The Metabolite Profiling of Obese Subjects Before and After Sleeve Gastrectomy

Obesity Clinical Trial

Official title:

The Impact of Sleeve Gastrectomy Surgery in Obese Subjects on Metabolite Profiling

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01489657
• Other study ID #: METPAR1
• Status: Withdrawn
• Phase: N/A
• First received: December 8, 2011
• Last updated: June 7, 2016
• Start date: July 2011
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Wolfson Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial Summary

The purpose of this prospective observational study is to generate further insight into the numerous metabolic adaptations associated with sleeve gastrectomy surgery in obese subjects by profiled serum metabolites before and after the surgery and integrated metabolite changes with clinical data.

Description:

In the present study we examine the metabolic fluctuations of the most important amino acids and fatty acids to better understand the metabolic process in weight reduction in obese subjects that underwent sleeve gastrectomy surgery.

The availability of the tandem equipment for amino acids and fatty acids determinations for the medical system gives us an opportunity to investigate the metabolic turmoil of weight reduction seen in obese subjects after sleeve gastrectomy.

We evaluated the lipid metabolism by the measurements of the fraction of carnitine fatty acids which is the most available one because only a small blood specimen from a finger puncture is needed.

In the present study we measured the blood concentrations of monocarboxylic and dicarboxylic fatty acids bounded to carnitine, free carnitine and also free amino acids 2 weeks before the surgery while subjects eat their regular high caloric diet, one week, one month and 3 month after the procedure.

Carnitne fatty acids comprise only the tip of the iceberg of all circulating fatty acids in the blood with a roughly distribution of: triglycerides, phospholipids and cholesteryl fatty acids 4 (Lipids43-65), free fatty acids 0.6, and carnitne fatty acids 0.005 mM. Some additional amount is also circulating in lipoproteins. Even carnitine monocarboxylic fatty acids comprise around 1% of the free fatty acids and around 0.1% of all fatty compounds, the fluctuations in their concentrations probably reflect the most dynamics metabolic events because fatty acid oxidation must initiate by binding fatty acid to carnitine. The concentration of dicarboxylic carnitine fatty acids is much higher and comprises about 2% for malic carnitine and about 10% for glutaric carnitine in the total amount of free acids (http://www.hmdb.ca/). Yet, as for monocarboxylic fatty acids, a remarkable mass of dicarboxylic acids is still present as free acids.

For all carnitne acyl compounds the distribution forms have a high variability on different physiological conditions.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2016
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• BMI > 30

• Willing to undergo sleeve gastrectomy

Exclusion Criteria:

• Inability to sign the informed consent

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Obesity

Locations

Country	Name	City	State
Israel	Wolfson Medical Center, Bariatric Surgery Clinic	Holon

Sponsors (1)

Lead Sponsor	Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel,