type 2 Diabetes
- Being tested
- Metformin, GLP-1A, MED
- Medical subject headings
- Prediabetic State, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called MET
16 weeks of using metformin: Dosing will initiate at 500mg TID and increased to 1000mg BID after one week.
GLP-1ADrug
Also called Glucagon-like peptide-1 analog
16 weeks using GLP1a: Dosing will be titrated per clinical guidelines and as per FDA approved clinical protocols.
MEDDietary supplement
Also called Mediterranean Diet, energy-restricted Mediterranean diet
16 weeks of following a Mediterranean diet: a mostly plant-based diet that includes vegetables, whole grains, whole fruits, legumes, nuts and seeds, with fish being the primary animal protein, and olive oil the primary fat.
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean Diet/GLP1a/Metformin | Experimental | 1. 16 weeks of following a Mediterranean diet: a mostly plant-based diet that includes vegetables, whole grains, whole fruits, legumes, nuts and seeds, with fish being the primary animal protein, and olive oil the primary fat.
2. 3 months washout
3. 16 weeks using GLP1 agonist: Dosing will be titrated per clinical guidelines and as per FDA approved clinical protocols.
4. 3 months washout
5. 16 weeks of using metformin: Dosing will initiate at 500mg TID and increased to 1000mg BID after one week. Receives: Drug: Metformin; Drug: GLP-1A; Dietary Supplement: MED |
| Metformin/Mediterranean Diet/GLP1a | Experimental | 1. 16 weeks of using metformin: Dosing will initiate at 500mg TID and increased to 1000mg BID after one week.
2. 3 months washout
3. 16 weeks of following a Mediterranean diet: a mostly plant-based diet that includes vegetables, whole grains, whole fruits, legumes, nuts and seeds, with fish being the primary animal protein, and olive oil the primary fat.
4. 3 months washout
5. 16 weeks using GLP1 agonist: Dosing will be titrated per clinical guidelines and as per FDA approved clinical protocols. Receives: Drug: Metformin; Drug: GLP-1A; Dietary Supplement: MED |
| GLP1a/Metformin/Mediterranean Diet | Experimental | 1. 16 weeks using GLP1 agonist: Dosing will be titrated per clinical guidelines and as per FDA approved clinical protocols.
2. 3 months washout
3. 16 weeks of using metformin: Dosing will initiate at 500mg TID and increased to 1000mg BID after one week.
4. 3 months washout
5. 16 weeks of following a Mediterranean diet: a mostly plant-based diet that includes vegetables, whole grains, whole fruits, legumes, nuts and seeds, with fish being the primary animal protein, and olive oil the primary fat. Receives: Drug: Metformin; Drug: GLP-1A; Dietary Supplement: MED |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
The study team will compare the change in HbA1c levels from beginning to end of intervention to compare the efficacy of each treatment.
Measured: At month 0, month 4, month 8, month 11, month 15, month 18
Secondary outcomes (11)
Change in Time in Range (TIR)
Change in Time in Rage (TIR) as measured by continuous glucose monitor (CGM). TIR is defined as a range of 70-140 mg/dL. The study team will calculate the changes from beginning to end or each intervention and compare efficacy of each treatment in TIR.
Measured: At month 0, month 4, month 8, month 11, month 15, month 18
Change in body weight
Compare efficacy of each treatment in change in body weight (kg).
Measured: At month 0, month 4, month 8, month 11, month 15, month 18
Change in Blood Pressure
Compare efficacy of each treatment in change in blood pressure.
Measured: At month 0, month 4, month 8, month 11, month 15, month 18
Change in LDL Cholesterol
Change in LDL cholesterol at the beginning and end of each intervention to compare the efficacy of each treatment.
Measured: At month 0, month 4, month 8, month 11, month 15, month 18
Change in Triglycerides
Change in triglycerides at the beginning and end of each intervention period to compare the efficacy of each treatment.
Measured: At month 0, month 4, month 8, month 11, month 15, month 18
Change in high-sensitivity C-reactive protein (hsCRP)
hsCRP will be measured at the beginning and end of each intervention period to compare the efficacy of each treatment.
Measured: At month 0, month 4, month 8, month 11, month 15, month 18
Change in alanine transaminase (ALT)
ALT will be measured at the beginning and end of each intervention period to compare the efficacy of each treatment.
Measured: At month 0, month 4, month 8, month 11, month 15, month 18
Change in adiponectin
Adiponectin will be measured at the beginning and end of each intervention period to compare the efficacy of each treatment.
Measured: At month 0, month 4, month 8, month 11, month 15, month 18
HOMA-B
Change from baseline in HOMA-B at the beginning and end of each intervention period to compare the efficacy of each treatment.
Measured: At month 0, month 4, month 8, month 11, month 15, month 18
HOMA-IR
Change from baseline in HOMA-IR at the beginning and end of each intervention period to compare the efficacy of each treatment.
Measured: At month 0, month 4, month 8, month 11, month 15, month 18
Change in body fat mass
Body fat mass will be measured by dual-energy x-ray absorptiometry (DXA) scan at the beginning and end of each intervention period to compare the efficacy of each treatment.
Measured: At month 0, month 4, month 8, month 11, month 15, month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study startNov 2024 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prediabetes / Type 2 DiabetesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tracey McLaughlin, Stanford University
- Investigators
- Tracey McLaughlin, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682351
- Sponsor's protocol ID
- 76481
- Status last verified
- Nov 2024
- First submitted
- 7 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heterogeneity of Diabetes: Integrated Muli-Omics to Identify Physiologic Subphenotypes and Evaluate Targeted Prevention
- ClinicalTrials.gov ID
- NCT06682351
- Acronym / sponsor ID
- 76481
- Conditions
- Prediabetes / Type 2 Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 12 Nov 2024 (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 team will invite participants with prediabetes or mild diabetes (HbA1c 5.7-7.0) to join a 5-year research study that will define subphenotypes of type 2 diabetes based on underlying physiology (eg insulin resistance, beta-cell dysfunction, incretin defect, liver insulin resistance) and then test the hypothesis that response to three first-line treatments will vary according to metabolic subphenotype. Variables of interest include glucose, cardiovascular risk markers, and weight. Treatments include Mediterranean diet, metformin, and a GLP-1 agonist. Participants will go through an initial screening, followed by three treatment periods, each lasting 4 months with 3 month washout in-between treatment periods. This study will help us understand how personalized treatments can help control blood glucose, reduce cardiovascular risk, and manage weight. While there may be minor side effects-like slight discomfort from blood tests, gastrointestinal symptoms from some of the medications, and small radiation exposure from DXA body scans-the treatments offered in this study have all been well studied and are known to lower risk for diabetes and cardiovascular disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mediterranean Diet/GLP1a/Metformin | Experimental | Drug: Metformin, Drug: GLP-1A, Dietary Supplement: MED1. 16 weeks of following a Mediterranean diet: a mostly plant-based diet that includes vegetables, whole grains, whole fruits, legumes, nuts and seeds, with fish being the primary animal protein, and olive oil the primary fat. 2. 3 months washout 3. 16 weeks using GLP1 agonist: Dosing will be titrated per clinical guidelines and as per FDA approved clinical protocols. 4. 3 months washout 5. 16 weeks of using metformin: Dosing will initiate at 500mg TID and increased to 1000mg BID after one week. |
| Metformin/Mediterranean Diet/GLP1a | Experimental | Drug: Metformin, Drug: GLP-1A, Dietary Supplement: MED1. 16 weeks of using metformin: Dosing will initiate at 500mg TID and increased to 1000mg BID after one week. 2. 3 months washout 3. 16 weeks of following a Mediterranean diet: a mostly plant-based diet that includes vegetables, whole grains, whole fruits, legumes, nuts and seeds, with fish being the primary animal protein, and olive oil the primary fat. 4. 3 months washout 5. 16 weeks using GLP1 agonist: Dosing will be titrated per clinical guidelines and as per FDA approved clinical protocols. |
| GLP1a/Metformin/Mediterranean Diet | Experimental | Drug: Metformin, Drug: GLP-1A, Dietary Supplement: MED1. 16 weeks using GLP1 agonist: Dosing will be titrated per clinical guidelines and as per FDA approved clinical protocols. 2. 3 months washout 3. 16 weeks of using metformin: Dosing will initiate at 500mg TID and increased to 1000mg BID after one week. 4. 3 months washout 5. 16 weeks of following a Mediterranean diet: a mostly plant-based diet that includes vegetables, whole grains, whole fruits, legumes, nuts and seeds, with fish being the primary animal protein, and olive oil the primary fat. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI ≥23 (≥22 in Asians) kg/m2 but < 45 kg/m2
- HbA1c 5.7-8.0% while not on antihyperglycemic medications
Key exclusion criteria (9 listed)
- Recent (<6mos) CVD event
- active malignancy, kidney/liver disease pregnancy/lactation, chronic inflammatory disease, eating disorder, bariatric surgery
- history of acute pancreatitis
- family or personal history of medullary thyroid cancer
- current use of antihyperglycemic, diabetogenic, or weight loss medications (washout allowed if approved by primary physician)
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 |
|---|---|---|
| MetforminAlso: MET16 weeks of using metformin: Dosing will initiate at 500mg TID and increased to 1000mg BID after one week. | Drug | GLP1a/Metformin/Mediterranean Diet, Mediterranean Diet/GLP1a/Metformin, Metformin/Mediterranean Diet/GLP1a |
| GLP-1AAlso: Glucagon-like peptide-1 analog16 weeks using GLP1a: Dosing will be titrated per clinical guidelines and as per FDA approved clinical protocols. | Drug | GLP1a/Metformin/Mediterranean Diet, Mediterranean Diet/GLP1a/Metformin, Metformin/Mediterranean Diet/GLP1a |
| MEDAlso: Mediterranean Diet, energy-restricted Mediterranean diet16 weeks of following a Mediterranean diet: a mostly plant-based diet that includes vegetables, whole grains, whole fruits, legumes, nuts and seeds, with fish being the primary animal protein, and olive oil the primary fat. | Dietary supplement | GLP1a/Metformin/Mediterranean Diet, Mediterranean Diet/GLP1a/Metformin, Metformin/Mediterranean Diet/GLP1a |
Primary outcome
Change in HbA1c
Time frame: At month 0, month 4, month 8, month 11, month 15, month 18
The study team will compare the change in HbA1c levels from beginning to end of intervention to compare the efficacy of each treatment.
11 secondary outcomes
Change in Time in Range (TIR)
Time frame: At month 0, month 4, month 8, month 11, month 15, month 18
Change in body weight
Time frame: At month 0, month 4, month 8, month 11, month 15, month 18
Change in Blood Pressure
Time frame: At month 0, month 4, month 8, month 11, month 15, month 18
Change in LDL Cholesterol
Time frame: At month 0, month 4, month 8, month 11, month 15, month 18
Change in Triglycerides
Time frame: At month 0, month 4, month 8, month 11, month 15, month 18
Change in high-sensitivity C-reactive protein (hsCRP)
Time frame: At month 0, month 4, month 8, month 11, month 15, month 18
Change in alanine transaminase (ALT)
Time frame: At month 0, month 4, month 8, month 11, month 15, month 18
Change in adiponectin
Time frame: At month 0, month 4, month 8, month 11, month 15, month 18
HOMA-B
Time frame: At month 0, month 4, month 8, month 11, month 15, month 18
HOMA-IR
Time frame: At month 0, month 4, month 8, month 11, month 15, month 18
Change in body fat mass
Time frame: At month 0, month 4, month 8, month 11, month 15, month 18
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Jasmine Yang, BA contact
Tracey McLaughlin, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin, GLP-1A and MED in people with Prediabetes / Type 2 Diabetes, 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 2 inclusion and 9 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: opening soon, as of the sponsor's last update on 12 Nov 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alina Choi, BS (7144884516, linachoi@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (time frame: At month 0, month 4, month 8, month 11, month 15, month 18). 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 12 Nov 2024.