Diet Impact on Hepatic Transcriptomics and Lipidomics in Pre-diabetes

Plain-language summary

This study examines how low-fat and high-fat diets affect the liver's gene expression (transcriptomics) and fat profile (lipidomics) in people with pre-diabetes. It enrolls non-smoking men and women aged 18 to 60 who meet specific metabolic criteria. It is a study with no assigned phase and is currently active but not recruiting new participants (active, not recruiting).

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Active, not recruiting

Sponsor

Laval University

Intervention

Low fat diet, High fat diet

Start date

6/9/2023

Estimated completion

12/31/2025

Countries

Canada

Related genes

Locations

• Québec, Canada

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Males and females 18 to 60 years of age.
* Non-smoker
* Waist circumference \> 102 cm for men and \> 88 cm for women.
* Plasma triglyceride levels \> 1,7 mmol/L at the screening visit.
* Fasting plasma glucose levels \> 6,1 mmol/L at the screening visit.
* Fasting plasma insulin levels above the upper limit of normal at the screening visit.
* Subjects must be willing to give written informed consent and able to adhere to the diet schedule and visit schedule.
* Patients should be otherwise healthy, without abnormal renal function or coagulation.

Exclusion Criteria:

* Patients with extreme dyslipidemias, such as familial hypercholesterolemia will be excluded.
* Subjects will be excluded if they have cardiovascular disease (CHD, cerebrovascular disease or peripheral arterial disease) or if they are taking other medications known to affect lipoprotein metabolism (eg. steroids, beta blockers, thiazide diuretics, other lipid lowering agents, significant alcohol intake etc.).
* Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
* Individuals with a history of mental instability, drug or alcohol abuse within the past 2 years or individuals who have been treated or are being treated for severe psychiatric illness that, in the opinion of the investigator, may interfere with optimal participation in the study.
* Disorders of the hematologic, digestive, or central nervous systems, including cerebrovascular disease and degenerative disease, that would limit study evaluation or participation.
* Known impairment of renal function (creatinine \>2.0 mg/dL), dysproteinemia, nephrotic syndrome, or other renal disease.
* Subjects with coagulopathy (prothrombin time \[PT\] or partial thromboplastin time \[PTT\] at Visit 1 higher than 1.5 times control).
* Patients who are known to have tested positive for human immunodeficiency virus (HIV).
* Patients who have used any investigational drug within 30 days of the first clinic visit.
* Diabetic patients are excluded from the study. Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins. Clinically euthyroid subjects on replacement doses of thyroid hormone are eligible for enrollment.