Personalized Dietary Management in Type 2 Diabetes
In a randomized trial of 255 participants with early-stage T2D, participants will be randomized with equal allocation (n=85 each) to 1 of 3 groups: Standardized, Personalized, or a Usual Care Control (UCC).
Conditions:
🦠 Type 2 Diabetes
🗓️ Study Start (Actual) 14 December 2021
🗓️ Primary Completion (Estimated) 30 November 2025
✅ Study Completion (Estimated) 30 November 2025
👥 Enrollment (Estimated) 255
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 New York, New York, United States

📋 Eligibility Criteria

Description

    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 unwilling to provide informed consent
    • * 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 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 have previously had bariatric surgery, or are unwilling to delay bariatric surgery for the next 7 months
    • * those who are unable to walk without a walker or cane for 2 city blocks
    • * 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
Ages Eligible for Study: 21 Years to 80 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 8 September 2021
  • First Submitted that Met QC Criteria 8 September 2021
  • First Posted 16 September 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 10 November 2023
  • Last Update Posted 14 November 2023
  • Last Verified November 2023