Metabolic SyndromeCHANGENCT01616563
Canadian Health Advanced By Nutrition and Graded Exercise
A study testing Dietary Intervention and Exercise Prescription and Fitness Program in people with Metabolic Syndrome, run by Daren K. Heyland at 3 sites in Canada.
Trial summary
The overall objective of the CHANGE initiative is to change the delivery of care in primary care clinics to treat disease by reducing reliance on drugs and hospitals through the promotion of scientifically validated nutritional concepts and exercise. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Dietary Intervention and Exercise Prescription and Fitness Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 305 participants
- Where
- 3 sitesCanada
- Study dates
- Oct 2012to Feb 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >/= 18 years old
- Fasting Blood Glucose >/= 5.6 mmol/L or receiving pharmacotherapy
- Blood Pressure of >/= 130/85 mm Hg or receiving pharmacotherapy
- Triglyceride of >/= 1.7 mmol/L or receiving pharmacotherapy
- HDL-C < 1.0 mmol/L Males and < 1.3 mmol/L females
- Abdominal circumference as determined by a pre-specified technique:
Show all 9Show fewer
- Europids/Whites/sub-Saharan Africans/Mediterranean/middle east >/= 94 cm Males, >/= 80 cm Female.
- Asian and South Central Americans >/= 90 cm males and >/=80 cm females
- US and Canadian Whites >/= 102 cm males, >/=88 cm females.
Who cannot join
- Inability to speak, read or understand English and/or French for the Laval University participants.
- Having a medical or physical condition that makes moderate intensity physical activity difficult or unsafe.
- Diagnosis of Type 1 Diabetes Mellitus
- Type 2 diabetes mellitus only if any one of the following are present
- Proliferative diabetic retinopathy
- Nephropathy (Suggested parameters: serum creatinine > 160 µmol/L)
Show all 18Show fewer
- Clinically manifest neuropathy defined as absent ankle jerks
- Severe fasting hyperglycemia > 11 mmol/L
- Peripheral vascular disease
- Significant medical co-morbidities, including uncontrolled metabolic disorders (e.g., thyroid, renal , liver), heart disease, stroke and ongoing substance abuse
- Clinically significant renal failure
- Diagnosis of psychiatric disorders (cognitive impairment) that would limit adequate informed consent or ability to comply with study protocol
- Diagnosis of cancer (other than non-melanoma skin cancer) that was active or treated with radiation or chemotherapy within the past 2 years
- Diagnosis of a terminal illness and/or in hospice care
- Pregnant, lactating or planning to become pregnant during the study period
- Investigator discretion for clinical safety or protocol adherence reasons
- Chronic inflammatory diseases
- Body Mass Index > 35
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Edmonton Oliver Primary Care Network
Edmonton, Alberta
Clinique de kinésiologie de l'Université Laval
Québec, G1K 7P4
Canadian Phase Onward Inc.
Toronto, Ontario, M3H 5S4
About this study
Official title: Canadian Health Advanced By Nutrition and Graded Exercise: CHANGE Health Paradigm
The overall objective of the CHANGE initiative is to change the delivery of care in primary care clinics to treat disease by reducing reliance on drugs and hospitals through the promotion of scientifically validated nutritional concepts and exercise. Specifically, the objective is to identify patients from primary care clinics with metabolic syndrome who are not morbidly obese and use diet and exercise interventions to reverse the changes, reduce reliance on pharmacotherapy and prevent progression to diabetes and cardiovascular disease.
Read the detailed description
Hypertension, cardiovascular disease, strokes, diabetes and their complications including renal failure and neuropathy are major contributors to healthcare costs1. Metabolic Syndrome, a widespread genetic trait refers to a group of factors that increase risk for these diseases. Progression of the components of the metabolic syndrome can be significantly reduced by dietary manipulation and exercise.
The aging population, with both metabolic syndrome and muscular weakness, is going to result in an enormous social and financial burden not only for medical care but also for families caring for such patients. Existing knowledge would suggest that dietary modification and exercise training would substantially reduce the costs and complications of these medical conditions.
The Canadian Guidelines for the diagnosis and management of cardiometabolic risk identify patients with metabolic syndrome who have an increased risk of cardiac and vascular disease and diabetes but the application of these results to prevent disease has been a dismal failure in general and in particular, in our country.
The current model of advice about preventive care is through family doctors (FD) in the primary care setting. FDs tend not to advise their patients about diet and exercise for a variety of reasons including a lack of education about these modalities, a lack of support from professionals qualified to assess and advise about diet and exercise, the belief that drugs are better, lack of time and a lack of reimbursement in addition to patient barriers to adoption. Although other factors, such has smoking, hypercoagulability and increased expression of proinflammatory cytokines increase cardiometabolic risk, these changes are closely related to the metabolic syndrome. "Health behavior interventions" are identified as critical to preventing the occurrence of cardiovascular disease and diabetes. These interventions can be associated with appropriate pharmacotherapy where required. The guidelines recommend a multidisciplinary team to manage these interventions. In addition it is also recommended that ethnicity be considered in these interventions.
The various traits associated with the metabolic syndrome are strongly influenced by genetic factors, i.e. the heritability of abdominal obesity and insulin resistance are estimated to be as high as 70%. Accordingly, the investigators propose to examine numerous genetic polymorphisms (also referred to as markers) that have been linked to the various traits associated with metabolic syndrome in a sub study. It is hypothesized that these markers can be used as a means to better predict the variable responses observed in individuals following a lifestyle intervention. Several companies have begun to commercialize direct-to-consumer genetic-testing to provide nutritional counseling to individuals based on the analysis of a small subset of polymorphisms11; however, there is an absence of scientific research to either support or refute the value of genetic markers for predicting an individual's response. Considering common genetic markers in a lifestyle intervention study will enable us to assess their value for predicting response.
- Conditions
- Metabolic Syndrome
- Being tested
- Dietary Intervention, Exercise Prescription and Fitness Program
- Keywords
- central obesity, abdominal obesity, hypertension, cardiovascular disease, high cholesterol, high triglycerides, insulin resistance, diabetes mellitus
- Medical subject headings
- Metabolic Syndrome, Obesity, Abdominal, Hypertension, Cardiovascular Diseases, Hypercholesterolemia, Hypertriglyceridemia, Insulin Resistance, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary InterventionBehavioural
Also called Nutrition therapy, Dietary counselling, Behavioural therapy
Nutrition assessment, review of the basic principles of dietary intervention for metabolic syndrome with an emphasis on the clinical risk factors identified for each individual, joint goal setting to determine what dietary changes are feasible, considering intention and barriers to dietary behaviour change.
Exercise Prescription and Fitness ProgramBehavioural
Also called Exercise plan, physical activity intervention
Exercise tests (aerobic fitness, muscular and flexibility tests) recommended by the Canadian Society of Exercise Physiology (CSEP), followed by an individualized exercise plan including fitness assessments.
| Study group | Role | What they receive |
|---|---|---|
| Diet and exercise | Experimental | A combined diet and exercise program tailored to individuals incorporating behavioural modification support Receives: Behavioral: Dietary Intervention; Behavioral: Exercise Prescription and Fitness Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the Diet Intervention
Percentage of the prescribed diet visits visits attended over 12 months. Each participant was to attend a total of 21 prescribed diet visits over 12 months.
Measured: At 12 months
Feasibility of the Exercise Intervention
Percentage of the prescribed exercise visits attended over 12 months. Each participant was to attend a total of 21 prescribed exercise visits over 12 months.
Measured: At 12 months
Number of Participants That Have Reversal of Metabolic Syndrome
Metabolic syndrome is defined as having 3/5 of the following: elevated blood pressure (or on medication), elevated blood sugars (or on medication), elevated triglycerides (or on medication), low HDL-C and a large waist circumference. Reversal of metabolic syndrome is defined as having less than 3/5 criteria
Measured: At 12 months compared to baseline measures
Secondary outcomes (6)
Percentage of Participants With Improvements in at Least One Individual Components of Metabolic Syndrome
Improvements in blood pressure (or elimination of medication), blood sugars (or elimination of medication), triglycerides (or elimination of medication), HDL-C and waist circumference
Measured: At 12 months compared to baseline
Change From Baseline in Diet Quality-Canadian Healthy Eating Index
Canadian Health Eating Index (HEI-C) is reported on a 100 point score with a higher score indicating a better outcome. A higher score means a better outcome. HEI-C is on a 100 point score.
Measured: Change at 12 months compared to baseline
Change From Baseline in Diet Quality-Mediterranean Diet Score
Mediterranean Diet Score (MDS) is reported on a 0-14 point score with a higher score indicating a better outcome.
Measured: Change at 12 months compared to baseline
Change From Baseline in Aerobic Capacity
Estimated maximal oxygen consumption (VO2 max) standardized to age and sex
Measured: Change at 12 months compared to baseline
Changes in Risk of Myocardial Infarction and Cardiac Events
Changes in PROCAM score, which estimates the risk of a myocardial infarction or dying from an acute coronary event within the next 10 years. Similar to Framingham risk score but for metabolic syndrome. A lower score means a better outcome. PROCAM score varies from 0-87,0 means there are no risk factors (pt is younger than 39), while 87 means the patient is a smoker and older than 60 years and presents all risk factors
Measured: Change at 12 months compared to baseline
Changes in Continuous Metabolic Syndrome Risk Score
Metabolic syndrome risk score is a composite continuous score that measures the severity of metabolic syndrome as a continuous variable rather than dichotomized with arbitrary cut-points . The score is the principal component of waist circumference, glucose, systolic blood pressure, triglycerides. It has a mean of 0 and a standard deviation of 1 with higher score meaning greater risk. Reference Hillier TA, et al., Practical way to assess metabolic syndrome using a continuous score obtained from principal components analysis. Diabetologia (2006) 49:1528-1535
Measured: Change at 12 months compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startOct 2012
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daren K. Heyland
- Sponsor type
- University, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton
- Responsible party
- Sponsor-investigator, Daren K. Heyland, Clinical Evaluation Research Unit at Kingston General Hospital
- Investigators
- Khush Jeejeebhoy, MD, Study director, University of TorontoPaula Brauer, Study chair, University of GuelphAngelo Tremblay, Study chair, Laval UniversityDavid Mutch, PhD, Principal investigator, University of GuelphDoug Klein, MD, Principal investigator, University of Alberta, Edmonton, AlbertaLew Pliamm, MD, Principal investigator, Canadian Phase OnwardCaroline Rheaume, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616563
- Sponsor's protocol ID
- CHANGE
- Acronym
- CHANGE
- Status last verified
- Jan 2021
- First submitted
- 7 Jun 2012
- Last updated
- 21 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Mensah GA, Brown DW. An overview of cardiovascular disease burden in the United States. Health Aff (Millwood). 2007 Jan-Feb;26(1):38-48. doi: 10.1377/hlthaff.26.1.38.
PubMed 17211012Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.
PubMed 11832527Balducci S, Zanuso S, Nicolucci A, De Feo P, Cavallo S, Cardelli P, Fallucca S, Alessi E, Fallucca F, Pugliese G; Italian Diabetes Exercise Study (IDES) Investigators. Effect of an intensive exercise intervention strategy on modifiable cardiovascular risk factors in subjects with type 2 diabetes mellitus: a randomized controlled trial: the Italian Diabetes and Exercise Study (IDES). Arch Intern Med. 2010 Nov 8;170(20):1794-803. doi: 10.1001/archinternmed.2010.380.
PubMed 21059972Gouveri ET, Tzavara C, Drakopanagiotakis F, Tsaoussoglou M, Marakomichelakis GE, Tountas Y, Diamantopoulos EJ. Mediterranean diet and metabolic syndrome in an urban population: the Athens Study. Nutr Clin Pract. 2011 Oct;26(5):598-606. doi: 10.1177/0884533611416821.
PubMed 21947643Kastorini CM, Milionis HJ, Esposito K, Giugliano D, Goudevenos JA, Panagiotakos DB. The effect of Mediterranean diet on metabolic syndrome and its components: a meta-analysis of 50 studies and 534,906 individuals. J Am Coll Cardiol. 2011 Mar 15;57(11):1299-313. doi: 10.1016/j.jacc.2010.09.073.
PubMed 21392646Engstrom G, Hedblad B, Janzon L. Hypertensive men who exercise regularly have lower rate of cardiovascular mortality. J Hypertens. 1999 Jun;17(6):737-42. doi: 10.1097/00004872-199917060-00003.
PubMed 10459869Rubenfire M, Mollo L, Krishnan S, Finkel S, Weintraub M, Gracik T, Kohn D, Oral EA. The metabolic fitness program: lifestyle modification for the metabolic syndrome using the resources of cardiac rehabilitation. J Cardiopulm Rehabil Prev. 2011 Sep-Oct;31(5):282-9. doi: 10.1097/HCR.0b013e318220a7eb.
PubMed 21734589Cardiometabolic Risk Working Group: Executive Committee; Leiter LA, Fitchett DH, Gilbert RE, Gupta M, Mancini GB, McFarlane PA, Ross R, Teoh H, Verma S, Anand S, Camelon K, Chow CM, Cox JL, Despres JP, Genest J, Harris SB, Lau DC, Lewanczuk R, Liu PP, Lonn EM, McPherson R, Poirier P, Qaadri S, Rabasa-Lhoret R, Rabkin SW, Sharma AM, Steele AW, Stone JA, Tardif JC, Tobe S, Ur E. Cardiometabolic risk in Canada: a detailed analysis and position paper by the cardiometabolic risk working group. Can J Cardiol. 2011 Mar-Apr;27(2):e1-e33. doi: 10.1016/j.cjca.2010.12.054.
PubMed 21459257Fung CS, Mercer SW. A qualitative study of patients' views on quality of primary care consultations in Hong Kong and comparison with the UK CARE Measure. BMC Fam Pract. 2009 Jan 27;10:10. doi: 10.1186/1471-2296-10-10.
PubMed 19173724Lusis AJ, Attie AD, Reue K. Metabolic syndrome: from epidemiology to systems biology. Nat Rev Genet. 2008 Nov;9(11):819-30. doi: 10.1038/nrg2468.
PubMed 18852695Imai K, Kricka LJ, Fortina P. Concordance study of 3 direct-to-consumer genetic-testing services. Clin Chem. 2011 Mar;57(3):518-21. doi: 10.1373/clinchem.2010.158220. Epub 2010 Dec 15.
PubMed 21159896Maitland SB, Brauer P, Mutch DM, Royall D, Klein D, Tremblay A, Rheaume C, Jeejeebhoy K. Exploratory analysis of the variable response to an intensive lifestyle change program for metabolic syndrome. BMC Prim Care. 2024 Oct 1;25(1):357. doi: 10.1186/s12875-024-02608-w.
PubMed 39354341
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canadian Health Advanced By Nutrition and Graded Exercise: CHANGE Health Paradigm
- ClinicalTrials.gov ID
- NCT01616563
- Acronym / sponsor ID
- CHANGE / CHANGE
- Conditions
- Metabolic Syndrome
- Keywords
- central obesity, abdominal obesity, hypertension, cardiovascular disease, high cholesterol, high triglycerides, insulin resistance, diabetes mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- Daren K. HeylandUniversity, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton
- Study start
- Oct 2012 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 12 Jun 2012 (estimated)
- Results
- Posted 21 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of the CHANGE initiative is to change the delivery of care in primary care clinics to treat disease by reducing reliance on drugs and hospitals through the promotion of scientifically validated nutritional concepts and exercise. Specifically, the objective is to identify patients from primary care clinics with metabolic syndrome who are not morbidly obese and use diet and exercise interventions to reverse the changes, reduce reliance on pharmacotherapy and prevent progression to diabetes and cardiovascular disease.
Detailed description
Hypertension, cardiovascular disease, strokes, diabetes and their complications including renal failure and neuropathy are major contributors to healthcare costs1. Metabolic Syndrome, a widespread genetic trait refers to a group of factors that increase risk for these diseases. Progression of the components of the metabolic syndrome can be significantly reduced by dietary manipulation and exercise.
The aging population, with both metabolic syndrome and muscular weakness, is going to result in an enormous social and financial burden not only for medical care but also for families caring for such patients. Existing knowledge would suggest that dietary modification and exercise training would substantially reduce the costs and complications of these medical conditions.
The Canadian Guidelines for the diagnosis and management of cardiometabolic risk identify patients with metabolic syndrome who have an increased risk of cardiac and vascular disease and diabetes but the application of these results to prevent disease has been a dismal failure in general and in particular, in our country.
The current model of advice about preventive care is through family doctors (FD) in the primary care setting. FDs tend not to advise their patients about diet and exercise for a variety of reasons including a lack of education about these modalities, a lack of support from professionals qualified to assess and advise about diet and exercise, the belief that drugs are better, lack of time and a lack of reimbursement in addition to patient barriers to adoption. Although other factors, such has smoking, hypercoagulability and increased expression of proinflammatory cytokines increase cardiometabolic risk, these changes are closely related to the metabolic syndrome. "Health behavior interventions" are identified as critical to preventing the occurrence of cardiovascular disease and diabetes. These interventions can be associated with appropriate pharmacotherapy where required. The guidelines recommend a multidisciplinary team to manage these interventions. In addition it is also recommended that ethnicity be considered in these interventions.
The various traits associated with the metabolic syndrome are strongly influenced by genetic factors, i.e. the heritability of abdominal obesity and insulin resistance are estimated to be as high as 70%. Accordingly, the investigators propose to examine numerous genetic polymorphisms (also referred to as markers) that have been linked to the various traits associated with metabolic syndrome in a sub study. It is hypothesized that these markers can be used as a means to better predict the variable responses observed in individuals following a lifestyle intervention. Several companies have begun to commercialize direct-to-consumer genetic-testing to provide nutritional counseling to individuals based on the analysis of a small subset of polymorphisms11; however, there is an absence of scientific research to either support or refute the value of genetic markers for predicting an individual's response. Considering common genetic markers in a lifestyle intervention study will enable us to assess their value for predicting response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diet and exercise | Experimental | Behavioral: Dietary Intervention, Behavioral: Exercise Prescription and Fitness ProgramA combined diet and exercise program tailored to individuals incorporating behavioural modification support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age >/= 18 years old
- Fasting Blood Glucose >/= 5.6 mmol/L or receiving pharmacotherapy
- Blood Pressure of >/= 130/85 mm Hg or receiving pharmacotherapy
- Triglyceride of >/= 1.7 mmol/L or receiving pharmacotherapy
- HDL-C < 1.0 mmol/L Males and < 1.3 mmol/L females
Key exclusion criteria (18 listed)
- Inability to speak, read or understand English and/or French for the Laval University participants.
- Having a medical or physical condition that makes moderate intensity physical activity difficult or unsafe.
- Diagnosis of Type 1 Diabetes Mellitus
- Type 2 diabetes mellitus only if any one of the following are present
- Significant medical co-morbidities, including uncontrolled metabolic disorders (e.g., thyroid, renal , liver), heart disease, stroke and ongoing substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary InterventionAlso: Nutrition therapy, Dietary counselling, Behavioural therapyNutrition assessment, review of the basic principles of dietary intervention for metabolic syndrome with an emphasis on the clinical risk factors identified for each individual, joint goal setting to determine what dietary changes are feasible, considering intention and barriers to dietary behaviour change. | Behavioural | Diet and exercise |
| Exercise Prescription and Fitness ProgramAlso: Exercise plan, physical activity interventionExercise tests (aerobic fitness, muscular and flexibility tests) recommended by the Canadian Society of Exercise Physiology (CSEP), followed by an individualized exercise plan including fitness assessments. | Behavioural | Diet and exercise |
Primary outcome
Feasibility of the Diet Intervention
Time frame: At 12 months
Percentage of the prescribed diet visits visits attended over 12 months. Each participant was to attend a total of 21 prescribed diet visits over 12 months.
Feasibility of the Exercise Intervention
Time frame: At 12 months
Percentage of the prescribed exercise visits attended over 12 months. Each participant was to attend a total of 21 prescribed exercise visits over 12 months.
Number of Participants That Have Reversal of Metabolic Syndrome
Time frame: At 12 months compared to baseline measures
Metabolic syndrome is defined as having 3/5 of the following: elevated blood pressure (or on medication), elevated blood sugars (or on medication), elevated triglycerides (or on medication), low HDL-C and a large waist circumference. Reversal of metabolic syndrome is defined as having less than 3/5 criteria
6 secondary outcomes
Percentage of Participants With Improvements in at Least One Individual Components of Metabolic Syndrome
Time frame: At 12 months compared to baseline
Change From Baseline in Diet Quality-Canadian Healthy Eating Index
Time frame: Change at 12 months compared to baseline
Change From Baseline in Diet Quality-Mediterranean Diet Score
Time frame: Change at 12 months compared to baseline
Change From Baseline in Aerobic Capacity
Time frame: Change at 12 months compared to baseline
Changes in Risk of Myocardial Infarction and Cardiac Events
Time frame: Change at 12 months compared to baseline
Changes in Continuous Metabolic Syndrome Risk Score
Time frame: Change at 12 months compared to baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17211012Mensah GA, Brown DW. An overview of cardiovascular disease burden in the United States. Health Aff (Millwood). 2007 Jan-Feb;26(1):38-48. doi: 10.1377/hlthaff.26.1.38.
- Background: PubMed 11832527Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.
- Background: PubMed 21059972Balducci S, Zanuso S, Nicolucci A, De Feo P, Cavallo S, Cardelli P, Fallucca S, Alessi E, Fallucca F, Pugliese G; Italian Diabetes Exercise Study (IDES) Investigators. Effect of an intensive exercise intervention strategy on modifiable cardiovascular risk factors in subjects with type 2 diabetes mellitus: a randomized controlled trial: the Italian Diabetes and Exercise Study (IDES). Arch Intern Med. 2010 Nov 8;170(20):1794-803. doi: 10.1001/archinternmed.2010.380.
- Background: PubMed 21947643Gouveri ET, Tzavara C, Drakopanagiotakis F, Tsaoussoglou M, Marakomichelakis GE, Tountas Y, Diamantopoulos EJ. Mediterranean diet and metabolic syndrome in an urban population: the Athens Study. Nutr Clin Pract. 2011 Oct;26(5):598-606. doi: 10.1177/0884533611416821.
- Background: PubMed 21392646Kastorini CM, Milionis HJ, Esposito K, Giugliano D, Goudevenos JA, Panagiotakos DB. The effect of Mediterranean diet on metabolic syndrome and its components: a meta-analysis of 50 studies and 534,906 individuals. J Am Coll Cardiol. 2011 Mar 15;57(11):1299-313. doi: 10.1016/j.jacc.2010.09.073.
- Background: PubMed 10459869Engstrom G, Hedblad B, Janzon L. Hypertensive men who exercise regularly have lower rate of cardiovascular mortality. J Hypertens. 1999 Jun;17(6):737-42. doi: 10.1097/00004872-199917060-00003.
- Background: PubMed 21734589Rubenfire M, Mollo L, Krishnan S, Finkel S, Weintraub M, Gracik T, Kohn D, Oral EA. The metabolic fitness program: lifestyle modification for the metabolic syndrome using the resources of cardiac rehabilitation. J Cardiopulm Rehabil Prev. 2011 Sep-Oct;31(5):282-9. doi: 10.1097/HCR.0b013e318220a7eb.
- Background: PubMed 21459257Cardiometabolic Risk Working Group: Executive Committee; Leiter LA, Fitchett DH, Gilbert RE, Gupta M, Mancini GB, McFarlane PA, Ross R, Teoh H, Verma S, Anand S, Camelon K, Chow CM, Cox JL, Despres JP, Genest J, Harris SB, Lau DC, Lewanczuk R, Liu PP, Lonn EM, McPherson R, Poirier P, Qaadri S, Rabasa-Lhoret R, Rabkin SW, Sharma AM, Steele AW, Stone JA, Tardif JC, Tobe S, Ur E. Cardiometabolic risk in Canada: a detailed analysis and position paper by the cardiometabolic risk working group. Can J Cardiol. 2011 Mar-Apr;27(2):e1-e33. doi: 10.1016/j.cjca.2010.12.054.
- Background: PubMed 19173724Fung CS, Mercer SW. A qualitative study of patients' views on quality of primary care consultations in Hong Kong and comparison with the UK CARE Measure. BMC Fam Pract. 2009 Jan 27;10:10. doi: 10.1186/1471-2296-10-10.
- Background: PubMed 18852695Lusis AJ, Attie AD, Reue K. Metabolic syndrome: from epidemiology to systems biology. Nat Rev Genet. 2008 Nov;9(11):819-30. doi: 10.1038/nrg2468.
- Background: PubMed 21159896Imai K, Kricka LJ, Fortina P. Concordance study of 3 direct-to-consumer genetic-testing services. Clin Chem. 2011 Mar;57(3):518-21. doi: 10.1373/clinchem.2010.158220. Epub 2010 Dec 15.
- Derived from this study: PubMed 39354341Maitland SB, Brauer P, Mutch DM, Royall D, Klein D, Tremblay A, Rheaume C, Jeejeebhoy K. Exploratory analysis of the variable response to an intensive lifestyle change program for metabolic syndrome. BMC Prim Care. 2024 Oct 1;25(1):357. doi: 10.1186/s12875-024-02608-w.
- Individual participant dataSharing planned: No
Related trials for Metabolic Syndrome
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
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.
Khush Jeejeebhoy, MD study director
University of Toronto
Paula Brauer study chair
University of Guelph
Angelo Tremblay study chair
Laval University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Intervention and Exercise Prescription and Fitness Program in people with Metabolic Syndrome, run by Daren K. Heyland at 3 sites 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 9 inclusion and 18 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: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Yes. Results are posted in the registry (first posted 21 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Feasibility of the Diet Intervention (time frame: At 12 months). 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 NCT01616563, which also lists 12 linked publications.
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 21 Feb 2021.