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New treatment option for Diabetes Mellitus, Type 2
Official title Culturally Adapted Dietary Clinical Trial in PR
ClinicalTrials.gov ID: NCT05962372
What this study is testing
- What it's testing
- This project will determine whether a diet culturally adapted to adults in Puerto Rico can effectively decrease cardiometabolic risk factors. This will help define a culturally-appropriate, feasible, and sustainable diet intervention aimed at reducing cardiovascular, type 2 diabetes, and obesity outcomes.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Age 30-65y old at the time of enrollment
- Non-institutionalized
- Living in PR at the time of recruitment and for at least the previous year and not planning to move from the island within the next 3 years
- Able to answer questions without assistance
- Having a cellphone with the capacity to receive text messages and be willing to receive daily text messages from the study on the designated...
You likely can't join if
- Under 30 or over 65 years of age (on the day of the interview).
- Currently not living in Puerto Rico or not lived on the island for at least 1 year or planning to move within 3 years
- Institutionalized
- Not able to answer questions without assistance
- Not having at least 1 of the five listed metabolic criteria
- Self-reported physician-diagnosed type 1 or type 2 diabetes or use of diabetes medication (including insulin) or diabetes-diagnosis values confirmed...
See the full eligibility criteria
- Age 30-65y old at the time of enrollment
- Non-institutionalized
- Living in PR at the time of recruitment and for at least the previous year and not planning to move from the island within the next 3 years
- Able to answer questions without assistance
- Having a cellphone with the capacity to receive text messages and be willing to receive daily text messages from the study on the designated cellphone number
- Having at least one of the following:
- elevated BMI
- elevated waist circumference
- self-reported physician-diagnosed hypertension or use of hypertension medication or measured high blood pressure at the baseline visit
- self-reported physician-diagnosed pre-diabetes or measured pre-diabetes at the baseline visit
- self-reported physician-diagnosed dyslipidemia or use of lipid-lowering agents or laboratory values confirming dyslipidemia
- Under 30 or over 65 years of age (on the day of the interview).
- Currently not living in Puerto Rico or not lived on the island for at least 1 year or planning to move within 3 years
- Institutionalized
- Not able to answer questions without assistance
- Not having at least 1 of the five listed metabolic criteria
- Self-reported physician-diagnosed type 1 or type 2 diabetes or use of diabetes medication (including insulin) or diabetes-diagnosis values confirmed by laboratory
- Self-reported pregnancy
- Gastrointestinal or chronic condition that would impact eating behaviors or nutritional status
- Intolerance or allergies to legumes (i.e.: beans and nuts), vegetable oils (i.e.: corn, olive, canola), or fresh produce
- Living with another person participating in the study
- Participating in another research study that conflicts with PRECISION
The study team makes the final eligibility decision.
Where it's taking place
- San Juan, Puerto Rico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Juan, Puerto Rico. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.