Insulin ResistancePROTOBESENCT01151917
Proteomics in Morbid Obesity After Bariatric Surgery
An observational study of Insulin Resistance and Proteomics, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 25 to 55 years, men only
- Conditions the study is for
- Insulin Resistance, Proteomics, Morbid Obesity
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2009to Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- Men only
- No healthy volunteers
- Adult
Study population: Twenty male, morbidly obese subjects
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of a Novel Factor(s) of Importance to Insulin Resistance -Repeated Blood Sampling Before and After Biliopancreatic Diversion
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.
Read the 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), independently of the participation to this specific protocol with the only exception of meal test. Twenty morbidly obese male subjects scheduled for BPD for will be included in the study.
The inclusion and exclusion criteria are set as to create a sufficiently homogenous study population.
As outlined in the study flow chart subjects will be studied and blood samples collected at 3 weeks (+/- 1 week) and 4 days (+/- 1 day) before the day of BPD surgery (baseline-1 and baseline-2), at the day of surgery (day 0), every second day after surgery during the first week (immediate post surgery) as well as two and four weeks after surgery (post surgery-1 and post surgery-2). A deviation of +/- 2 days is allowed for the post surgery-1 and post surgery-2 visits.
All fasting samples are obtained in the morning after an overnight fast (12 h). Immediate post surgery (fasting) samples will be collected after 12 h rest from parenteral nutrition from the arm not used for nutritional substitution during the first 4 days after surgery (when parenteral nutrition is given). The immediate post surgery (fasting) samples obtained from day 5 and forward after surgery, when subjects have started to eat, will be obtained in the morning after an overnight fast (12 h). Nutrient stimulation samples will be obtained at baseline-1 and 2 and post surgery-1 and 2 after intake of a test meal. A complete list of all procedures for each visit is provided in Table 1 and an overview of all planned blood samples, including volumes and purpose is provided in Table 2. Motivations for the collection of various samples are provided under section 10.3.1 "Proteomics analysis, experimental design issues".
In case of discontinuation, additional subjects should be enrolled such that a complete set of samples from no less than 20 subjects can be obtained.
Target subject population 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
- Conditions
- Insulin Resistance, Proteomics, Morbid Obesity
- Keywords
- Bilio-pancreatic diversion, morbid obesity, insulin resistance, proteomics
- Medical subject headings
- Insulin Resistance, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bilio-pancreatic diversion | Each subject is own control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
Insulin sensitivity and secretion and incretins
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startJun 2009
- Primary completionJan 2011
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geltrude Mingrone, Catholic University of the Sacred Heart
- Investigators
- Geltrude Mingrone, Professor, Principal investigator, Catholic University of Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01151917
- Sponsor's protocol ID
- UCSC
- Acronym
- PROTOBESE
- Status last verified
- Jan 2014
- First submitted
- 11 Jun 2010
- Last updated
- 30 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32830851
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of a Novel Factor(s) of Importance to Insulin Resistance -Repeated Blood Sampling Before and After Biliopancreatic Diversion
- ClinicalTrials.gov ID
- NCT01151917
- Acronym / sponsor ID
- PROTOBESE / UCSC
- Conditions
- Insulin Resistance, Proteomics, Morbid Obesity
- Keywords
- Bilio-pancreatic diversion, morbid obesity, insulin resistance, proteomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 29 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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), independently of the participation to this specific protocol with the only exception of meal test. Twenty morbidly obese male subjects scheduled for BPD for will be included in the study.
The inclusion and exclusion criteria are set as to create a sufficiently homogenous study population.
As outlined in the study flow chart subjects will be studied and blood samples collected at 3 weeks (+/- 1 week) and 4 days (+/- 1 day) before the day of BPD surgery (baseline-1 and baseline-2), at the day of surgery (day 0), every second day after surgery during the first week (immediate post surgery) as well as two and four weeks after surgery (post surgery-1 and post surgery-2). A deviation of +/- 2 days is allowed for the post surgery-1 and post surgery-2 visits.
All fasting samples are obtained in the morning after an overnight fast (12 h). Immediate post surgery (fasting) samples will be collected after 12 h rest from parenteral nutrition from the arm not used for nutritional substitution during the first 4 days after surgery (when parenteral nutrition is given). The immediate post surgery (fasting) samples obtained from day 5 and forward after surgery, when subjects have started to eat, will be obtained in the morning after an overnight fast (12 h). Nutrient stimulation samples will be obtained at baseline-1 and 2 and post surgery-1 and 2 after intake of a test meal. A complete list of all procedures for each visit is provided in Table 1 and an overview of all planned blood samples, including volumes and purpose is provided in Table 2. Motivations for the collection of various samples are provided under section 10.3.1 "Proteomics analysis, experimental design issues".
In case of discontinuation, additional subjects should be enrolled such that a complete set of samples from no less than 20 subjects can be obtained.
Target subject population 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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bilio-pancreatic diversion | – | –Each subject is own control |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Twenty male, morbidly obese subjects
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- Patients not eligible for BPD
- Incapacity to give a valid informed consent or unwilling to give the consent
- Patients eligible for BPD, but with:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Insulin sensitivity and secretion and incretins
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2014.
- Derived from this study: PubMed 32830851Karlsson 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.
Related trials for Insulin Resistance
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geltrude Mingrone, Professor principal investigator
Catholic University of Rome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insulin Resistance and Proteomics, run by Catholic University of the Sacred Heart at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proteomics (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01151917, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2014.