Mil Familias Cohort Establishment: a Study to Understand Determinants of Diabetes and Its Complications Among US Latinos

Sansum Diabetes Research Institute405 enrolled

Overview

The Mil Familias Cohort Establishment involves enrolling 1000 Latino families with at least one member in the family having type 2 diabetes, including children and youth, and measuring the 5 determinants of human health: genetics, biology, behavior, psychology, and society/environment.

The vision of Mil Familias is to reduce the burden of cardio-metabolic disease among Latino families in Santa Barbara County and beyond. The aim is to establish an observational cohort of 1,000 Latino families, with at least one family member currently living with diabetes, in order to understand better the impact of the 5 determinants of human health (genetics, biology, behavior, psychology, and society/environment) in this population. Once the 1,000-family cohort is established, evidence-based intervention studies will be developed and implemented based on new knowledge, with collaborators from the healthcare, public policy, academic, pharmaceutical, medical device and technology industries. The strategy involves 4 coordinated and iterative components to achieve its mission: 1. Especialistas: Trusted, bilingual community health workers specially-trained in diabetes education, clinical research methodologies, and care referral. The Especialistas will engage directly with participants to conduct research activities, answer questions, and when necessary, refer participants to appropriate, local community resources. 2. Data: Facilitated by Especialistas, each individual participant will contribute information on up to 100 different variables relating to their genetics, biology, psychology, behavior and society/environment, thus creating a one-of-a-kind database and associated specimen biobank on Latino health and lifestyle ("Living Information Bank"). 3. Interventions: Based on the data, evidence-based, collaborative, culturally-relevant prevention and treatment strategies are planned to develop once the cohort of 1,000 families has been established. 4. Allies: This community-based participatory research study requires engagement from key stakeholders from the Latino community, healthcare sectors, hospitals, payers, businesses, people with diabetes and philanthropists. Organizations and individuals support Mil Familias by contributing their resources, experiences, and skill-sets.

Study Type

OBSERVATIONAL

Enrollment

405

Conditions

Type2 Diabetes Mellitus Cardiovascular Diseases

Eligibility

Sex: ALLMin age: 7 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Males or females ≥ 7 years of age at enrollment. 2. Self-reported Latino heritage. 3. Co-resides with immediate family member (as defined above) OR self with established diagnosis of Type 2 Diabetes for at least one year prior to enrollment date. 4. Signed and dated written informed consent by the date of enrollment. 5. Based on the research staff's judgment, subject or subject's representative must have a good understanding, ability, and willingness to adhere to the protocol, including performance of self-monitored data collection during the wearable device portion. \- Exclusion Criteria: 1. Life expectancy \< 6 months. 2. Any active clinically significant physical or mental disease or disorder, which in the investigator's opinion could interfere with the participation of the trial. 3. Language barriers precluding comprehension of study activities and informed consent. 4. Participation in other trials involving medication or device within 1 month prior to enrollment. 5. Known or suspected abuse of alcohol, narcotics, or illicit drugs. -

Locations (1)

Sansum Diabetes Research Institute

Santa Barbara, California, United States

Outcomes

Primary Outcomes

Success (evaluated by Yes/No format) recruiting and establishing an observational cohort of 1,000 Latino families with at least one family member living with type 2 diabetes by deploying the methods proven feasible by Mil Familias Operational Pilot.

The Mil Familias Cohort Establishment will expand upon the Mil Familias Operational Pilot cohort and infrastructure to collect and store the up to 100 proposed variables across the 5 determinants of human health to support long-term Mil Familias implementation. The variables pertaining to each participant will be collected and stored at the initial visit and then annually for up to 3 years. Socio-demographic characteristics of the cohort will be described at enrollment by type 2 diabetes status, including age, gender, self-identified race/ethnicity, number of people in household, education, insurance, income, occupation, HbA1c, and country of birth.

Time frame: 3 years

Secondary Outcomes

Socio-demographics assessed by questionnaire.

Socio-demographics measured by questionnaire - including age, gender, self-identified race/ethnicity, contact information, number in household, income, education, marital status, occupation, caring for elder, night shifts, insurance status, insurance type and payer, influenza immunization status, immigration status, alcohol \& tobacco use, birth place,and duration of time in the United States (\<5 years, 5-9 years, 10-14 years, 15-19 years, 20-24 years, ≥25 years).

Time frame: Introductory interview/ demographics/ contacts and annually up to 3 years

Number of healthcare visits and the difficulty in traveling to the healthcare provider assessed by questionnaire

Number of visits to a healthcare provider in the last year and difficulty in traveling to a healthcare provider measured by interview questionnaire

Time frame: Introductory interview/ demographics/ contacts and annually up to 3 years

Questions regarding personal opinions regarding the burden of diabetes on Latinos measured by specific questions

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Personal opinion regarding type 2 diabetes burden on Latinos measured by 3 questions - why is diabetes common in Latinos, what can be done to prevent diabetes in Latinos, and what things make it difficult to get help with diabetes when it is needed?

Time frame: Introductory interview/ demographics/ contacts and annually up to 3 years

Total daily tortilla consumption

The number of flour and/or corn tortillas consumed daily for the past 30 days is estimated

Time frame: Introductory interview/ demographics/ contacts and annually up to 3 years

Daily sugary drink consumption

Daily sugary drink consumption is measured by the 2 questions in the Sugar Sweetened Beverages module of the Behavioral Risk Factor Surveillance System Questionnaire from the Centers for Disease Control.

Time frame: Introductory interview/ demographics/ contacts and annually up to 3 years

Number of times per week eating meals prepared away from home

NHANES 2017-2018 question asked - During the past 7 days, how many meals did you get that were prepared away from home in places such as restaurants, fast food places, food stands, grocery stores, or from vending machines?

Time frame: Introductory interview/ demographics/ contacts and annually up to 3 years

Laboratory blood draw for evaluation of C-Peptide related to diabetes

C-Peptide, ng/mL, will measured in a laboratory blood draw sample.

Time frame: Laboratory encounter and annually up to 3 years

Laboratory blood draw for evaluation of C-Reactive protein related to diabetes

C-Reactive protein, mg/L, will measured in a laboratory blood draw sample.

Time frame: Laboratory encounter and annually up to 3 years

Laboratory blood draw for evaluation of Complete Blood Count

Complete Blood Count will measured in a laboratory blood draw sample.

Time frame: Laboratory encounter and annually up to 3 years

Laboratory blood draw for evaluation of Comprehensive Metabolic Panel

Comprehensive Metabolic Panel will measured in a laboratory blood draw sample.

Time frame: Laboratory encounter and annually up to 3 years

Laboratory blood draw for evaluation of Glutamic Acid Decarboxylase (GAD) antibodies related to diabetes

Glutamic Acid Decarboxylase (GAD) antibodies, U/mL, will measured in a laboratory blood draw sample.

Time frame: Laboratory encounter and annually up to 3 years

Laboratory blood draw for evaluation of HbA1c related to diabetes

HbA1c % will measured in a laboratory blood draw sample.

Time frame: Laboratory encounter and annually up to 3 years

Laboratory blood draw for evaluation of Insulin autoantibody related to diabetes

Insulin autoantibody, U/mL, will measured in a laboratory blood draw sample.

Time frame: Laboratory encounter and annually up to 3 years

Laboratory blood draw for evaluation of Islet antigen 2 (IA-2) antibody related to diabetes

Islet antigen 2 (IA-2) antibody, U/mL, will measured in a laboratory blood draw sample.

Time frame: Laboratory encounter and annually up to 3 years

Laboratory blood draw for evaluation of lipids

Lipids will measured in a laboratory blood draw sample.

Time frame: Laboratory encounter and annually up to 3 years

Laboratory blood draw for evaluation of Insulin

Insulin, milliunits/L, will measured in a laboratory blood draw sample.

Time frame: Laboratory encounter and annually up to 3 years

Laboratory blood draw for evaluation of thyroid function

Thyroid function will measured in a laboratory blood draw sample.

Time frame: Laboratory encounter and annually up to 3 years

Microalbumin measured in a urine sample

Urine sample collected for measuring microalbumin mg/L

Time frame: Laboratory encounter and annually up to 3 years

Creatinine measured in a urine sample

Urine sample collected for measuring creatinine

Time frame: Laboratory encounter and annually up to 3 years

Microalbumin/creatinine ratio measured in a urine sample

Urine sample collected for measuring the microalbumin/creatinine ratio

Time frame: Laboratory encounter and annually up to 3 years

Cheek cells and saliva for genomic analysis

Cheek epithelial cells from a swab and saliva samples will be collected for genetic analysis

Time frame: Laboratory encounter and annually up to 3 years

Stool samples for microbiome analysis

Stool/fecal samples will be collected for microbiome analysis

Time frame: Laboratory encounter and annually up to 3 years

Height measured by Physical exam

Height measured in centimeters or inches by physical exam

Time frame: Physical exam encounter and annually up to 3 years

Weight measured by Physical exam

Weight measured in kilograms or pounds by physical exam

Time frame: Physical exam encounter and annually up to 3 years

Waist circumference measured by Physical exam

Waist circumference measured in centimeters or inches by physical exam

Time frame: Physical exam encounter and annually up to 3 years

Blood pressure measured by Physical exam

Blood pressure, systolic and diastolic, measured in mmHg by physical exam

Time frame: Physical exam encounter and annually up to 3 years

Temperature measured by Physical exam

Temperature measured in degrees by physical exam

Time frame: Physical exam encounter and annually up to 3 years

Heart rate measured by Physical exam

Heart rate measured in beats per minute by physical exam

Time frame: Physical exam encounter and annually up to 3 years

Foot examination evaluated by Questions and Physical exam

Foot examination with yes or no questions and by physical exam

Time frame: Physical exam encounter and annually up to 3 years

Neuropathy Questions during Physical exam

Questions about neuropathy

Time frame: Physical exam encounter and annually up to 3 years

Retinopathy questions during Physical exam

Questions about retinopathy

Time frame: Physical exam encounter and annually up to 3 years

Dental exam Questions during Physical exam

Questions about dental exams

Time frame: Physical exam encounter and annually up to 3 years

Eye exam Questions during Physical exam

Questions about eye exams

Time frame: Physical exam encounter and annually up to 3 years

Medical history, family medical history, and medication status and history assessed by interview

Medical history including date of diabetes diagnosis, family medical history, and current medications verified by visual inspection and medication history assessed by interview questionnaire

Time frame: Physical exam encounter and annually up to 3 years

Menopausal status, pregnancy status, and gestational diabetes history for women determined by interview

Menopausal status, pregnancy status (number of live births, number of stillbirths, birthweights of live births, and any diagnosis of type 1 diabetes), and gestational diabetes history for female participants will be determined by interview

Time frame: Physical exam encounter and annually up to 3 years

Determination of diabetes related foot disease

Questionnaire for determination of diabetes related foot disease (Q-DFD)