Effects of extensive Weight loss on Insulin resistance and Lipid-kinetics in people with obesity and fatty liver Disease
Key facts
- Where
- Aarhus N, DániaSee the site
- Phase
- 4. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Dánia
- Region MidtjyllandAarhus N, DániaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Region Midtjylland
- Trial code
- EU 2023-506300-12-00
- Record updated
- 2025. április 25.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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®.