CompletedNot Applicable

Personalized Dietary Management in Type 2 Diabetes

United States294 participantsStarted 2021-12-14

Plain-language summary

In a randomized trial of 255 participants with early-stage T2D, participants will be randomized to 1 of 3 groups: Standardized, Personalized, or a Usual Care Control (UCC). In the first phase, participants will be randomized with equal allocation to these 3 groups. In the second phase (current phase), the remaining participants will be randomized with equal allocation to the Standardized and UCC groups.

Who can participate

Age range

21 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * must be an adult 21-80 years of age * must be diagnosed with early-stage T2D defined as HbA1c\<8% and managed for the past 3 months on a diabetes regimen that included lifestyle plus metformin. * those who are willing and able to use a smart phone to self monitor their diet and to attend WebEx sessions Exclusion Criteria: * those who have conditions or treatments likely to alter the underlying function of the microbiome, an insulin response that is driven by factors other than glycemic response to food, conditions/treatments that make it difficult to isolate the true nature of the relationship between randomization assignment and weight loss, characteristics or preferences that would preclude meaningful participation in the study * those who are unable or unwilling to adhere to an intervention that requires dietary self-monitoring * those who have been prescribed: (1) antibiotics or antifungals in the past 3 months, (2) diabetic medications other than metformin, (3) weight loss medications, (4) chronic use of steroids or immunosuppressants, (5) atypical antipsychotics, and (6) chemotherapy. * those who are pregnant, planning to become pregnant during the study period, or become pregnant during the study * those who have a chronic disease that affects energy/glucose metabolism (e.g., Cushing's syndrome, acromegaly, hyperthyroidism) * those who require special dietary management (end-stage kidney disease, cirrhosis, HIV) * those who are unable or unwill…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial focused on something called Mean Amplitude of Glycemic Excursion, or MAGE — can you explain what that measures and whether keeping my blood sugar swings smaller is an important goal for my specific situation?
2Since this study tested personalized dietary management for Type 2 diabetes and has already been completed, are the results published yet, and do you think the dietary approach they studied could be relevant to how we manage my diabetes?
3This trial is listed as Phase NA, which I understand is common for lifestyle or dietary studies rather than drug trials — does that mean there are fewer safety unknowns compared to a medication trial, and how confident are you in the evidence behind personalized diet plans for blood sugar control?
4Before considering any approach like what was tested in this trial, should I try a more standard dietary or medication plan first, and how would we know if personalized dietary management is actually working for me?
5How would a personalized dietary approach to managing my blood sugar fit into my daily life practically — for example, would it require continuous glucose monitoring or significant changes to how I eat, and is that something my care team could realistically support?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean Amplitude of Glycemic Excursion (MAGE)

Timeframe: Month 3

Mean Amplitude of Glycemic Excursion (MAGE)

Timeframe: Month 6

Trial details

NCT IDNCT05046886

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-22

Results submitted2026-05-21

View on ClinicalTrials.gov More Type 2 Diabetes trials