Status:
COMPLETED
Proteomics in Morbid Obesity After Bariatric Surgery
Lead Sponsor:
Catholic University of the Sacred Heart
Conditions:
Insulin Resistance
Proteomics
Eligibility:
MALE
25-55 years
Brief Summary
Glycemic control is rapidly restored in patients with insulin resistance after bariatric surgery, in particular after the mal-absorptive one (i.e. Bilio-pancreatic diversion, BPD). To evaluate the mec...
Detailed Description
Study design The study is designed as a single-centre, observational study. The patients will undergo routine analyses usually performed before and after biliopancreatic diversion surgery (BPD), indep...
Eligibility Criteria
Inclusion
- Morbidly obese male with a BMI \>40 kg/m2 who, for their obesity disease, are eligible for bariatric surgery and have accepted to undergo BPD
- Confirmed insulin resistance; fasting serum insulin level \> 60 pmol/L
- Age 25-55 years
- Weight stable for at least 6 months before the study (+/- 5 kg within the previous 6 months)
- Stable medication
- Provision of informed consent, statistical analysis, and publications of obtained results
Exclusion
- Patients not eligible for BPD
- Incapacity to give a valid informed consent or unwilling to give the consent
- Patients eligible for BPD, but with:
- Type 2-diabetes mellitus
- Significant illness within the two weeks preceding surgery, as judged by the physician.
- Obvious infection (bacteria, virus etc)
- Major cardiovascular disease
- Major gastrointestinal, respiratory, or any hormonal disorders
- Medication affecting lipid metabolism within 3 months of the study
- History of drug addiction and/or alcohol use
- Suspected or confirmed poor compliance
- Exercise +/-3 times a week
- Blood donation within 12 weeks preceding screening visit
Key Trial Info
Start Date :
June 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01151917
Start Date
June 1 2009
End Date
July 1 2012
Last Update
January 30 2014
Active Locations (1)
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1
Day Hospital of Metabolic Diseases, Catholic University
Rome, Italy, 00168