DiabetesNCT03674957
The Manitoba Personalized Lifestyle Research (TMPLR) Study
An observational study of Diabetes and Cardiovascular Diseases, run by University of Manitoba at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 30 to 46 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Cardiovascular Diseases, Chronic Kidney Diseases
- How many people
- 840 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2016to Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 46 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: A sample of 800 Manitobans aged 30-46, stratified by sex, BMI, and geography are being recruited. Participants must have lived in Manitoba for a minimum of 5 years. Women who are pregnant or lactating are not eligible to participate. Additionally, because it is expected that very few of the 800 Manitobans who join TMPLR study from the general public will have reduced kidney function (eGFR <30 ml/min), 40 participants (20 female, 20 male, with no set stratification based on BMI or geography) who have severely reduced kidney function are being recruited from the renal health clinic at Seven Oaks General Hospital (Winnipeg, Manitoba).
Who may be able to join
- Participants must have lived in Manitoba for a minimum of 5 years
Who cannot join
- Women who are pregnant or lactating are not eligible to participate
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Diabetes, Cardiovascular Diseases, Chronic Kidney Diseases
- Medical subject headings
- Diabetes Mellitus, Cardiovascular Diseases, Renal Insufficiency, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent fat mass
Measured using dual-energy X-ray absorptiometry
Measured: Baseline
Percent lean mass
Measured using dual-energy X-ray absorptiometry
Measured: Baseline
Bone mineral density
Measured using dual-energy X-ray absorptiometry, calculated as (mg/cm^2)
Measured: Baseline
Secondary outcomes (51)
(ASA24) dietary assessment tool
(ASA24) dietary assessment tool
Measured: Baseline
Food energy intake
Assessed using dietary history questionnaire
Measured: Baseline
Macronutrient intake
Assessed using dietary history questionnaire
Measured: Baseline
Micronutrient intake
Assessed using dietary history questionnaire
Measured: Baseline
Dietary restraint
Score 0-20 from Three-Factor Eating Questionnaire
Measured: Baseline
Dietary disinhibition
Score 0-16 from Three-Factor Eating Questionnaire
Measured: Baseline
Hunger
Score 0-14 from Three-Factor Eating Questionnaire
Measured: Baseline
Pittsburgh sleep quality index
Pittsburgh sleep quality index
Measured: Baseline
Montreal cognitive assessment questionnaire
Total score of 30; minimum score 0; maximum score of 30
Measured: Baseline
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
Measured: Baseline
Childhood retrospective circumstances questionnaire (adapted from the US Panel Study on Income Dynamics)
Childhood retrospective circumstances questionnaire (adapted from the US Panel Study
Measured: Baseline
Weight
Participants change into lightweight scrub tops and bottoms, with shoes removed, to the nearest 0.1 kg using a digital calibrated floor scale
Measured: Baseline
Height
Measured, without shoes, to the nearest 0.1 cm using a stadiometer
Measured: Baseline
Body mass index (BMI)
Calculated as kg/m^2
Measured: Baseline
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
Measured: Baseline
Hip circumference
Measured in triplicate at the widest portion of the buttocks and hips using a fibreglass tape measure
Measured: Baseline
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
Measured: Baseline
Pulse wave velocity
Measured on the non-dominant arm in a sitting position using a Mobil-O-Graph PWA Monitor on two consecutive days
Measured: Day 1 and Day 2
Augmentation index
Measured on the non-dominant arm in a sitting position using a Mobil-O-Graph PWA Monitor on two consecutive days
Measured: Day 1 and Day 2
Blood total cholesterol
Blood total cholesterol
Measured: Baseline
Blood low-density lipoprotein cholesterol
Blood low-density lipoprotein cholesterol
Measured: Baseline
Blood high-density lipoprotein cholesterol
Blood high-density lipoprotein cholesterol
Measured: Baseline
Blood triglycerides
Blood triglycerides
Measured: Baseline
Blood glucose
Blood glucose
Measured: Baseline
Blood insulin
Blood insulin
Measured: Baseline
Blood urea
Blood urea
Measured: Baseline
Blood creatinine
Blood creatinine
Measured: Baseline
Blood high sensitivity C-reactive protein
Blood high sensitivity C-reactive protein
Measured: Baseline
Blood aspartate aminotransferase
Blood aspartate aminotransferase
Measured: Baseline
Blood alanine aminotransferase
Blood alanine aminotransferase
Measured: Baseline
Blood T regulatory cells
Blood T regulatory cells
Measured: Baseline
Blood leptin
Blood leptin
Measured: Baseline
Blood glucagon
Blood glucagon
Measured: Baseline
Urinary melatonin
Urinary melatonin
Measured: Baseline
Red blood cell fatty acids
Red blood cell fatty acids
Measured: Baseline
Plasma fatty acids
Plasma fatty acids
Measured: Baseline
Blood non-cholesterol sterols
Blood non-cholesterol sterols
Measured: Baseline
Blood vitamin C levels
Blood vitamin C levels
Measured: Baseline
Fractional cholesterol synthesis rate
Fractional cholesterol synthesis rate
Measured: Baseline
Triglyceride synthesis rate
Triglyceride synthesis rate
Measured: Baseline
Gastrointestinal microbiome
Microbiome 16S RNA sequencing
Measured: Baseline
Physical activity level
Assessed using accelerometers over a period of 1 week
Measured: 1 week
Muscle strength
Measured using a hand grip dynamometer
Measured: Baseline
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
Measured: Baseline
Functional walking ability
Assessed using a 5-meter gait speed test
Measured: Baseline
Sleep
Average hours of sleep per night; measured using accelerometers over a period of 1 week
Measured: 1 week
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.
Measured: Baseline
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.
Measured: Baseline
Early life experiences by self report
Assessed using the childhood retrospective circumstances questionnaire (adapted from the US Panel Study on Income Dynamics
Measured: Baseline
Early life experiences by maternal report
Assessed using a mother's questionnaire (adapted from the Nurses' Health Study)
Measured: Baseline
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study startMar 2016
- Primary completionDec 2018
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 840 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Research Manitoba
- Responsible party
- Sponsor
- Investigators
- Peter JH Jones, PhD, Study director, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03674957
- Sponsor's protocol ID
- HS18951(H2015:367)
- Status last verified
- Nov 2018
- First submitted
- 12 Apr 2018
- Last updated
- 22 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mackay D, Mollard RC, Granger M, Bruce S, Blewett H, Carlberg J, Duhamel T, Eck P, Faucher P, Hamm NC, Khafipour E, Lix L, McMillan D, Myrie S, Ravandi A, Tangri N, Azad M, Jones PJ. The Manitoba Personalized Lifestyle Research (TMPLR) study protocol: a multicentre bidirectional observational cohort study with administrative health record linkage investigating the interactions between lifestyle and health in Manitoba, Canada. BMJ Open. 2019 Oct 10;9(10):e023318. doi: 10.1136/bmjopen-2018-023318.
PubMed 31604781
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Manitoba Personalized Lifestyle Research (TMPLR) Study
- ClinicalTrials.gov ID
- NCT03674957
- Acronym / sponsor ID
- HS18951(H2015:367)
- Conditions
- Diabetes, Cardiovascular Diseases, Chronic Kidney Diseases
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 840 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Research Manitoba
- Study start
- Mar 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 18 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 30 to 46 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- A sample of 800 Manitobans aged 30-46, stratified by sex, BMI, and geography are being recruited. Participants must have lived in Manitoba for a minimum of 5 years. Women who are pregnant or lactating are not eligible to participate. Additionally, because it is expected that very few of the 800 Manitobans who join TMPLR study from the general public will have reduced kidney function (eGFR <30 ml/min), 40 participants (20 female, 20 male, with no set stratification based on BMI or geography) who have severely reduced kidney function are being recruited from the renal health clinic at Seven Oaks General Hospital (Winnipeg, Manitoba).
Key inclusion criteria (1 listed)
- Participants must have lived in Manitoba for a minimum of 5 years
Key exclusion criteria (1 listed)
- Women who are pregnant or lactating are not eligible to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percent fat mass
Time frame: Baseline
Measured using dual-energy X-ray absorptiometry
Percent lean mass
Time frame: Baseline
Measured using dual-energy X-ray absorptiometry
Bone mineral density
Time frame: Baseline
Measured using dual-energy X-ray absorptiometry, calculated as (mg/cm^2)
51 secondary outcomes
(ASA24) dietary assessment tool
Time frame: Baseline
Food energy intake
Time frame: Baseline
Macronutrient intake
Time frame: Baseline
Micronutrient intake
Time frame: Baseline
Dietary restraint
Time frame: Baseline
Dietary disinhibition
Time frame: Baseline
Hunger
Time frame: Baseline
Pittsburgh sleep quality index
Time frame: Baseline
Montreal cognitive assessment questionnaire
Time frame: Baseline
Frailty status, as determined by the Modified Fried Criteria
Time frame: Baseline
Childhood retrospective circumstances questionnaire (adapted from the US Panel Study on Income Dynamics)
Time frame: Baseline
Weight
Time frame: Baseline
Height
Time frame: Baseline
Body mass index (BMI)
Time frame: Baseline
Waist circumference
Time frame: Baseline
Hip circumference
Time frame: Baseline
Blood pressure
Time frame: Baseline
Pulse wave velocity
Time frame: Day 1 and Day 2
Augmentation index
Time frame: Day 1 and Day 2
Blood total cholesterol
Time frame: Baseline
Blood low-density lipoprotein cholesterol
Time frame: Baseline
Blood high-density lipoprotein cholesterol
Time frame: Baseline
Blood triglycerides
Time frame: Baseline
Blood glucose
Time frame: Baseline
Blood insulin
Time frame: Baseline
Blood urea
Time frame: Baseline
Blood creatinine
Time frame: Baseline
Blood high sensitivity C-reactive protein
Time frame: Baseline
Blood aspartate aminotransferase
Time frame: Baseline
Blood alanine aminotransferase
Time frame: Baseline
Blood T regulatory cells
Time frame: Baseline
Blood leptin
Time frame: Baseline
Blood glucagon
Time frame: Baseline
Urinary melatonin
Time frame: Baseline
Red blood cell fatty acids
Time frame: Baseline
Plasma fatty acids
Time frame: Baseline
Blood non-cholesterol sterols
Time frame: Baseline
Blood vitamin C levels
Time frame: Baseline
Fractional cholesterol synthesis rate
Time frame: Baseline
Triglyceride synthesis rate
Time frame: Baseline
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Derived from this study: PubMed 31604781Mackay D, Mollard RC, Granger M, Bruce S, Blewett H, Carlberg J, Duhamel T, Eck P, Faucher P, Hamm NC, Khafipour E, Lix L, McMillan D, Myrie S, Ravandi A, Tangri N, Azad M, Jones PJ. The Manitoba Personalized Lifestyle Research (TMPLR) study protocol: a multicentre bidirectional observational cohort study with administrative health record linkage investigating the interactions between lifestyle and health in Manitoba, Canada. BMJ Open. 2019 Oct 10;9(10):e023318. doi: 10.1136/bmjopen-2018-023318.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter JH Jones, PhD study director
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Cardiovascular Diseases, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent fat mass (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03674957, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.