Metabolic Syndrome
Conditions
Keywords
central obesity, abdominal obesity, hypertension, cardiovascular disease, high cholesterol, high triglycerides, insulin resistance, diabetes mellitus
Brief 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. 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.
Interventions
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 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.
Sponsors
Study design
Eligibility
Inclusion criteria
* 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: * 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.
Exclusion criteria
* 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 1. Proliferative diabetic retinopathy 2. Nephropathy (Suggested parameters: serum creatinine \> 160 µmol/L) 3. Clinically manifest neuropathy defined as absent ankle jerks 4. Severe fasting hyperglycemia \> 11 mmol/L 5. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the Diet Intervention | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Aerobic Capacity | Change at 12 months compared to baseline | Estimated maximal oxygen consumption (VO2 max) standardized to age and sex |
| Percentage of Participants With Improvements in at Least One Individual Components of Metabolic Syndrome | At 12 months compared to baseline | Improvements in blood pressure (or elimination of medication), blood sugars (or elimination of medication), triglycerides (or elimination of medication), HDL-C and waist circumference |
| Changes in Continuous Metabolic Syndrome Risk Score | Change at 12 months compared to baseline | 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 |
| Changes in Risk of Myocardial Infarction and Cardiac Events | Change at 12 months compared to baseline | 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 |
| Change From Baseline in Diet Quality-Canadian Healthy Eating Index | Change at 12 months compared to baseline | 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. |
| Change From Baseline in Diet Quality-Mediterranean Diet Score | Change at 12 months compared to baseline | Mediterranean Diet Score (MDS) is reported on a 0-14 point score with a higher score indicating a better outcome. |
Countries
Canada
Participant flow
Recruitment details
A total of 305 patients were recruited from 3 participating primary care clinics from Oct 2012 to December 2014. Of these, 12 patients were excluded, 10 that no longer met the inclusion criteria and 2 that met an exclusion criteria by the time the study started. A total of 293 patients were included in the analysis.
Participants by arm
| Arm | Count |
|---|---|
| Diet and Exercise Intervention A combined diet and exercise program tailored to individuals incorporating behavioural modification support | 293 |
| Total | 293 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 40 |
Baseline characteristics
| Characteristic | Diet and Exercise Intervention |
|---|---|
| Age, Continuous | 59.1 years STANDARD_DEVIATION 9.7 |
| Body Mass Index | 31.9 kg/m^2 STANDARD_DEVIATION 3.3 |
| Estimated V02 Max percentile | 46.8 % STANDARD_DEVIATION 24 |
| Healthy Eating Index-Canadian | 57.9 units on a scale STANDARD_DEVIATION 14.2 |
| Mediterranean Diet Score | 4.7 units on a scale STANDARD_DEVIATION 1.6 |
| PROCAM risk % | 8.2 % STANDARD_DEVIATION 6.4 |
| Region of Enrollment Canada | 293 participants |
| Sex: Female, Male Female | 152 Participants |
| Sex: Female, Male Male | 141 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: At 12 months
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Diet and Exercise Intervention | Feasibility of the Diet Intervention | 4782 prescribed diet visits |
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.
Time frame: At 12 months
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Diet and Exercise Intervention | Feasibility of the Exercise Intervention | 4038 prescribed exercise visits |
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
Time frame: At 12 months compared to baseline measures
Population: Combined diet and exercise program
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Diet and Exercise Intervention | Number of Participants That Have Reversal of Metabolic Syndrome | 48 Participants |
Change From Baseline in Aerobic Capacity
Estimated maximal oxygen consumption (VO2 max) standardized to age and sex
Time frame: Change at 12 months compared to baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Diet and Exercise Intervention | Change From Baseline in Aerobic Capacity | 15.6 percentile |
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.
Time frame: Change at 12 months compared to baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Diet and Exercise Intervention | Change From Baseline in Diet Quality-Canadian Healthy Eating Index | 9.6 score on a scale out of 100 |
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.
Time frame: Change at 12 months compared to baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Diet and Exercise Intervention | Change From Baseline in Diet Quality-Mediterranean Diet Score | 1.4 score on a scale out of 14 |
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
Time frame: Change at 12 months compared to baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Diet and Exercise Intervention | Changes in Continuous Metabolic Syndrome Risk Score | 0.4 z-score |
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
Time frame: Change at 12 months compared to baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Diet and Exercise Intervention | Changes in Risk of Myocardial Infarction and Cardiac Events | 1.4 percentage |
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
Time frame: At 12 months compared to baseline
Population: % participants that had improvement in metabolic syndrome components
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Diet and Exercise Intervention | Percentage of Participants With Improvements in at Least One Individual Components of Metabolic Syndrome | 106 Participants |