Personalized Dietary Management in Type 2 Diabetes (NCT05046886) | Clinical Trial Compass
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 range21 Years – 80 Years
SexALL
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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…