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Behavioural Intervention
Low Fat vs High Fat Diet for Prediabetes (DGENE-NAFLD Trial)
N/A
Recruiting
Led By Patrick Couture, MD, PhD
Research Sponsored by Laval University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients should be otherwise healthy, without abnormal renal function or coagulation
Males and females 18 to 60 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at day 3 and day 20 (at the end of the two 3-day diets)
Awards & highlights
DGENE-NAFLD Trial Summary
This trial will explore how replacing carbs with unsaturated fats (PUFA & MUFA) affects liver fat & transcriptomics in pre-diabetics. Meals are provided to maintain bodyweight & energy intake.
Who is the study for?
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.Check my eligibility
What is being tested?
The study tests the effects of a low carbohydrate/high unsaturated fatty acid diet on liver fat composition and gene expression in pre-diabetic individuals. All meals are provided under controlled conditions to maintain body weight while assessing dietary impact on hepatic health.See study design
What are the potential side effects?
As this is a dietary intervention focusing on macronutrient composition rather than medication or invasive procedures, significant side effects are not anticipated. However, changes in diet may cause digestive adjustments or discomfort.
DGENE-NAFLD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am generally healthy with normal kidney function and blood clotting.
Select...
I am between 18 and 60 years old.
DGENE-NAFLD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at day 3 and day 20 (at the end of the two 3-day diets)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at day 3 and day 20 (at the end of the two 3-day diets)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in the expression of key genes in hepatic fibrogenesis including transforming growth factor beta 1, a-smooth muscle actin, type-1 collagen, connective tissue growth factor
Change in the expression of key genes in lipid metabolism including LDL-receptor, acetyl-CoA acetyltransferase 2, apolipoprotein B, proproprotein convertase subtilisin/kexin type 9, microsomal triglyceride transfer protein
Change in the expression of key genes in liver inflammation including C-reactive protein, Interleukin-6, Interleukin-15, cell adhesion molecules, E-selectin
Secondary outcome measures
Change in liver's key lipid pathways (lipidomics) including lysophosphatidylcholine, phosphatidylcholine, diglyceride.
Identify bacteria strains involved in the control of blood glucose such as C elegans.
DGENE-NAFLD Trial Design
2Treatment groups
Experimental Treatment
Group I: Low fat dietExperimental Treatment2 Interventions
During 3 days, subjects eat a diet low in fat (percent of total caloric intake: 15.0% from proteins; 65.0% from carbohydrates; 20.0% from fat: 4.0% from saturated fat; 10.0% from monounsaturated fat; 6.0% from polyunsaturated fat
Group II: High fat dietExperimental Treatment2 Interventions
During 3 days, subjects eat a diet high in fat (percent of total caloric intake: 15.0% from proteins; 45.0% from carbohydrates; 40.0% from fat: 8.0% from saturated fat; 22.0% from monounsaturated fat; 10.0% from polyunsaturated fat
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Who is running the clinical trial?
Laval UniversityLead Sponsor
417 Previous Clinical Trials
172,266 Total Patients Enrolled
Patrick Couture, MD, PhDPrincipal InvestigatorLaval University
4 Previous Clinical Trials
124 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not diabetic and do not have uncontrolled metabolic diseases affecting my blood fats.I am generally healthy with normal kidney function and blood clotting.My kidney function is normal, without any significant disease.I do not have blood, digestive, brain or nerve disorders that could affect my participation.I am between 18 and 60 years old.Your blood has high levels of triglycerides (a type of fat) during the screening visit.I do not have heart or blood vessel disease, nor do I take medication that affects cholesterol.You have a history of serious mental health problems, drug or alcohol abuse in the past 2 years, or are currently being treated for a severe psychiatric illness that might make it hard for you to take part in the study.Your waist measurement is more than 102 cm (for men) or more than 88 cm (for women).Your blood sugar level is higher than 6.1 mmol/L after not eating for a while.Your insulin levels are too high when you haven't eaten for a while.I do not have severe inherited high cholesterol.You do not smoke cigarettes.If your blood takes longer than usual to clot, you cannot participate.
Research Study Groups:
This trial has the following groups:- Group 1: High fat diet
- Group 2: Low fat diet
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research endeavor allow individuals aged eighteen and above to participate?
"The inclusionary criteria for this trial stipulate that patients must be between 18 and 60 years of age."
Answered by AI
Are there still open spots available for the trial participants?
"According to clinicaltrials.gov, this medical trial is presently accepting patients. The original postdate was June 9th 2023 and the most recent update occurred on July 20th of the same year."
Answered by AI
Who has been determined to fulfill the criteria for this trial?
"Prerequisites for this medical trial involve having prediabetes and being between 18 and 60 years of age. There are currently 6 slots available for enrolment in the study."
Answered by AI
What is the total capacity of participants to this medical experiment?
"Affirmative. The particulars on clinicaltrials.gov suggest that the medical study is presently recruiting participants. This trial was initially advertised on June 9th 2023 and has been recently updated as of July 20th 2023, with plans to enrol 6 individuals at a single facility."
Answered by AI
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