Obesity Clinical Trial - The Effect of Bariatric Surgery on Insulin

Status Recruiting

Clinical Trial 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

Clinical Trial 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. Non-alcoholic liver disease (NAFLD) comprise fatty liver, steatohepatitis and cirrhosis. NAFLD correlate with insulin resistance increased risk for cardiovascular diseases, type 2 diabetes and hepatocellular. The mechanisms leading from fatty liver to steatohepatitis and insulin resistance in the liver are yet unclear. Bariatric surgery relates to surgery for the reduction of body weight. Bariatric surgery frequently leads to normalization of glucose tolerance in previously diabetic humans 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 fatty liver 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 NAFLD and will help to identify new targets for the therapy of diabetes. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01477957
Study type	Observational
Source	German Diabetes Center
Contact	Sabine Kahl, MD
Phone	0049211-3382
Email	sabine.kahl@ddz.de
Status	Recruiting
Phase
Start date	September 2012
Completion date	December 2028

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

The Effect of Bariatric Surgery on Insulin Sensitivity and Energy Metabolism — BARIA-DDZ

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms