Proteomics in Morbid Obesity After Bariatric Surgery (PROTOBESE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Geltrude Mingrone, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT01151917
First received: June 11, 2010
Last updated: January 29, 2014
Last verified: January 2014
  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 Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • Proteomics [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   25 Years to 55 Years
Genders 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
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: 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

No publications provided

Responsible Party: Geltrude Mingrone, professor, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01151917     History of Changes
Other Study ID Numbers: UCSC
Study First Received: June 11, 2010
Last Updated: January 29, 2014
Health Authority: Italy: Ethics Committee

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

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

ClinicalTrials.gov processed this record on October 23, 2014