GeneticsSCRAMBLED EGGSNCT02087826
Study of Clinical Response to Acute Metformin By Leveraging Evaluations During a Mixed Meal Tolerance Test for Exploring Glycemia and GeneticS
A study testing Mixed Meal Tolerance Test and Metformin in people with Genetics and Metabolism, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this research study is to examine whether specific genes (e.g. SLC16A11) affect how human beings respond to food and a medication that is commonly used to treat type 2 diabetes. The food the investigators will be studying is specially prepared to contain protein, carbohydrate, and fat. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Genetics, Metabolism, Type 2 Diabetes
- What is being tested?
- Mixed Meal Tolerance Test and Metformin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,017 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Dec 2026
- Phase
- Interventional
- 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 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult males or non-pregnant females
- Age 18-79
- Able and willing to give consent relevant to genetic investigation
Who cannot join
- Women who are pregnant, nursing, or at risk of becoming pregnant
- Currently taking any medications used for the treatment of diabetes
- History of liver disease and/or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 3 times upper limit of normal (ULN)
- Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease equation
- Currently taking or intending to take during the study duration any medication known to affect glycemic parameters, such as glucocorticoids, growth hormone, or fluoroquinolones
- Contraindications to safe use of metformin, including planned radiologic or angiographic study requiring contrast within one week of the study completion
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- Planned changes to any prescribed medications, specifically diuretics, during study enrollment
- Participation in any other interventional study during the study duration
- Conditions causing intestinal malabsorption, including celiac disease or a history of intestinal or gastric bypass surgery
- Dietary restrictions that would prevent consumption of a MMTT
- Objection or inability to take metformin
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Study of Clinical Response to Acute Metformin By Leveraging Evaluations During a Mixed Meal Tolerance Test for Exploring Glycemia and GeneticS (SCRAMBLED EGGS)
The purpose of this research study is to examine whether specific genes (e.g. SLC16A11) affect how human beings respond to food and a medication that is commonly used to treat type 2 diabetes. The food the investigators will be studying is specially prepared to contain protein, carbohydrate, and fat. The drug the investigators are studying is metformin. The investigators hypothesize that physiological responses to the meal and to the medication will differ between carriers and non-carriers of genes associated with type 2 diabetes.
- Conditions
- Genetics, Metabolism, Type 2 Diabetes
- Being tested
- Mixed Meal Tolerance Test, Metformin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixed Meal Tolerance TestOther
The meal will provide a standard amount of total calories, protein, fat, and carbohydrate to each participant at both study visits. Pre-packaged and prepared food, weighed to the nearest gram, will be used.
MetforminDrug
Also called Glucophage, Glumetza, Glucophage XR, Fortamet
Metformin will be administered during this study. This medication is safely prescribed at a maximum dose of 1000 mg twice daily for the treatment or prevention of type 2 diabetes, as well as for other metabolic conditions. To minimize potential side effects of metformin (e.g., GI upset), participants will take ½ the maximum dose of this medication (500 mg twice daily) and for only 5 days. Participants will be informed of the potential side effects of metformin. They will be asked to contact study staff and discontinue the medication if symptoms are very uncomfortable.
| Study group | Role | What they receive |
|---|---|---|
| Carriers of the SLC16A11 risk allele | Active comparator | Day 1: Mixed Meal Tolerance Test
Day 3-7: 500mg metformin, twice daily
Day 8: Mixed Meal Tolerance Test in presence of Metformin Receives: Other: Mixed Meal Tolerance Test; Drug: Metformin |
| Non-carriers of the SLC16A11 risk allele | Placebo comparator | Day 1: Mixed Meal Tolerance Test
Day 3-7: 500mg metformin, twice daily
Day 8: Mixed Meal Tolerance Test in presence of Metformin Receives: Other: Mixed Meal Tolerance Test; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to the Mixed Meal Tolerance Test
Primary endpoint point: 2 hr glucose after the MMTT
Secondary endpoints: 2 hr insulin after the MMTT, change in glucose, insulin, and amino acid and lipid metabolites from baseline to 60 and 120 minutes after the MMTT; change in GLP-1 concentrations from baseline to 5,10, 15, 30, 60, and 120 minutes after the MMTT; and glucose, insulin, and GLP-1 AUC over 120 minutes
Measured: 2 hours after the meal
Secondary outcomes (1)
Response to Metformin
Primary endpoint: change in fasting glucose from Visit 1 to Visit 2
Secondary endpoints: change in fasting insulin, amino acid and lipid metabolites, GLP-1, and HOMA-IR from Visit 1 to Visit 2
Measured: Day 8 of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GeneticsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,017 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Carlos Slim de la Salud, Broad Institute of MIT and Harvard
- Responsible party
- Principal investigator, Laura Natalie Brenner, Massachusetts General Hospital
- Investigators
- Laura N Brenner, MD, Study director, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087826
- Sponsor's protocol ID
- 2014P000255
- Acronym
- SCRAMBLED EGGS
- Status last verified
- Jan 2026
- First submitted
- 12 Mar 2014
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Clinical Response to Acute Metformin By Leveraging Evaluations During a Mixed Meal Tolerance Test for Exploring Glycemia and GeneticS (SCRAMBLED EGGS)
- ClinicalTrials.gov ID
- NCT02087826
- Acronym / sponsor ID
- SCRAMBLED EGGS / 2014P000255
- Conditions
- Genetics, Metabolism, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,017 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Instituto Carlos Slim de la Salud, Broad Institute of MIT and Harvard
- Study start
- Apr 2014 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 Mar 2014 (estimated)
- 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 purpose of this research study is to examine whether specific genes (e.g. SLC16A11) affect how human beings respond to food and a medication that is commonly used to treat type 2 diabetes. The food the investigators will be studying is specially prepared to contain protein, carbohydrate, and fat. The drug the investigators are studying is metformin. The investigators hypothesize that physiological responses to the meal and to the medication will differ between carriers and non-carriers of genes associated with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carriers of the SLC16A11 risk allele | Active comparator | Other: Mixed Meal Tolerance Test, Drug: MetforminDay 1: Mixed Meal Tolerance Test Day 3-7: 500mg metformin, twice daily Day 8: Mixed Meal Tolerance Test in presence of Metformin |
| Non-carriers of the SLC16A11 risk allele | Placebo comparator | Other: Mixed Meal Tolerance Test, Drug: MetforminDay 1: Mixed Meal Tolerance Test Day 3-7: 500mg metformin, twice daily Day 8: Mixed Meal Tolerance Test in presence of Metformin |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult males or non-pregnant females
- Age 18-79
- Able and willing to give consent relevant to genetic investigation
Key exclusion criteria (11 listed)
- Women who are pregnant, nursing, or at risk of becoming pregnant
- Currently taking any medications used for the treatment of diabetes
- History of liver disease and/or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 3 times upper limit of normal (ULN)
- Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease equation
- Currently taking or intending to take during the study duration any medication known to affect glycemic parameters, such as glucocorticoids, growth hormone, or fluoroquinolones
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 |
|---|---|---|
| Mixed Meal Tolerance TestThe meal will provide a standard amount of total calories, protein, fat, and carbohydrate to each participant at both study visits. Pre-packaged and prepared food, weighed to the nearest gram, will be used. | Other | Carriers of the SLC16A11 risk allele, Non-carriers of the SLC16A11 risk allele |
| MetforminAlso: Glucophage, Glumetza, Glucophage XR, FortametMetformin will be administered during this study. This medication is safely prescribed at a maximum dose of 1000 mg twice daily for the treatment or prevention of type 2 diabetes, as well as for other metabolic conditions. To minimize potential side effects of metformin (e.g., GI upset), participants will take ½ the maximum dose of this medication (500 mg twice daily) and for only 5 days. Participants will be informed of the potential side effects of metformin. They will be asked to contact study staff and discontinue the medication if symptoms are very uncomfortable. | Drug | Carriers of the SLC16A11 risk allele, Non-carriers of the SLC16A11 risk allele |
Primary outcome
Response to the Mixed Meal Tolerance Test
Time frame: 2 hours after the meal
Primary endpoint point: 2 hr glucose after the MMTT Secondary endpoints: 2 hr insulin after the MMTT, change in glucose, insulin, and amino acid and lipid metabolites from baseline to 60 and 120 minutes after the MMTT; change in GLP-1 concentrations from baseline to 5,10, 15, 30, 60, and 120 minutes after the MMTT; and glucose, insulin, and GLP-1 AUC over 120 minutes
1 secondary outcome
Response to Metformin
Time frame: Day 8 of the study
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 15 Jan 2026.
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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.
Laura N Brenner, MD study director
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mixed Meal Tolerance Test and Metformin in people with Genetics and Metabolism, run by Massachusetts General Hospital 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 3 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 15 Jan 2026. 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. Some participants in this study may receive a placebo. 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?
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?
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?
Response to the Mixed Meal Tolerance Test (time frame: 2 hours after the meal). 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 Jan 2026.