ApoB-lipoproteins and risk for type 2 diabetes Nutritional, Metabolic, Endocrine ApoB-lipoproteins and risk for type 2 diabetes
Conditions
Interventions
Participants are asked to follow a hypocaloric diet for six months. The diet is administered during individual sessions by two registered dietitians. Daily energy needs are calculated as basal metabol
Sponsors
Montreal Clinical Research Institute (Institut de Recherches cliniques de Montréal (IRCM))
Université de Montréal
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Having a body mass index (BMI) > 27 kg/m2 2. Aged between 45 and 74 years 3. Having confirmed menopausal status (FSH = 30 U/l) for women 4. Non-smoker 5. Sedentary (less than 2 hours of structured physical exercise (ex: sports club) per week) 6. Low alcohol consumption: less than 2 alcoholic drinks/day
Exclusion criteria
Exclusion criteria: 1. Abnormal physiological values necessitating rapid medical intervention: 1.1. Elevated risk of cardiovascular disease (>20% of calculated Framingham Risk Score) 1.2. Fasting glycaemia > 7.0 mmol/L 1.3. Blood pressure >160/100 mmHg 1.4. Hb 135 µmol/L 2. AST or ALT > 3 times upper normal level 3. Suffering from: 3.1. Claustrophobia 3.2. Type 1 or 2 diabetes 3.3. Un-treated thyroid disease 3.4. Cardiovascular or vascular disease with an event occurring less than 6 months ago 3.5. Event of cancer in the last 3 years 3.6. Chronic inflammatory disease such as rheumatoid arthritis or lupus 4. Abnormal blood coagulation 5. Presently following or have followed in the past 3 months : 5.1. Oestrogen treatment 5.2. Hormone replacement therapy (except thyroid hormone at a stable dose) 5.3. Corticosteroids, nerve sedatives 5.4. Hypertension treatment 5.5. Hyperlipidemia treatment 5.6. Anticoagulant treatment 5.7. Weight-loss, psycho-active or adrenergic agonist medications 6. Substance abuse 7. Have exceeded the annual total allowed radiation dose (like X-ray scans and/or tomography in the previous year or in the year to come) according to the physician’s judgement. 8. Lack of time to participate in the full length of the study (33 weeks) 9. All other medical or psychological conditions deemed inappropriate according to the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Plasma apoB-lipoprotein profile is measured using an automated analyzer at baseline and seven months 2. Body composition is measured using dual-energy X-ray absorptiometry (DXA) at baseline and seven months 3. Systemic glucose-induced insulin secretion and sensitivity is measured using a Botnia clamp at baseline and seven months 4. Plasma inflammatory markers are measured using commercial hsELISA kits on blood samples at baseline and seven months 5. Postprandial plasma clearance and oxidation rates of a 13C-labeled high fat meal is measured using isotope ratio mass spectrometry at baseline and seven months 6. Gynoid white adipose tissue function is measured ex vivo using in situ lipoprotein-lipase activity technique at baseline and seven months 7. Gynoid white adipose tissue genetic and protein expression of inflammatory markers is measured using RT-PCR and immunoblot, respectively at baseline and seven months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Blood pressure is measured using an automated machine at baseline and seven months 2. Waist and hip circumferences is measured using a measure tape at baseline and seven months 3. Metabolic rate and macronutrient oxidation rates are measured using indirect calimetry at baseline and seven months 4. Dietary intake is measured using 3-day food intake records at baseline and six months (directly at the end of the hypocaolic diet) 5. Plasma C-peptide is measured using a commercial RIA kit at baseline and seven months 6. Fatty acids are measured using a commercial kit at baseline and seven months 7. ApoB48 is measured using a commercial hsELISA kit at baseline and seven months 8. apoA-1 is measured using an automated analyzer at baseline and seven months 9. PCSK9 is measured using a commercial hsELISA kit at baseline and seven months | — |
Countries
Canada
Outcome results
None listed