NCT05044130

Postprandial VLDL-triglyceride Metabolism in Type 2 Diabetes Patients With and Without NAFLD

Completed NA Last updated 21 March 2024

What this trial tests

NA trial testing High-fat mixed-meal tolerance test (HF-MMTT) in NAFLD in 17 participants. Completed in 23 April 2023.

Timeline

14 September 2021

Primary endpoint
23 February 2023

23 April 2023

Quick facts

Lead sponsor	University of Aarhus
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	17
Start date	14 September 2021
Primary completion	23 February 2023
Estimated completion	23 April 2023
Sites	1 location across Denmark

Drugs / interventions tested

• High-fat mixed-meal tolerance test (HF-MMTT)

Conditions studied

• NAFLD — all drugs for NAFLD →
• Type 2 Diabetes — all drugs for Type 2 Diabetes →

Sponsor

University of Aarhus

Who can join

Adults 30 to 70, any sex, with NAFLD or Type 2 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Non-alcoholic fatty liver disease (NAFLD) covers a spectrum from simple reversible hepatic steatosis to inflammation and fibrosis termed steatohepatitis (NASH). The mechanisms behind why some subjects progress from NAFLD to NASH are not clear and the responsible mechanism for storage of excess amounts of liver fat in patients with NAFLD are poorly understood.

Patients with type 2 diabetes mellitus (T2D) and abdominally obese subjects very often have accumulation of liver fat (NAFLD).

T2D is also associated with abnormal lipid metabolism (dyslipidemia), including free fatty acids (FFA), hypertriglyceridemia and excessive postprandial hyperlipidemia which increases the risk of ischemic cardiovascular disease (CVD) and heart failure.

In healthy, insulin sensitive subjects the postprandial increase in triglycerides (TG) is primarily caused by meal derived chylomicrons, whereas endogenously produced TG (VLDL-TG) and decreased peripheral TG clearance only becomes quantitatively important in insulin resistant subjects .Thus, postprandial lipidemia in T2D results from both chylomicronemia as well as a reduction in both insulin mediated suppression of VLDL-TG secretion and lipoprotein lipase (LPL) mediated peripheral clearance. A recent study demonstrated that the ability of insulin to suppress hepatic VLDL-TG after a fat-enriched meal and the duration of the postprandial hyperlipidemia was similar in patients with T2D compared with age- and BMI matched individuals without T2D, indicating that the degree of insulin mediated VLDL-TG secretion and hyperlipidemia primarily depends on insulin sensitivity and not the presence of T2D diabetes per se.

In these studies, the investigators want to examine the effect of a fat enriched mixed-meal on hepatic VLDL-TG handling and adipose storage capacity in patients with T2D with and without NAFLD. Investigators will address these questions using carboxyl-14C triolein labeled VLDL-TG, magnetic resonance (MR) spectroscopy of liver, muscle and fat biopsies in combination with state-of-the art muscle and adipose tissue enzyme kinetics, gene- and protein expression.

The overarching goals are to define abnormalities and differences between patients with T2D with and without NAFLD in terms of hepatic lipid metabolism.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.