Lipid Metabolism Disorders, Polycystic Ovary Syndrome
Conditions
Keywords
Polycystic Ovary Syndrome, metabolic and cardiovascular diseases, diabetes, obesity
Brief summary
The primary objective in this proposed study is to determine the effect of dietary fish oil supplementation compared to standard care metformin treatment, and fish oil in combination with metformin on plasma lipids and apoB-remnant lipoprotein metabolism in overweight-obese young women with PCOS.
Detailed description
Specific Objectives; 1. To determine the effect of dietary fish oil supplementation, metformin, and fish oil in combination with metformin on fasting and non-fasting plasma TG, apoB48 and apoB100-lipoprotein concentrations. 2. To determine the physiological mechanisms associated with the effect of dietary fish oil supplementation and metformin on in vivo plasma lipid and apoB-lipoprotein kinetics. We will quantitate the in vivo production and kinetics of plasma TG, apoB48 and apoB100-lipoproteins in plasma and isolated lipoprotein fractions, using established methods. 3. To explore the effects of dietary fish oil supplementation, metformin and fish oil in combination with metformin, on plasma insulin and testosterone, and the association with changes in plasma lipids and apoB-lipoprotein metabolism.
Interventions
DRUGMetformin
Manufacturer's standard 500 mg. Submission Control No.:128147
COMBINATION_PRODUCTFish Oil and Metformin
Combo of 2 other arms
DIETARY_SUPPLEMENTFish Oil
NPN: 80028808 Licence Holder: WN Pharmaceuticals Ltd Dosage Form: Capsule, soft Recommended Route of Administration: Oral
Sponsors
Women and Children's Health Research Institute, Canada
Canadian Institutes of Health Research (CIHR)
Alberta Diabetes Institute
Heart and Stroke Foundation of Canada
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
This is a randomized open-label parallel study in overweight/obese young women with PCOS, in which the participant will be randomly assigned to one of three treatment arms
Intervention model description
Outcomes at 6 and 12 weeks will be compared to baseline values to determine the efficacy of interventions. Participants will act as their own control in each intervention
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 30 Years
Healthy volunteers
No
Inclusion criteria
* Female * Age at time of enrollment \> 18 to \<30 years * Diagnosis of PCOS: clinical and/or biochemical hyperandrogenemia and menstrual dysfunction and the exclusion of other disorders. * Overweight-obese (BMI \>25 kg/m2) high-risk metabolically-resistant young women. * Elevated fasting plasma TG (\>150 mg/dL) and apoB48-remnant cholesterol lipoproteins (\>20 ug/ml). * Impaired insulin sensitivity (glucose 100-125 mg/dL and/or insulin \>15 (uM/ml); and * May be diagnosed with T2D (blood glucose \>126 mg/dL).
Exclusion criteria
* Pregnancy * Lactating women * Recent illness that the investigator determines to pose a potential risk for the participant * Concomitant medications that influence metabolism (e.g. statins) * Excessive alcohol consumption, as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Triglycerides and apoB-lipoprotein remnants in non-fasting and fasted state | At baseline and postintervention at 12 weeks | reported as mean +/- SEM |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma insulin and glucose | At baseline and postintervention at 12 weeks | reported as mean +/- SEM |
| Plasma hormones, testosterone, SHBG, Estrogen | At baseline and postintervention at 12 weeks | reported as mean +/- SEM |
Countries
Canada
Outcome results
None listed