White Adipose Tissue LDL Receptors and Omega-3 as Modulators of the Risk for Type 2 Diabetes in Subjects With Normal Plasma LDL Cholesterol

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Every 3 minutes a new case of diabetes is diagnosed in Canada, mostly type 2 diabetes (T2D) increasing the risk for heart disease. T2D and heart disease share many common risk factors such as aging, obesity and unhealthy lifestyle. Paradoxically however, while lowering blood LDL, commonly known as bad cholesterol, is protective against heart disease, research over the past 10 years have shown that the lower is blood LDL, the higher is the chance of developing T2D. This phenomena is happening whether blood LDL is lowered by a common drug against heart disease called Statins, or by being born with certain variations in genes, some of which are very common (\ 80% of people have them). To date, it is unclear why lowering blood LDL is associated with higher risk for diabetes, and whether this can be treated naturally with certain nutrients. Investigators believe that lowering blood LDL by forcing LDL entry into the body tissue through their receptors promotes T2D. This is because investigators have shown that LDL entry into human fat tissue induces fat tissue dysfunction, which would promote T2D especially in subjects with excess weight. On the other hand, investigators have shown that omega-3 fatty acids (omega-3) can directly treat the same defects induced by LDL entry into fat tissue. Omega-3 is a unique type of fat that is found mostly in fish oil. Thus the objectives of this clinical trial to be conducted in 48 subjects with normal blood LDL are to explore if: 1. Subjects with higher LDL receptors and LDL entry into fat tissue have higher risk factors for T2D compared to subjects with lower LDL receptors and LDL entry into fat tissue 2. 6-month supplementation of omega-3 from fish oil can treat subjects with higher LDL receptors and LDL entry into fat tissue reducing their risk for T2D. This study will thus explore and attempt to treat a new risk factor for T2D using an inexpensive and widely accessible nutraceutical, which would aid in preventing T2D in humans.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 74
Healthy Volunteers: t
View:

⁃ Men and post-menopausal women:

• Having a body mass index (BMI= 25-40 kg/m2)

• Aged between 45 and 74 years

• Having confirmed menopausal status (FSH ≥ 30 U/l)

• Non-smoker

• Sedentary (less than 2 hours of structured physical exercise (ex: sports club) per week)

• Low alcohol consumption: less than 2 alcoholic drinks/day

Locations
Other Locations
Canada
Montreal Clinical Research Institute
RECRUITING
Montreal
Contact Information
Primary
Justine Fricher, MSc
justine.fricher@ircm.qc.ca
514-987-5500
Backup
Rianne Mahiout, BSc
rianne.mahiout@ircm.qc.ca
514-987-5500
Time Frame
Start Date: 2019-12-19
Estimated Completion Date: 2025-10-31
Participants
Target number of participants: 48
Treatments
Experimental: Omega-3 fatty acids
3.6 g EPA:DHA / day (2:1)
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR)
Leads: Institut de Recherches Cliniques de Montreal

This content was sourced from clinicaltrials.gov