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NCT05046886Completed

Personalized Dietary Management in Type 2 Diabetes

Source: ClinicalTrials.gov · Last updated 18 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
294 (actual)
First submitted
8 Sept 2021
Start date
14 Dec 2021
Primary completion date
22 May 2025
Lead sponsor
NYU Langone Health
NCT number
NCT05046886

What you commit to

  • Study type: Interventional
  • Participants enrolled: 294
  • From 14 Dec 2021 to the primary completion date, 22 May 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 have previously had bariatric surgery, or are unwilling to delay bariatric surgery for the next 7 months

Other illness

  • 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 require special dietary management (end-stage kidney disease, cirrhosis, HIV)
  • those who are unable to participate meaningfully in an intervention that involves self-monitoring using software available in English (e.g., uncorrected sight impairment, illiterate, non-English-speaking, dementia)
  • those who have been diagnosed with a chronic active inflammatory or neoplastic disease in the past 3 years
  • those who have been diagnosed with a chronic gastrointestinal disorder (e.g., inflammatory bowel disease or celiac disease)
  • those who have an active substance use disorder

Lab values

  • those who have a chronic disease that affects energy/glucose metabolism (e.g., Cushing's syndrome, acromegaly, hyperthyroidism)

Other

  • those who are unable or unwilling to adhere to an intervention that requires dietary self-monitoring
  • those who are pregnant, planning to become pregnant during the study period, or become pregnant during the study
  • those who are unable or unwilling to provide informed consent
  • those who are unwilling to accept randomization assignment
  • those who have limited control over diet (e.g., are homeless or institutionalized, in a nursing home or personal care facility, or incarcerated)
  • those who are unable to walk without a walker or cane for 2 city blocks

Who the study is looking for

  • 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

Age in the registry: 21 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
NYU Langone Health
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.