Proteomics in Morbid Obesity After Bariatric Surgery (PROTOBESE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01151917
Recruitment Status : Completed
First Posted : June 29, 2010
Last Update Posted : January 30, 2014
Information provided by (Responsible Party):
Geltrude Mingrone, Catholic University of the Sacred Heart

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 mechanisms allowing restoration of insulin sensitivity after BPD the investigators aimed at identifying by using a proteomic approach plasma proteins or peptides that may be involved in the remarkably fast and explicit restoration of insulin sensitivity. In addition to the unbiased proteomics approach, a selection of recognized markers for metabolic control will be measured. These efforts all aim at an increased understanding of how insulin sensitivity is regulated and may provide novel ideas of how to treat insulin resistance and type 2-diabetes.

Condition or disease
Insulin Resistance Proteomics Morbid Obesity

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Identification of a Novel Factor(s) of Importance to Insulin Resistance -Repeated Blood Sampling Before and After Biliopancreatic Diversion
Study Start Date : June 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : July 2012

Bilio-pancreatic diversion
Each subject is own control

Primary Outcome Measures :
  1. Proteomics [ Time Frame: 2 years ]
    used to identify plasma proteins or peptides that may be involved in the remarkably fast and explicit restoration of insulin sensitivity seen in morbidly obese patients with insulin resistance shortly after gastric bypass surgery by BPD.

Secondary Outcome Measures :
  1. Insulin sensitivity and secretion and incretins [ Time Frame: 2 years ]
    Selection of recognized markers for metabolic control. Insulin secretion is measured by C-peptide deconvolution and insulin sensitivity by minimal modelling of glucose-insulin after a meal. Increatins will be measured too.

Biospecimen Retention:   Samples Without DNA
Serum and plasma samples at fasting and after a meal

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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Twenty male, morbidly obese subjects

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01151917

Day Hospital of Metabolic Diseases, Catholic University
Rome, Italy, 00168
Sponsors and Collaborators
Catholic University of the Sacred Heart
Principal Investigator: Geltrude Mingrone, Professor Catholic University of Rome

Responsible Party: Geltrude Mingrone, professor, Catholic University of the Sacred Heart Identifier: NCT01151917     History of Changes
Other Study ID Numbers: UCSC
First Posted: June 29, 2010    Key Record Dates
Last Update Posted: January 30, 2014
Last Verified: January 2014

Keywords provided by Geltrude Mingrone, Catholic University of the Sacred Heart:
Bilio-pancreatic diversion
morbid obesity
insulin resistance

Additional relevant MeSH terms:
Insulin Resistance
Obesity, Morbid
Nutrition Disorders
Body Weight
Signs and Symptoms
Glucose Metabolism Disorders
Metabolic Diseases