Obesity, menopause, diabetes Nutritional, Metabolic, Endocrine Non-insulin dependent diabetes mellitus
Conditions
Interventions
All groups will be followed for 12 months.
Control group: Standard care. This group will receive the Canadian Food Guide and the Canadian Physical Activity Guide.
Groups with caloric restriction (g
Sponsors
University of Ottawa (Canada)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 10/01/2012 Participants - inclusion criteria 1. Women aged 45 years or older. 2. Overweight or obese (BMI higher than 27 kg/m2 and lower than 40 kg/m2) 3. Women with menstrual irregularities or without menses for 48 months or less 4. Non-smokers 5. Low to moderate alcohol consumers (less than 2 drinks/day) 6. Sedentary (less than 30 minutes of exercise per week) 7. Total risk score =12 from the type 2 diabetes risk assessment form Previous inclusion criteria 1. Women aged 45-55 years 2. Overweight or obese (BMI higher than 27 kg/m2 and lower than 40 kg/m2) 3. Women without menses within the last 6 to 18 months 4. Non-smokers 5. Low to moderate alcohol consumers (less than 2 drinks/day) 6. Sedentary (less than 30 minutes of exercise per week) 7. Total risk score =12 from the type 2 diabetes risk assessment form
Exclusion criteria
Exclusion criteria: 1. Pregnant or who plan to become pregnant 2. Women with medical problems and/or are taking medications which may impact on menopause or on study outcome 3. Women who had hysterectomy or bi-lateral ovariectomy 4. Known diabetes 5. Known coronary heart disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Total fat mass, measured at baseline, 4 and 12 months 2. Dual-photon x-ray (DXA) will be used to measure the following: 2.1. Body weight 2.2. Height 2.3. Bone density 2.4. Percent fat 2.5. Percent lean body mass Each subject's scan will be divided into several regions: arms, legs, trunk (pelvis, spine and ribs) and head using an on-screen image of the subject's skeleton and specific skeletal landmarks to obtain regional body composition. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes as of 10/01/2012 1. Epicardial fat measured by echocardiography of the heart (sub-samples) 2. Insulin sensitivity measured by oral glucose tolerance test A 75g oral glucose tolerance test will be performed in the morning after an overnight (12 hours) fast. Glucose will be administrated in the form of a flavoured drink (300 ml) containing 75 g of glucose. 3. Metabolic syndrome determined by using the following determinants: 3.1. Waist circumference: =88cm for women 3.2. Triglycerides = 150mg/dL (1.7mmol/L) 3.3. HDL-cholesterol <50mg/dL for women (<1.29mmol/L) 3.4. Blood pressure: systolic =130 mmHg and/or diastolic = 85mmHg 3.5. Fasting glucose =100mg/dL (5.6mmol/L) 4. Energy and metabolism: 4.1. Resting metabolic rate will be measured by using a Vmax Encore (SensorMedic) with a plexiglass hood placed over the participant?s head for 30 minutes through which fresh air will be drawn. 4.2. Accelerometry: we will use the Sensewear Armband (SWA) placed on the right arm for a period of 7 days to record the energy expenditure, activity levels and duration, caloric expenditure linked to activity, number of performed steps, sleep duration and efficacy. The Armband enables continuous physiological data collection such as movement, heat flow, skin temperature, and heart rate. 4.3. Thermic effect of food (sub-samples) will be measure with the same equipment as for the resting metabolic rate after the participant eats a standardized breakfast meal (bread, peanut butter, strawberry jam, cheddar cheese and orange juice). 4.4. Visual analogue scale: they will be used to determine the sensation and desire of eating and hunger by asking 4 questions to the participant on how they feel before and after standardized breakfast. 4.5. Double label water (sub-samples): A resting urine sample is collected before drinking the doubly-labelled water. Next, the subject drinks the doubly-labelled water. This marks day #0. The next morning, at least 14 hours after consumptio | — |
Countries
Canada
Outcome results
None listed