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Effects of extensive Weight loss on Insulin resistance and Lipid-kinetics in people with obesity and fatty liver Disease
EU CTIS ID: 2023-506300-12-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. 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.
You likely can't join if
- 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®.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.