The Metabolite Profiling of Obese Subjects Before and After Sleeve Gastrectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Wolfson Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
zohar landau, Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT01489657
First received: December 8, 2011
Last updated: NA
Last verified: December 2011
History: No changes posted
  Purpose

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.


Condition
Obesity

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Impact of Sleeve Gastrectomy Surgery in Obese Subjects on Metabolite Profiling

Resource links provided by NLM:


Further study details as provided by Wolfson Medical Center:

Biospecimen Retention:   Samples Without DNA

Serum


Estimated Enrollment: 30
Study Start Date: July 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The Bariatric Surgery Clinics

Criteria

Inclusion Criteria:

  • BMI > 30
  • Willing to undergo sleeve gastrectomy

Exclusion Criteria:

  • Inability to sign the informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01489657

Locations
Israel
Wolfson Medical Center, Bariatric Surgery Clinic Recruiting
Holon, Israel, 58100
Contact: Zohar Landau, MD    97235028420      
Principal Investigator: Zohar Landau, MD         
Sponsors and Collaborators
Wolfson Medical Center
Investigators
Principal Investigator: Zohar Landau, MD Wolfson Medical Center
  More Information

No publications provided

Responsible Party: zohar landau, Head of Pediatric Endocrinology Service, Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT01489657     History of Changes
Other Study ID Numbers: METPAR1
Study First Received: December 8, 2011
Last Updated: December 8, 2011
Health Authority: Israel: Ethics Commission

Keywords provided by Wolfson Medical Center:
Obesity
Bariatric Surgery
Sleeve Gastrectomy
Metabolite Profiling

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 19, 2014