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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506300-12-00
Enrollment
24
Registered
2023-08-28
Start date
2023-12-18
Completion date
Unknown
Last updated
2025-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Non-alcoholic Fatty Liver Disease

Brief summary

Changes in VLDL-TG kinetics 8 months after treatment initiation, when their weight loss has stabilized: I) Changes in relation to the degree of weight loss. II) Changes in relation to the amount of fat in the liver, assessed by MRI-PDFF.

Detailed description

Changes between the groups in: I) Hepatic secretion of VLDL-TG particles, II) Glucose kinetics, III) Palmitate kinetics, IV) Circulating lipids, V) Insulin resistance, VI) Inflammatory markers, VII) Gut microbiota and metabolites, VIII) The Fibrosis-4 index (FIB-4), IX) NAFLD fibrosis score (NFS), X) Inflammatory markers in blood, gut, liver, fat, and muscle XI) Histology and gene expression in adipose tissue XII) Muscle mass and muscle structure and in histology and gene expression.

Interventions

Sponsors

Region Midtjylland
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Changes in VLDL-TG kinetics 8 months after treatment initiation, when their weight loss has stabilized: I) Changes in relation to the degree of weight loss. II) Changes in relation to the amount of fat in the liver, assessed by MRI-PDFF.

Secondary

MeasureTime frame
Changes between the groups in: I) Hepatic secretion of VLDL-TG particles, II) Glucose kinetics, III) Palmitate kinetics, IV) Circulating lipids, V) Insulin resistance, VI) Inflammatory markers, VII) Gut microbiota and metabolites, VIII) The Fibrosis-4 index (FIB-4), IX) NAFLD fibrosis score (NFS), X) Inflammatory markers in blood, gut, liver, fat, and muscle XI) Histology and gene expression in adipose tissue XII) Muscle mass and muscle structure and in histology and gene expression.

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026