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Glucose Metabolism DisordersNCT03414333

To Determine the Effect of GLP1 on Cognitive Function, Brain Glucose Metabolism and Neuroplasticity.

A study testing RYGB and GLP-1 in people with Glucose Metabolism Disorders and Obesity, run by University of Pisa at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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: cognitive function measured… Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
RYGB and GLP-1
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteItaly
Study dates
29 Jun 2016to Jun 2018
Phase
Interventional
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 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Males and females undergoing bariatric surgery as per clinical management
  • Age = 18-60 years
  • BMI>35 Kg/m 2 and stable weight (± 3 lbs) over the preceding three months
  • Normal Glucose Tolerance (HbA1c > 4.5 % and < 5.7%) or Type 2 diabetes (HbA1c >5.7 % and <10.0%)
  • Stable eGFR (>60 ml/min/1.73 m2 )
  • Drug naive for type 2 diabetes treatment or on stable dose more than 3 months with anti-diabetic agents other than DPP4-inhibitors, GLP1 receptor agonists, and insulin.
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  • Subjects are capable of giving informed consent
  • Males and females
  • Age = 18-60 years
  • BMI 22-35 Kg/m 2 and stable weight (± 3 lbs) over the preceding three months
  • Stable eGFR (\&gt;60 ml/min/1.73 m 2 )
  • Normal Glucose Tolerance (HbA1c>4.5 % and< 5.7%)
  • Subjects are capable of giving informed consent.

Who cannot join

  • Steroids treatment
  • Psychiatric Disorders
  • Mental Retardation
  • Severe cognitive Impairment
  • Neurodegenerative diseases
  • Epilepsy
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  • Depression Treatment
  • Traumatic Brain Injury over the preceding six months
  • Liver function enzymes higher more than two times the upper limit
  • Heart Failure (NYHA III-IV)
  • Type 1 Diabetes
  • Diabetic Ketoacidosis
  • GFR<60 ml/min/1.73 m 2
  • Donation of blood to a blood bank, blood transfusion, or participation in a clinical study requiring withdrawal of \&gt; 400 mL of blood during the 8 weeks prior to the enrollment visit and at least 8 weeks thereafter
  • Women who are pregnant or breastfeeding
  • Patient with a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance which, in the opinion of the investigator or coordinator, might pose an unacceptable risk to the patient or interfere with trial procedures.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Dept.Clinical and Experimental Medicine.Section of Diabetes.

    Pisa

Other trials in Italy

About this study

Official title: The Effect of Glucagon-like Peptide-1 (GLP-1) on Cognitive and Non-cognitive Function in Human

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:

  • cognitive function measured by Mini Mental State Examination (MMSE) and Mental Deterioration Battery(MDB).
  • brain glucose metabolism measured by FDG-CT/PET
  • neuroplasticity measure by binocular rivalry and saccadic adaptation tests in morbid obese subjects. In order to discern the effect of GLP1 irrespective of changes in the metabolic milieu the investigator will test whether short-term GLP-1 infusion can modulate the same parameters in healthy subjects.
Read the detailed description

The research project will include two separate studies:

  1. In obese subjects undergoing RYGB to test the effect of chronic elevation of GLP1 levels, and
  2. In normal volunteers to test the acute effect of GLP1, irrespective of changes in the metabolic milieu In several aspects of brain function as detailed below:.

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:

  • cognitive function measured by Mini Mental State Examination (MMSE) and Mental Deterioration Battery (MDB)
  • brain glucose metabolism measured by FDG-CT/PET
  • neuroplasticity measure by binocular rivalry and saccadic adaptation tests six months after RYGB in morbid obese subjects and with elevation of circulating GLP1 levels in healthy subjects.

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.

Being tested
RYGB, GLP-1
Keywords
obesity, cognitive dysfunction
Medical subject headings
Glucose Metabolism Disorders, Obesity, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RYGBProcedure or surgery

    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-1Drug

    Also called gut hormone

    GLP-1 is an hormone secreted by gut in response to nutrients ingestion.

Study groups in NCT03414333
Study groupRoleWhat they receive
Roux-en- Y gastric bypass (RYGB)ExperimentalRoux-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.
Receives: Procedure: RYGB
GLP-1Active comparatorGLP-1 is an intestinal hormone secreted in response to nutrients.
Receives: Drug: GLP-1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. sustained Weight Loss

    normalizing obesity-related comorbidities.

    Measured: 6 months

Secondary outcomes (1)

  1. glycemic Control

    GLP-1 level controled

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2018
  2. Study start29 Jun 2016
  3. Primary completionJun 2017
  4. Study completionJun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03414333
Sponsor's protocol ID
PRA 2016
Status last verified
Jul 2018
First submitted
15 Jan 2018
Last updated
19 Jul 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Dardano A, Aghakhanyan G, Moretto C, Ciccarone A, Bellini R, Sancho Bornez V, Ceccarini G, Santini F, Volterrani D, Del Prato S, Daniele G. Brain effect of bariatric surgery in people with obesity. Int J Obes (Lond). 2022 Sep;46(9):1671-1677. doi: 10.1038/s41366-022-01162-8. Epub 2022 Jun 21.

    PubMed 35729365

Questions about this trial

What is this clinical trial studying?

A study testing RYGB and GLP-1 in people with Glucose Metabolism Disorders and Obesity, run by University of Pisa 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 13 inclusion and 16 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 19 Jul 2018. 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?

sustained Weight Loss (time frame: 6 months). 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 NCT03414333, 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 19 Jul 2018.

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