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Proteomics in Morbid Obesity After Bariatric Surgery (PROTOBESE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01151917
First Posted: June 29, 2010
Last Update Posted: January 30, 2014
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.
Information provided by (Responsible Party):
Geltrude Mingrone, Catholic University of the Sacred Heart
  Purpose
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
Insulin Resistance Proteomics Morbid Obesity

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Geltrude Mingrone, Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • 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:
  • 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

Enrollment: 20
Study Start Date: June 2009
Study Completion Date: July 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Bilio-pancreatic diversion
Each subject is own control

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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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
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01151917


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

Responsible Party: Geltrude Mingrone, professor, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01151917     History of Changes
Other Study ID Numbers: UCSC
First Submitted: June 11, 2010
First Posted: June 29, 2010
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
proteomics

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