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CompletedNCT05044130Updated Mar 21, 2024

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

An interventional study of High-fat mixed-meal tolerance test (HF-MMTT) in NAFLD and Type 2 Diabetes, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-03-21.

Sponsored by University of Aarhus · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
17
Allocation
Non-randomized
Ages
30 Years to 70 Years
Sex
All
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Study summary

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.

02

Conditions studied

03

In context

Non-alcoholic Fatty Liver Disease

1,474 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 303 are open to participants now.

This study's enrollment of 17 is below the median of 60 across 1,072 interventional studies indexed under Non-alcoholic Fatty Liver Disease.

Browse Non-alcoholic Fatty Liver Disease studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subjects with Type 2 Diabetes with and without NAFLD (steatosis FF% > 5,6% on MR spectroscopy for NAFLD and NASH groups)

Exclusion criteria

Exclusion Criteria:

  • Active smoking
  • Comorbidity other than hypertension and hyperlipidemia
  • Fixed medical drug consumption (including insulin) except statins and anti-diabetic medications. However, statins must be paused 2 weeks before the examination date and other antidiabetic medication on examination date.
  • Patients with cancer or former cancer patients
  • Blood donation within the last 3 months prior to the study
  • Participation in experiments involving radioactive isotopes within the last 3 months
  • Alcohol abuse (over 21 items per week for men and over 14 for women)
  • Pregnancy
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Active comparator
    Type 2 Diabetes with NAFLD

    Patients with Type 2 Diabetes with NAFLD MR spectroscopy verified steatosis

    Dietary Supplement: High-fat mixed-meal tolerance test (HF-MMTT)

  • Active comparator
    Type 2 Diabetes without NAFLD

    Patients with Type 2 Diabetes without NAFLD MR spectroscopy verified no steatosis

    Dietary Supplement: High-fat mixed-meal tolerance test (HF-MMTT)

Interventions

  • Dietary supplementHigh-fat mixed-meal tolerance test (HF-MMTT)

    The test meal consists of a standardized HF-MMTT (791 cal) with 197 g cream (38 % fat), 18 g sugar and 1 g vanilla sugar for taste (75 g fat, 25 g carbohydrate and 4 g protein)

06

What researchers measure

Primary outcomes

  1. VLDL-triglyceride secretion - Ex vivo labeled VLDL - [14C]-triolein tracer technique.

    (μmol/min)

    Time frame: 1 day

  2. VLDL-triglyceride uptake in muscle - Measurement of fatty acid concentration and specific activity in muscle biopsies

    (percent)

    Time frame: 1 day

  3. VLDL-triglyceride uptake in adipose tissue - Measurement of fatty acid concentration and specific activity in adipose tissue biopsies

    (percent)

    Time frame: 1 day

Secondary outcomes

  1. VLDL-triglyceride oxidation - Oxidation is measured by specific activity in exhaled air.

    (μmol/min)

    Time frame: 1 day

  2. Adipose cell size measurement

    (μl)

    Time frame: 1 day

  3. Insulin sensitivity

    (mg/kg/min)

    Time frame: 1 day

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Study locations

1 site
  • Department of Endocrinology and Internal Medicine
    Aarhus N, 8200, Denmark
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05044130
Lead sponsor
University of Aarhus
Collaborators
Danish Diabetes Academy
Responsible party
Sponsor
First posted
Sep 14, 2021
Start date
Sep 14, 2021
Primary completion
Feb 23, 2023
Completion
Apr 23, 2023
Last update
Mar 21, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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