An interventional study of RYGB and GLP-1 in Glucose Metabolism Disorders, Obesity and Degenerative Brain Disorder, sponsored by University of Pisa. Completed at 1 site in Italy. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-07-19.
Sponsored by University of Pisa · Not applicable, Interventional, and Treatment
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Among 20 studies in Glucose Metabolism Disorders with a site in Italy — 2 open to participants now, 2 under way, 1 of them phase 3. Glucose Metabolism Disorders · Italy.
Among the 20 studies in Glucose Metabolism Disorders with a site in Italy, this one is the 16th largest by enrollment of the 17 interventional ones that give a count, is one of 2 that started in 2016, is one of 8 with no phase, and was the 7th registered.
361 studies on the registry are indexed under Glucose Metabolism Disorders; 38 are open to participants now.
Browse Glucose Metabolism Disorders studies →2 of the 20 studies in Glucose Metabolism Disorders with a site in Italy are open now. Recruiting first, the newest first:
Pfizer · Sites in Italy, United States, Brazil and 8 more countries
Ages 18+
Ultragenyx Pharmaceutical Inc · Sites in Italy, United States, Brazil and 6 more countries
Ages 2+
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 29 Glucose Metabolism Disorders studies recruiting now, 9 (31%) set no upper age limit and 18 (62%) stop at 75 or younger; 7 take children under 18; 11 take healthy volunteers.
This study: 18 Years to 60 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
20 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 2 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 14 is below the median of 60 across 308 interventional studies indexed under Glucose Metabolism Disorders.
Median enrollment 55 across the 17 interventional studies, 140 across the 3 observational. Of the 13 that completed or were terminated, 4 (31%) have results posted.
This tab as a report to print or save as PDF → With an account.
9 of 20 have an industry lead sponsor. The 10 most frequent:
University of Pisa is the lead sponsor of 113 studies on the registry; 28 are open to participants now.
University of Pisa has 2 studies filed under Glucose Metabolism Disorders — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 20 studies in Glucose Metabolism Disorders with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
To test the hypothesis that GLP1 can exert favourable effects on multiple aspects of brain function. To this purpose, the investigator determine whether chronic increase in GLP1 concentration as it occurs after bariatric surgery (Roux-en- Y Gastric Bypass) is associated with improvement in:
The research project will include two separate studies:
Morbid Obese Subjects Group:
This study will consist in a single arm, non randomized, uncontrolled, single center before-and after RYGB in 15 morbid obese subjects.
Healthy Subjects Group:
This study will consist in a single arm, non randomized, uncontrolled, single center study in 8 healthy subjects.
The primary endpoint are the changes in:
Morbid obese subjects participating in this study will be evaluated before and 6 months after bariatric surgery which is routinely performed to treat morbid obesity. For the purpose of baseline assessment subjects will undergo 3 visits at 1 week interval. All test procedures will be repeated in two subsequent visits 6 months after surgery with body weight being stable. Therefore, participation in the study will require a total of 5 visit with a post-trial phone contact 2 weeks after completion for safety assessment.
Healthy subjects will be recruited for determining the acute effect of GLP1 on brain function irrespective of changes in the metabolic milieu. The study will require participation in a total of 3 visits.
Inclusion Criteria:(Morbid Obese Subjects Group)
Inclusion Criteria (Healthy Subjects Group)
Exclusion Criteria:(both groups)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Roux-en- Y gastric bypass (RYGB) is the most popular bariatric procedure and it has been associated with improvements in glycemic control and cognitive function. It works by decreasing the amount of food you can eat at one sitting and by changing the hormones released at the bottom of the stomach and duodenum.we propose that RYGB is a model of chronic elevation of GLP-1 providing an opportunity to explore relationship between changes in the circulating hormone and brain glucose metabolism, cognitive function and neuroplasticity.
Procedure: RYGB
GLP-1 is an intestinal hormone secreted in response to nutrients.
Drug: GLP-1
RYGB is associated with a increase of circulating GLP-1 (up to ten-fold) especially in response to meal ingestion. This increased availability of GLP1 has been claimed to contribute to restoration of some of the beta-cell function.
GLP-1 is an hormone secreted by gut in response to nutrients ingestion.
Also known as: gut hormone
sustained Weight Loss
normalizing obesity-related comorbidities.
Time frame: 6 months
glycemic Control
GLP-1 level controled
Time frame: 6 months
cognitive Function
cognitive function measured by Mini Mental State Examination (MMSE).
Time frame: 6 months
Ran from Jun 2016 to primary completion in Jun 2017, 12 months.
Of 106 non-industry interventional studies with no phase under Glucose Metabolism Disorders, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 40. This study's 12 months is below that.
Counting every sponsor, half of 119 studies reached it within 19 months; a quarter within 7 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Glucose Metabolism Disorders →