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Trial · Interventional

CompletedPhase 4Results postedRegistry data

Acute Effect of Exenatide on Brain Glucose Metabolism

NCTNCT01588418 (opens ClinicalTrials.gov in a new tab)Other id233-GAS-08
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
15 participants (actual)
Sponsor
The University of Texas Health Science Center at San Antonio · Other
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
Jul 2010
Primary completion
Jul 2015
Completion
Jul 2015
First posted
1 May 2012 (estimated)
Last update posted
24 Nov 2017
Conditions
Impaired Glucose Tolerance (IGT) · Diabetes

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2010201120122013201420152016
  1. Ph 4

    Acute Effect of Exenatide on Brain Glucose Metabolism

    NCT01588418

    Jul 2010 to Jul 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • ExenatideDrug
  • PlaceboDrug

Arms2

  • Experimental

    Exenatide first, then Placebo

    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.

  • Experimental

    Placebo first, then Exenatide

    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 .

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Effect of Exenatide on Brain (Total Gray Matter) Glucose Metabolism

    Time frame · 120 minutes after exenatide or placebo injection

    Registry description

    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.

Secondary outcomes(1)

  1. Effect of Exenatide on the Liver and Adipose Tissue Glucose Uptake

    Time frame · 60 minutes after exenatide or placebo injection

    Registry description

    we evaluated the acute effects of exenatide on hepatic (Hep-IR) and adipose (Adipo-IR) insulin resistance and glucose uptake.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 120 minutes after exenatide or placebo injection

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

GroupValue (μmol/(ml*min))Spread
Effect of Exenatide or Placebo on CMRglu0.140.02
Secondary and other outcome results(1)
Secondary outcome· 60 minutes after exenatide or placebo injection

Effect of Exenatide on the Liver and Adipose Tissue Glucose Uptake

GroupValue
Exenatide First, Then Placebonot posted
Placebo First, Then Exenatidenot posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
PET With Exenatide or Placebo InjectionThis is a crossover study where all subjects received the same intervention with Exenatide and placebo, acutely in random order, (i.e. first or second before OGTT-PET study).–0 / 150 / 15

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2016

8 results

Exenatide improves both hepatic and adipose tissue insulin resistance: A dynamic positron emission tomography study.

Gastaldelli et al. 2016Hepatology (Baltimore, Md.)cited by 83

PMID 27639082DOI 10.1002/hep.28827PUB-27639082

Full text at the publisher8 results
Publisher pageSee results (8)

Indexing hint: Randomized controlled trial · 2015

6 results

Exenatide Regulates Cerebral Glucose Metabolism in Brain Areas Associated With Glucose Homeostasis and Reward System.

Daniele et al. 2015Diabetescited by 54

PMID 26116695PMC6908417DOI 10.2337/db14-1718PUB-26116695

Rights unknown6 results
Source linkSee results (6)

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Males age 18-65 years old 2. Patients must have Body Mass Index (BMI) between 25 and 40 kg/m2 3. 2-hour glucose concentration above 140mg/dl after 75g glucose load, ie, having impaired glucose tolerance or newly diagnosed type 2 diabetes. 4. Patients must have BMI of 25-40 kg/m2 5. Patients must have no known severe liver or kidney disease, cancer, neurologic, psychiatric or systemic disease, ability to understand the study. 6. Only patients whose body weight has been stable (±3-4 pounds) over the three months prior to study will be included. 7. 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 Exclusion Criteria: Patients are excluded from participation in the study if they meet any of the following criteria: 1. Patients with major chronic illness (cancer, liver, kidney, cardiovascular disease) 2. Patients with BMI over 40 and under 25 3. Patient with age below 18 yrs and over 65 yrs 4. Female subjects 5. Patients with type 1 diabetes 6. Patients treated for type 2 diabetes 7. Subjects with normal glucose tolerance (NGT)

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