Targeting Risk Factors for Diabetes in Subjects With Normal Blood Cholesterol Using Omega-3 Fatty Acids
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- STATUS
- Recruiting
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- End date
- Oct 31, 2025
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- participants needed
- 48
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- sponsor
- Institut de Recherches Cliniques de Montreal
Summary
Every 3 minutes a new case of
Paradoxically however, while lowering blood LDL, commonly known as "bad cholesterol", is
protective against
To date, it is unclear why lowering blood LDL is associated with higher risk for
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
Thus the objectives of this clinical trial to be conducted in 48 subjects with normal blood LDL are to explore if:
- Subjects with higher
LDL receptors and LDL entry into fat tissue have higher risk factors for T2D compared to subjects with lowerLDL receptors and LDL entry into fat tissue - 6-month supplementation of
omega-3 fromfish 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.
Description
Type 2 (T2D) and
The central hypothesis examined in this trial is that upregulating receptor-mediated uptake
of LDL on white adipose tissue provokes the activation of an innate immunity pathway (the
Nucleotide-binding domain and Leucine-rich repeat Receptor, containing a Pyrin domain 3
(NLRP3)
To examine this hypothesis in vivo, ex vivo and in vitro, a clinical trial in conjunction
with mechanistic basic research studies have been initiated at the Montreal Clinical Research
Institute (IRCM). Forty eight volunteers will be recruited through advertisements in
French/English newspapers and online (e.g. Google, Facebook) and placed on a 6-month
supplementation of 3.6 g
The duration of this study is about 8 months (33 weeks) divided into 5 parts:
- Screening and evaluation of eligibility for the study
- Weight stabilisation (+/- 2 kg change over 4 weeks) and confirmation of eligibility after a medical examination by IRCM physician collaborators.
- Baseline testing over 2 days (1- 4 weeks apart) to assess participants risk factors for
T2D: white adipose tissue NLRP3
inflammasome activity, white adipose tissue physiology and function (ex vivo after a subcutaneousneedle biopsy ), systemicinflammation , dietary fat clearance (after a high fat meal), andinsulin secretion andsensitivity (by gold-standard Botnia clamp technique). Participants will also be phenotyped for body composition (by dual energyx-ray absorptiometry), resting energy expenditure (byindirect calorimetry ), dietary intake (by 3-day dietary journals) and physical activity level (by a questionnaire). - 24-week intervention with
omega-3 fatty acid supplementation (3.6 geicosapentaenoic acid (EPA) and docosahexaenoic (DHA), 2:1) - Post intervention testing starting over 2 days (1- 4 weeks apart) to assess risk factors for T2D that were measured at baseline.
Investigators hypothesize that subjects with low plasma PCSK9 (i.e. with higher white adipose
tissue LDLR and CD36) will have higher risk factors for T2D at baseline and that the
Details
Condition |
NIDDM, |
---|---|
Age | 45years - 74years |
Treatment |
|
Clinical Study Identifier | NCT04485871 |
Sponsor | Institut de Recherches Cliniques de Montreal |
Last Modified on | 19 February 2024 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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