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临床试验/CTIS2023-506300-12-00
CTIS2023-506300-12-00招募中1 期

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

Region Midtjylland0 个研究点目标入组 24 人开始时间: 2023年6月13日最近更新:
适应症

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
24

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 64(—)

入选标准

  • 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.

排除标准

  • 1., Treatment with GLP-1ra within the last 6 months., 2. Type 1 diabetes or type 2 diabetes, i.e., fasting blood sugar over 7 mmol/L or non-fasting blood sugar over 11.1 mmol/L. , 3. Alcohol consumption of more than 20 g/day, equivalent to approximately 1.5 standard drinks daily., 4. Known liver disease other than NALFD., 5. Known polycystic ovary syndrome., 6. Other uncontrolled medical condition (e.g., thyroid disease, kidney disease) assessed by the investigators., 7. 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). 8., Recent weight loss or weight gain exceeding 5% of body weight. 9., Contraindication to RYGB (Roux-en-Y gastric bypass)., 10. Pregnancy or women not using reliable contraception., 11. Liver cirrhosis, either known or assessed based on Fibroscan > 14 kPa., 12. Allergy to ingredients in Wegovy®.

研究者

发起方
Region Midtjylland

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