ObesityNCT01489657
The Metabolite Profiling of Obese Subjects Before and After Sleeve Gastrectomy
An observational study of Obesity, run by Wolfson Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2011to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The Bariatric Surgery Clinics
Who may be able to join
- BMI > 30
- Willing to undergo sleeve gastrectomy
Who cannot join
- Inability to sign the informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Sleeve Gastrectomy Surgery in Obese Subjects on Metabolite Profiling
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.
Read the 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.
- Conditions
- Obesity
- Keywords
- Obesity, Bariatric Surgery, Sleeve Gastrectomy, Metabolite Profiling
- Medical subject headings
- Obesity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2012
- Study completionJun 2016
Why it stopped: The results were not significant, therfore the study ended prematurily
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, zohar landau, Wolfson Medical Center
- Investigators
- Zohar Landau, MD, Principal investigator, Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01489657
- Sponsor's protocol ID
- METPAR1
- Status last verified
- Jun 2016
- First submitted
- 8 Dec 2011
- Last updated
- 8 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Sleeve Gastrectomy Surgery in Obese Subjects on Metabolite Profiling
- ClinicalTrials.gov ID
- NCT01489657
- Acronym / sponsor ID
- METPAR1
- Conditions
- Obesity
- Keywords
- Obesity, Bariatric Surgery, Sleeve Gastrectomy, Metabolite Profiling
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The results were not significant, therfore the study ended prematurily
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- Jul 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 9 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The Bariatric Surgery Clinics
Key inclusion criteria (2 listed)
- BMI > 30
- Willing to undergo sleeve gastrectomy
Key exclusion criteria (1 listed)
- Inability to sign the informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zohar Landau, MD principal investigator
Wolfson Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Wolfson Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2016.