The Manitoba Personalized Lifestyle Research (TMPLR) Study

Diabetes Clinical Trial

Official title:

The Manitoba Personalized Lifestyle Research (TMPLR) Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03674957
• Other study ID #: HS18951(H2015:367)
• Status: Terminated
• Start date: March 2016
• Est. completion date: March 2019

Study information

• Verified date: November 2018
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Lifestyle factors, such as diet, physical activity and sleep, are associated with the development of many chronic diseases. The objective of The Manitoba Personalized Lifestyle Research (TMPLR) study is to understand how these lifestyle factors interact with each other and additional factors, such as an individual's genetics and gut microbiome, to influence health. This is an exploratory cross-sectional observational cohort study of adults, with extensive phenotyping by objective health and lifestyle assessments, and retrospective assessment of early life experiences, with retrospective and prospective utilization of secondary data from administrative health records. A planned non-random convenience sample of 840 Manitobans aged 30-46 recruited from the general population, stratified by sex (equal males and females), body mass index (BMI; 60% of participants with a BMI >25 kg/m2), and geography (25% from rural areas,). These stratifications were selected based on Manitoba demographics. Body composition and bone density will be measured by dual energy x-ray absorptiometry. Blood pressure, pulse wave velocity, and augmentation index will be measured on two consecutive days. Chronic disease risk biomarkers will be measured in blood and urine samples. DNA will be extracted for genetic analysis. A fecal sample will be collected for microbiome analysis.

Description:

Lifestyle factors, such as diet, physical activity and sleep, are associated with the development of many chronic diseases. The objective of The Manitoba Personalized Lifestyle Research (TMPLR) study is to understand how these lifestyle factors interact with each other and additional factors, such as an individual's genetics and gut microbiome, to influence health. This is an exploratory cross-sectional observational cohort study of adults, with extensive phenotyping by objective health and lifestyle assessments, and retrospective assessment of early life experiences, with retrospective and prospective utilization of secondary data from administrative health records. A planned non-random convenience sample of 840 Manitobans aged 30-46 recruited from the general population, stratified by sex (equal males and females), body mass index (BMI; 60% of participants with a BMI >25 kg/m2), and geography (25% from rural areas,). These stratifications were selected based on Manitoba demographics. Lifestyle factors assessed will include dietary pattern, physical activity, cardiovascular fitness and sleep. Additional factors such as medical history, socio-economic status, alcohol and tobacco consumption, cognition, stress and anxiety, and early life experiences will also be documented. A maternal survey will be performed. Body composition and bone density will be measured by dual energy x-ray absorptiometry. Blood pressure, pulse wave velocity, and augmentation index will be measured on two consecutive days. Chronic disease risk biomarkers will be measured in blood and urine samples. DNA will be extracted for genetic analysis. A fecal sample will be collected for microbiome analysis. Participants may provide their Manitoba Personal Health Information Number (PHIN) to link their study data with administrative health records.Lifestyle factors, such as diet, physical activity and sleep, are associated with the development of many chronic diseases. The objective of The Manitoba Personalized Lifestyle Research (TMPLR) study is to understand how these lifestyle factors interact with each other and additional factors, such as an individual's genetics and gut microbiome, to influence health. This is an exploratory cross-sectional observational cohort study of adults, with extensive phenotyping by objective health and lifestyle assessments, and retrospective assessment of early life experiences, with retrospective and prospective utilization of secondary data from administrative health records. A planned non-random convenience sample of 840 Manitobans aged 30-46 recruited from the general population, stratified by sex (equal males and females), body mass index (BMI; 60% of participants with a BMI >25 kg/m2), and geography (25% from rural areas,). These stratifications were selected based on Manitoba demographics. Lifestyle factors assessed will include dietary pattern, physical activity, cardiovascular fitness and sleep. Additional factors such as medical history, socio-economic status, alcohol and tobacco consumption, cognition, stress and anxiety, and early life experiences will also be documented. A maternal survey will be performed. Body composition and bone density will be measured by dual energy x-ray absorptiometry. Blood pressure, pulse wave velocity, and augmentation index will be measured on two consecutive days. Chronic disease risk biomarkers will be measured in blood and urine samples. DNA will be extracted for genetic analysis. A fecal sample will be collected for microbiome analysis. Participants may provide their Manitoba Personal Health Information Number (PHIN) to link their study data with administrative health records.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 840
• Est. completion date: March 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 46 Years

Eligibility

Inclusion Criteria:

• Participants must have lived in Manitoba for a minimum of 5 years

Exclusion Criteria:

• Women who are pregnant or lactating are not eligible to participate

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Chronic Kidney Diseases
• Diabetes
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Canada	University of Manitoba	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	Research Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent fat mass	Measured using dual-energy X-ray absorptiometry	Baseline
Primary	Percent lean mass	Measured using dual-energy X-ray absorptiometry	Baseline
Primary	Bone mineral density	Measured using dual-energy X-ray absorptiometry, calculated as (mg/cm^2)	Baseline
Secondary	(ASA24) dietary assessment tool	(ASA24) dietary assessment tool	Baseline
Secondary	Food energy intake	Assessed using dietary history questionnaire	Baseline
Secondary	Macronutrient intake	Assessed using dietary history questionnaire	Baseline
Secondary	Micronutrient intake	Assessed using dietary history questionnaire	Baseline
Secondary	Dietary restraint	Score 0-20 from Three-Factor Eating Questionnaire	Baseline
Secondary	Dietary disinhibition	Score 0-16 from Three-Factor Eating Questionnaire	Baseline
Secondary	Hunger	Score 0-14 from Three-Factor Eating Questionnaire	Baseline
Secondary	Pittsburgh sleep quality index	Pittsburgh sleep quality index	Baseline
Secondary	Montreal cognitive assessment questionnaire	Total score of 30; minimum score 0; maximum score of 30	Baseline
Secondary	Frailty status, as determined by the Modified Fried Criteria	Patients meeting the criteria for = 3 of the following 7 criteria are deemed frail.; Slowness - After two trials of a 5 m walk, average time>6 s; Weakness - After three grip strength measurements with each hand, maximum value 30 kg if male or 20 kg if female; Weight loss - Self-reported weight loss >4.5 kg (10 lbs) or >5% body weight in past 12 months; Exhaustion - Two-item Center for Epidemiologic Studies Depression (CES-D) scale 1 out of 2; Depression - Five-item Geriatric Depression Scale (5-GDS) 2 out of 5; Low physical activity - Paffenbarger Physical Activity Index <383 kcal per week if male or < 270 kcal per week if female; Cognitive impairment - Montreal Cognitive Assessment (MoCA) score <26 out of 30	Baseline
Secondary	Childhood retrospective circumstances questionnaire (adapted from the US Panel Study on Income Dynamics)	Childhood retrospective circumstances questionnaire (adapted from the US Panel Study	Baseline
Secondary	Weight	Participants change into lightweight scrub tops and bottoms, with shoes removed, to the nearest 0.1 kg using a digital calibrated floor scale	Baseline
Secondary	Height	Measured, without shoes, to the nearest 0.1 cm using a stadiometer	Baseline
Secondary	Body mass index (BMI)	Calculated as kg/m^2	Baseline
Secondary	Waist circumference	Measured in triplicate, to the nearest 0.1 cm at the umbilicus, between the last rib and the iliac crest using a fibreglass tape measure	Baseline
Secondary	Hip circumference	Measured in triplicate at the widest portion of the buttocks and hips using a fibreglass tape measure	Baseline
Secondary	Blood pressure	Systolic and diastolic blood pressures are measured in triplicate, on the non-dominant arm in a sitting position using a validated oscillometric blood pressure monitor	Baseline
Secondary	Pulse wave velocity	Measured on the non-dominant arm in a sitting position using a Mobil-O-Graph PWA Monitor on two consecutive days	Day 1 and Day 2
Secondary	Augmentation index	Measured on the non-dominant arm in a sitting position using a Mobil-O-Graph PWA Monitor on two consecutive days	Day 1 and Day 2
Secondary	Blood total cholesterol	Blood total cholesterol	Baseline
Secondary	Blood low-density lipoprotein cholesterol	Blood low-density lipoprotein cholesterol	Baseline
Secondary	Blood high-density lipoprotein cholesterol	Blood high-density lipoprotein cholesterol	Baseline
Secondary	Blood triglycerides	Blood triglycerides	Baseline
Secondary	Blood glucose	Blood glucose	Baseline
Secondary	Blood insulin	Blood insulin	Baseline
Secondary	Blood urea	Blood urea	Baseline
Secondary	Blood creatinine	Blood creatinine	Baseline
Secondary	Blood high sensitivity C-reactive protein	Blood high sensitivity C-reactive protein	Baseline
Secondary	Blood aspartate aminotransferase	Blood aspartate aminotransferase	Baseline
Secondary	Blood alanine aminotransferase	Blood alanine aminotransferase	Baseline
Secondary	Blood T regulatory cells	Blood T regulatory cells	Baseline
Secondary	Blood leptin	Blood leptin	Baseline
Secondary	Blood glucagon	Blood glucagon	Baseline
Secondary	Urinary melatonin	Urinary melatonin	Baseline
Secondary	Red blood cell fatty acids	Red blood cell fatty acids	Baseline
Secondary	Plasma fatty acids	Plasma fatty acids	Baseline
Secondary	Blood non-cholesterol sterols	Blood non-cholesterol sterols	Baseline
Secondary	Blood vitamin C levels	Blood vitamin C levels	Baseline
Secondary	Fractional cholesterol synthesis rate	Fractional cholesterol synthesis rate	Baseline
Secondary	Triglyceride synthesis rate	Triglyceride synthesis rate	Baseline
Secondary	Gastrointestinal microbiome	Microbiome 16S RNA sequencing	Baseline
Secondary	Physical activity level	Assessed using accelerometers over a period of 1 week	1 week
Secondary	Muscle strength	Measured using a hand grip dynamometer	Baseline
Secondary	Cardiorespiratory fitness	Assessed using a metabolic cart to measure oxygen consumption (VO2; mL O2/kg body weight/minute) during a submaximal YMCA bike protocol performed to 85% of age predicted heart rate max	Baseline
Secondary	Functional walking ability	Assessed using a 5-meter gait speed test	Baseline
Secondary	Sleep	Average hours of sleep per night; measured using accelerometers over a period of 1 week	1 week
Secondary	Identification and characterization of susceptibility genes for negative outcomes of lifestyle factors	This is meant to be achieved through a Genome Wide Association Study (GWAS) of Single Nucleotide Polymorphism (SNPs) associated with the measures of the lifestyle factors assessed in the TMPLR cohort, as listed in "outcome measures".; Whole genome genotyping will be conducted with a state of the art genotyping array.	Baseline
Secondary	Identification and characterization of susceptibility genes for negative outcomes of lifestyle factors.	This is meant to be achieved targeted resequencing of target genes know to effect the metabolic traits assessed. This will aid the detection rare of Single Nucleotide Variations (SNVs) impacting the genes functions. Targeted re-sequencing will be conducted with a state of the art methodology.	Baseline
Secondary	Early life experiences by self report	Assessed using the childhood retrospective circumstances questionnaire (adapted from the US Panel Study on Income Dynamics	Baseline
Secondary	Early life experiences by maternal report	Assessed using a mother's questionnaire (adapted from the Nurses' Health Study)	Baseline
Secondary	Early life health conditions from linked administrative health records, from the Manitoba Population Healthy Research Data Repository	Examples of health records include: prescriptions, physician diagnoses and hospital discharge abstracts	Baseline