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RecruitingNCT01477957

The Effect of Bariatric Surgery on Insulin Sensitivity and Energy Metabolism

The Effect of Bariatric Surgery on Insulin Sensitivity and Energy Metabolism in Obesity Grade 2 -3

Status
Recruiting
Phase
Study type
Observational
Enrollment
450 (estimated)
Sponsor
German Diabetes Center · Academic / Other
Sex
All
Age
20 Years – 70 Years
Healthy volunteers
Accepted

Summary

The purpose of this study is: 1. To explore to what extent insulin sensitivity, energy metabolism and ectopic lipid storage can be improved by bariatric surgery 2. To explore to what extent hepatic and muscular disorders of energy metabolism occur in patients with obesity (degree 2-3) 3. To explore whether the steato liver occurring in patients with obesity (degree 2-3) is associated with the degree of liver inflammation

Detailed description

Insulin resistance strongly relates to ectopic lipid deposition in skeletal muscle and the liver, which correlate with insulin resistance. Lipid metabolites accumulating in skeletal muscle and the liver are thought to impair insulin signalling and thereby reduce glucose uptake and glycogen storage. Insulin resistant humans frequently present with decreased mitochondrial function in skeletal muscle which might contribute to lipid accumulation and the development of insulin resistance. Metabolic dysfunction-associated steatotic liver disease comprises steatosis, steatohepatitis and cirrhosis. MASLD correlates with insulin resistance, increased risk for cardiovascular diseases and type 2 diabetes. The mechanisms leading from steatosis to steatohepatitis and insulin resistance in the liver are yet unclear. Bariatric surgery aims at profound reduction of body weight. Also, it frequently and rapidly leads to normalization of glucose tolerance even before the onset of body weight reduction. The underlying mechanisms are yet unclear. In this study we aim to explore the mechanisms underlying the onset of insulin resistance and steatohepatitis in patients with steatosis and to identify the mechanisms leading to improved glucose tolerance in humans after bariatric surgery. We test the following hypotheses: increased lipid availability leads to (i) increased lipid oxidation and oxidative stress (ii) accumulation of lipid metabolites that impair insulin signalling (iii) bariatric surgery improves insulin sensitivity by increasing lipid oxidation. This study will contribute to the understanding of MASLD and will help to identify new targets for the therapy of diabetes.

Conditions

Interventions

TypeNameDescription
PROCEDUREsurgerybiliopancreatic diversion, gastric banding, gastric sleeve resection

Timeline

Start date
2012-09-01
Primary completion
2028-12-01
Completion
2028-12-01
First posted
2011-11-23
Last updated
2025-01-10

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT01477957. Inclusion in this directory is not an endorsement.