Low Fat vs High Fat Diet for Prediabetes
(DGENE-NAFLD Trial)
Trial Summary
What is the purpose of this trial?
Non-alcoholic fatty liver disease (NAFLD) is one of the most common liver diseases, affecting 25% to 30% of the global population and nearly one third of the population in North America. NAFLD is defined as an excessive accumulation of lipids within hepatocytes in the absence of significant alcohol consumption or other causes of chronic liver disease. These patients usually present with hepatic steatosis observed on imaging studies and elevated liver enzymes with clinical features of insulin resistance (IR), including pre-diabetes, type 2 diabetes mellitus (T2DM), arterial hypertension, dyslipidemia, and visceral obesity. The minimum criterion for a histologic diagnosis of NAFLD is \>5 percent steatotic hepatocytes in a liver tissue section. The exact mechanism for the development of NAFLD is unclear, although the current evidence indicates that it is likely a complex interplay among neurohormones, intestinal dysbiosis, nutrition, and genetics. IR plays a crucial role in NAFLD pathophysiology mainly by increasing adipocyte lipolysis, resulting in the circulation of more free fatty acids available for hepatic uptake and increasing hepatic de novo lipogenesis. There is yet no approved pharmacologic option for the treatment of NAFLD. Current international guidelines on NAFLD emphasize the importance of lifestyle modifications for all patients with NAFLD and recommend 7-10% of weight loss and a "healthy diet", without suggesting any particular diet. Recent data provide some support for the beneficial role of low carbohydrate (CHO)/high unsaturated fatty acid (both monounsaturated (MUFAs) and polyunsaturated (PUFAs)) dietary patterns for decreasing hepatic steatosis. This proposal addresses this important research gap by leading to advances regarding the impact of a short-term low CHO/high PUFAs/MUFAs dietary intervention on improving hepatic gene expression profiles and lipid composition in individuals with pre-diabetes. The proposed study is unique because all meals and foods will be provided to participants under carefully controlled isocaloric conditions to maintain a constant bodyweight with optimal energy and macronutrient intake control. The primary objective of the proposed research is to investigate how replacement of dietary CHOs by unsaturated fatty acids (both PUFAs and MUFAs) affects liver fat composition and liver transcriptomics in subjects with pre-diabetes.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking medications that affect lipoprotein metabolism, like steroids or beta blockers.
What data supports the effectiveness of the treatment for prediabetes?
Research suggests that healthy eating habits, including diets low in saturated fats and high in fiber, can help manage prediabetes. While specific data on low-fat versus high-fat diets is unclear, plant-based and low-carbohydrate diets have shown benefits in reducing cardiovascular risk factors associated with prediabetes.12345
Is a low-fat or high-fat diet safe for people with prediabetes?
How does the high fat vs low fat diet treatment for prediabetes differ from other treatments?
This treatment is unique because it directly compares the effects of high fat and low fat diets on prediabetes, focusing on dietary composition rather than medication. Unlike traditional low-fat, high-carbohydrate diets often recommended for diabetes, this study explores whether a high-fat diet might offer benefits in managing prediabetes, which is a novel approach given the usual emphasis on reducing fat intake.710111213
Research Team
Patrick Couture, MD, PhD
Principal Investigator
Laval University
Eligibility Criteria
This trial is for adults aged 18-60 with pre-diabetes, indicated by specific blood sugar and insulin levels. Participants must have a waist size over set thresholds, elevated triglycerides, be non-smokers, and in general good health without severe kidney or coagulation issues. They should not have HIV, uncontrolled endocrine diseases, recent investigational drug use, mental instability or substance abuse history.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dietary Intervention
Participants consume a controlled diet with either high or low fat content for 3 days
Follow-up
Participants are monitored for changes in hepatic gene expression and lipid composition
Treatment Details
Interventions
- High fat diet
- Low fat diet
Find a Clinic Near You
Who Is Running the Clinical Trial?
Laval University
Lead Sponsor