Proteomics in Morbid Obesity After Bariatric Surgery

NCT01151917 | Completed

• 1 other identifier: UCSC
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulin Resistance; Proteomics; Morbid Obesity

Keywords

Bilio-pancreatic diversion; morbid obesity; insulin resistance; proteomics

Outcome Measures

Primary Outcomes (1)

• Proteomics

  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.

  2 years

Secondary Outcomes (1)

• Insulin sensitivity and secretion and incretins

  2 years

Study Arms (1)

Bilio-pancreatic diversion

Each subject is own control

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Twenty male, morbidly obese subjects

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Day Hospital of Metabolic Diseases, Catholic University

Rome, 00168, Italy

Location

Related Publications (1)

• Karlsson C, Wallenius K, Walentinsson A, Greasley PJ, Miliotis T, Hammar M, Iaconelli A, Tapani S, Raffaelli M, Mingrone G, Carlsson B. Identification of Proteins Associated with the Early Restoration of Insulin Sensitivity After Biliopancreatic Diversion. J Clin Endocrinol Metab. 2020 Nov 1;105(11):e4157-68. doi: 10.1210/clinem/dgaa558.

  PMID: 32830851 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma samples at fasting and after a meal

MeSH Terms

Conditions

Insulin Resistance; Obesity, Morbid

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Geltrude Mingrone, Professor

  Catholic University of Rome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 11, 2010
• First Posted: June 29, 2010
• Study Start: June 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: July 1, 2012
• Last Updated: January 30, 2014

Record last verified: 2014-01

Locations

IT (1)