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2023-506300-12-00CompletedPhase 4

Effects of extensive Weight loss on Insulin resistance and Lipid-kinetics in people with obesity and fatty liver Disease

Source: EU CTIS (euclinicaltrials.eu) · Last updated 25 Apr 2025

Next steps

Brief summary (registry, in English)

We aim to investigate the changes in very low-density lipoproteins- and triglycerides (VLDL-TG) kinetics before, during, and after extensive weight loss in women diagnosed with both obesity and non-alcoholic fatty liver disease.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
24 (actual)
First submitted
13 Jun 2023
Start date
18 Dec 2023
Lead sponsor
Region Midtjylland
EU CT number
2023-506300-12-00

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 24
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Lab values

  • 1., Treatment with GLP-1ra within the last 6 months., 2. Type 1 diabetes or type 2 diabetes (fasting blood sugar over 7 mmol/L, non-fasting blood sugar over 11.1 mmol/L. or HbA1c >48). , 3. Alcohol consumption of more than 20 g/day, equivalent to approximately 1.5 standard drinks daily., 4. Known liver disease other than MASLD., 5. Known polycystic ovary syndrome., 6. Other uncontrolled medical condition (e.g., thyroid disease) assessed by the investigators., 7. Kidney disease GFR < 30 mL/min/1,73 m2., 8. Weight above 170 kg, shoulder width measured at the widest point above 65 cm, or circumference above 160 cm measured at the participant's widest point (as they would not be able to undergo MRS/MRI-PDFF and RYGB without prior weight loss). 9., Recent weight loss or weight gain exceeding 5% of body weight. 10., Contraindication to RYGB (Roux-en-Y gastric bypass)., 11. Pregnancy or women not using reliable contraception., 12. Liver cirrhosis, either known or suspected based clinical and/or biochemical parameters., 13. Allergy to ingredients in Wegovy®.

Who the study is looking for

  • Women who meet the Danish health authorities' criteria for being offered surgical treatment of severe obesity, which are: (i) Body mass index (BMI) over 35 and at least one of the following comorbidities: osteoarthritis in the lower extremities, documented sleep apnea, or severe uncontrolled hypertension, or (ii) extreme obesity with BMI over 50., 2. Age above 18., 3. Understands and speaks Danish., 4. Either MRS/MRI-PDFF with more than 5% steatosis in the liver or a CAP greater than 280 dB/m.

Age in the registry: 18 years to 64 years · Sex: Female · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Region MidtjyllandAarhus NDenmarkCompleted

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This page is information, not medical advice. Discuss any trial with your doctor.