ACTIVE_NOT_RECRUITING

Personalized Dietary Management in Type 2 Diabetes

Conditions

Type 2 Diabetes precision nutrition Mediterranean diet behavioral intervention

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Personalized Dietary Management in Type 2 Diabetes

Quick Facts

Study Start:2021-12-14

Study Completion:2025-11-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05046886

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Collin J Popp, PhD, RD

PRINCIPAL_INVESTIGATOR

NYU Langone Health

Study Locations (Sites)

NYU Langone Health

New York, New York, 10016

United States

Collaborators and Investigators

Sponsor: NYU Langone Health

Collin J Popp, PhD, RD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

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

Study Start Date2021-12-14

Study Completion Date2025-11-30

Study Record Updates

Study Start Date2021-12-14

Study Completion Date2025-11-30

Terms related to this study

Keywords Provided by Researchers

precision nutrition
Mediterranean diet
behavioral intervention

Additional Relevant MeSH Terms

Type 2 Diabetes