Personalized dietary management for people with type 2 diabetes
Personalized Dietary Management in Type 2 Diabetes
This study is testing whether personalized dietary advice can help people with early-stage type 2 diabetes manage their blood sugar better than standard diets or usual care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 255 (estimated) |
| Ages | 21 Years to 80 Years |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05046886 on ClinicalTrials.gov |
What this trial studies
This clinical trial involves 255 participants with early-stage type 2 diabetes (T2D) who are randomized into three groups: Standardized, Personalized, and Usual Care Control (UCC). The study aims to evaluate the effectiveness of personalized dietary guidance in minimizing postprandial glycemic responses compared to standardized dietary approaches and usual care. Participants will use a smartphone to self-monitor their diet and attend WebEx sessions for support. The trial seeks to address the limitations of one-size-fits-all dietary strategies that have previously shown mixed results in managing glycemic control in T2D patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21-80 diagnosed with early-stage type 2 diabetes and currently managed on a regimen including lifestyle changes and metformin.
Not a fit: Patients with conditions that alter microbiome function or those unable to adhere to dietary self-monitoring may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved glycemic control and reduced vascular complications for patients with type 2 diabetes.
How similar studies have performed: While dietary interventions for T2D have had mixed results, this personalized approach is innovative and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New York, New York
- NYU Langone Health — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Collin J Popp, PhD, RD — NYU Langone Health
- Study coordinator: Margaret Curran
- Email: Margaret.curran@nyulangone.org
- Phone: 646-501-3459
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.