Impaired Glucose Tolerance (IGT)Phase 4NCT01588418

Acute Effect of Exenatide on Brain Glucose Metabolism

A Phase 4 study testing Exenatide in people with Impaired Glucose Tolerance (IGT) and Diabetes, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.

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

This research study will examine brain glucose metabolism after an overnight fast to determine the effect of exenatide on brain glucose metabolism and lipid metabolism. Read more about this study

Who is it for?: Ages 18 to 65 years, men only
Conditions the study is for: Impaired Glucose Tolerance (IGT), Diabetes
What is being tested?: Exenatide
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 15 participants
Where: 1 siteUnited States
Study dates: Jul 2010to Jul 2015
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Males age 18-65 years old
Patients must have Body Mass Index (BMI) between 25 and 40 kg/m2
2-hour glucose concentration above 140mg/dl after 75g glucose load, ie, having impaired glucose tolerance or newly diagnosed type 2 diabetes.
Patients must have BMI of 25-40 kg/m2
Patients must have no known severe liver or kidney disease, cancer, neurologic, psychiatric or systemic disease, ability to understand the study.
Only patients whose body weight has been stable (±3-4 pounds) over the three months prior to study will be included.

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Patients must have the following laboratory values:
Hematocrit ≥ 34 vol%
Serum creatinine* ≤ 1.5 mg/dl in males and
Aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT): ≤ 2.5 times upper limit of normal
Alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT): ≤ 2.5 times upper limit of normal
Alkaline phosphatase ≤ 2.5 times upper limit of normal
If serum creatinine is ≤ 1.5 mg/dl in males, the PI can grant an exception and not exclude the patient if the Glomerular filtration rate (GFR) is >70 ml/min

Who cannot join

Patients are excluded from participation in the study if they meet any of the following criteria:
Patients with major chronic illness (cancer, liver, kidney, cardiovascular disease)
Patients with BMI over 40 and under 25
Patient with age below 18 yrs and over 65 yrs
Female subjects
Patients with type 1 diabetes
Patients treated for type 2 diabetes
Subjects with normal glucose tolerance (NGT)

Trial locations and contacts

1 site in 1 country.

United States1 site

Texas Diabetes Institute and UTHSCSA
San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: Effect of Exenatide on Brain Glucose Uptake in Relations to Pancreatic, Adipose Tissue, and Hepatic Function

This research study will examine brain glucose metabolism after an overnight fast to determine the effect of exenatide on brain glucose metabolism and lipid metabolism.

Read the detailed description

This study will elucidate if exenatide has an effect on brain glucose metabolism. This will be accomplished by measuring the rate of glucose binding in various brain regions by Positron Emission Tomography (PET) after glucose load with exenatide injection and compare it with placebo injection measured in the same subject. The changes will be compared with peripheral and hepatic glucose metabolism and lipolysis.

Conditions: Impaired Glucose Tolerance (IGT), Diabetes
Being tested: Exenatide, Placebo
Keywords: Impaired glucose tolerance (IGT), Diabetes
Medical subject headings: Glucose Intolerance, Diabetes Mellitus

What participants receive

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

ExenatideDrug
Also called Byetta
Exenatide (5mcg) was administered in random order 30 min before OGTT-PET study, crossover study
PlaceboDrug
Placebo was administered in random order 30 min before OGTT-PET study in the same subject

Study groups in NCT01588418
Study group	Role	What they receive
Exenatide first, then Placebo	Experimental	Exenatide 5mcg was injected subcutaneously 30 min before Oral Glucose Tolerance Test (OGTT)-PET study. The same subject was studied again a few weeks later with the same protocol with Placebo injection. Receives: Drug: Exenatide; Drug: Placebo
Placebo first, then Exenatide	Experimental	Placebo was injected subcutaneously 30 min before OGTT-PET study. The same subject was studied again a few weeks later with the same protocol with injection of Exenatide 5mcg . Receives: Drug: Exenatide; Drug: Placebo

What is being measured

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

Effect of Exenatide on Brain (Total Gray Matter) Glucose Metabolism
To study the acute effect of exenatide on brain glucose metabolism after the glucose load. Brain glucose uptake will be determined from serial FDG PET-imaging, by using graphical methods to quantify both global and regional results. The results obtained after Exenatide injection will be compared with the ones obtained after injection of placebo in the same subject.
Measured: 120 minutes after exenatide or placebo injection

Secondary outcomes (1)

Effect of Exenatide on the Liver and Adipose Tissue Glucose Uptake
we evaluated the acute effects of exenatide on hepatic (Hep-IR) and adipose (Adipo-IR) insulin resistance and glucose uptake.
Measured: 60 minutes after exenatide or placebo injection

Timeline

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

Jul 2010Jul 2015

First posted1 May 2012 (estimated)
Study startJul 2010
Primary completionJul 2015
Study completionJul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Impaired Glucose Tolerance (IGT)Studies of the same condition, open and under way.
More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
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: Interventional
Phase: Phase 4
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01588418
Sponsor's protocol ID: 233-GAS-08
Status last verified: Oct 2017
First submitted: 19 Mar 2012
Last updated: 24 Nov 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Daniele G, Iozzo P, Molina-Carrion M, Lancaster J, Ciociaro D, Cersosimo E, Tripathy D, Triplitt C, Fox P, Musi N, DeFronzo R, Gastaldelli A. Exenatide Regulates Cerebral Glucose Metabolism in Brain Areas Associated With Glucose Homeostasis and Reward System. Diabetes. 2015 Oct;64(10):3406-12. doi: 10.2337/db14-1718. Epub 2015 Jun 26.
PubMed 26116695
Gastaldelli A, Gaggini M, Daniele G, Ciociaro D, Cersosimo E, Tripathy D, Triplitt C, Fox P, Musi N, DeFronzo R, Iozzo P. Exenatide improves both hepatic and adipose tissue insulin resistance: A dynamic positron emission tomography study. Hepatology. 2016 Dec;64(6):2028-2037. doi: 10.1002/hep.28827.
PubMed 27639082

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Impaired Glucose Tolerance (IGT) trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Exenatide on Brain Glucose Uptake in Relations to Pancreatic, Adipose Tissue, and Hepatic Function
ClinicalTrials.gov ID: NCT01588418
Acronym / sponsor ID: 233-GAS-08
Conditions: Impaired Glucose Tolerance (IGT), Diabetes
Keywords: Impaired glucose tolerance (IGT), Diabetes
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: The University of Texas Health Science Center at San AntonioUniversity, hospital or other
Collaborators: Amylin Pharmaceuticals, LLC.
Study start: Jul 2010
Primary completion: Jul 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 1 May 2012 (estimated)
Results: Posted 25 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This research study will examine brain glucose metabolism after an overnight fast to determine the effect of exenatide on brain glucose metabolism and lipid metabolism.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Exenatide first, then Placebo	Experimental	Drug: Exenatide, Drug: PlaceboExenatide 5mcg was injected subcutaneously 30 min before Oral Glucose Tolerance Test (OGTT)-PET study. The same subject was studied again a few weeks later with the same protocol with Placebo injection.
Placebo first, then Exenatide	Experimental	Drug: Exenatide, Drug: PlaceboPlacebo was injected subcutaneously 30 min before OGTT-PET study. The same subject was studied again a few weeks later with the same protocol with injection of Exenatide 5mcg .

Who may qualify

Ages: 18 to 65 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Males age 18-65 years old
Patients must have Body Mass Index (BMI) between 25 and 40 kg/m2
2-hour glucose concentration above 140mg/dl after 75g glucose load, ie, having impaired glucose tolerance or newly diagnosed type 2 diabetes.
Patients must have BMI of 25-40 kg/m2
Patients must have no known severe liver or kidney disease, cancer, neurologic, psychiatric or systemic disease, ability to understand the study.

Key exclusion criteria (8 listed)

Patients are excluded from participation in the study if they meet any of the following criteria:
Patients with major chronic illness (cancer, liver, kidney, cardiovascular disease)
Patients with BMI over 40 and under 25
Patient with age below 18 yrs and over 65 yrs
Female subjects

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ExenatideAlso: ByettaExenatide (5mcg) was administered in random order 30 min before OGTT-PET study, crossover study	Drug	Exenatide first, then Placebo, Placebo first, then Exenatide
PlaceboPlacebo was administered in random order 30 min before OGTT-PET study in the same subject	Drug	Exenatide first, then Placebo, Placebo first, then Exenatide

Primary outcome

Effect of Exenatide on Brain (Total Gray Matter) Glucose Metabolism
Time frame: 120 minutes after exenatide or placebo injection
To study the acute effect of exenatide on brain glucose metabolism after the glucose load. Brain glucose uptake will be determined from serial FDG PET-imaging, by using graphical methods to quantify both global and regional results. The results obtained after Exenatide injection will be compared with the ones obtained after injection of placebo in the same subject.

1 secondary outcome

Effect of Exenatide on the Liver and Adipose Tissue Glucose Uptake
Time frame: 60 minutes after exenatide or placebo injection

Results and safety

Results posted to the registry on 25 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OGTT-PET: Exenatide First Then Placebo	11	11
OGTT-PET: Placebo First, Then Exenatide	4	4

Primary outcome: Effect of Exenatide on Brain (Total Gray Matter) Glucose Metabolism

Time frame: 120 minutes after exenatide or placebo injection. Mean (Standard Error). Unit: μmol/(ml*min)

Measure	Effect of Exenatide or Placebo on CMRglu n = 15
total gray matter CMRglu after Exenatide	0.14 (0.02)
total gray matter CMRglu after Placebo	0.10 (0.01)

Population analysed: We studied, in the same subject, the acute effect of injection of exenatide vs placebo on brain glucose metabolism (CMRglu) after the glucose load. We used FDG PET-imaging to quantify global and regional results.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PET With Exenatide or Placebo Injection	0 of 15 (0%)	0 of 15 (0%)	Not reported

Limitations and caveats (from the sponsor): Our study has several potential limitations. It included only men. During OGTT it is difficult to evaluate the separate contributions of glucose and insulin.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26116695Daniele G, Iozzo P, Molina-Carrion M, Lancaster J, Ciociaro D, Cersosimo E, Tripathy D, Triplitt C, Fox P, Musi N, DeFronzo R, Gastaldelli A. Exenatide Regulates Cerebral Glucose Metabolism in Brain Areas Associated With Glucose Homeostasis and Reward System. Diabetes. 2015 Oct;64(10):3406-12. doi: 10.2337/db14-1718. Epub 2015 Jun 26.
Results publication: PubMed 27639082Gastaldelli A, Gaggini M, Daniele G, Ciociaro D, Cersosimo E, Tripathy D, Triplitt C, Fox P, Musi N, DeFronzo R, Iozzo P. Exenatide improves both hepatic and adipose tissue insulin resistance: A dynamic positron emission tomography study. Hepatology. 2016 Dec;64(6):2028-2037. doi: 10.1002/hep.28827.
Individual participant dataSharing planned: No

Related trials for Impaired Glucose Tolerance (IGT)

Recruiting
Pre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT)
Diabetes Mellitus, Type 2, Impaired Glucose Tolerance (IGT)
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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.

Amalia Gastaldelli, PhD principal investigator

UTHSCSA, San Antonio, TX

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Exenatide in people with Impaired Glucose Tolerance (IGT) and Diabetes, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.

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 8 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 24 Nov 2017. 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 United States. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Effect of Exenatide on Brain (Total Gray Matter) Glucose Metabolism (time frame: 120 minutes after exenatide or placebo injection). 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 NCT01588418, which also lists 2 linked publications.

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 24 Nov 2017.