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Acute Effect of Exenatide on Brain Glucose Metabolism

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ClinicalTrials.gov Identifier: NCT01588418
Recruitment Status : Completed
First Posted : May 1, 2012
Results First Posted : May 25, 2017
Last Update Posted : November 24, 2017
Sponsor:
Collaborator:
Amylin Pharmaceuticals, LLC.
Information provided by (Responsible Party):
Ralph DeFronzo, The University of Texas Health Science Center at San Antonio

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Conditions: Impaired Glucose Tolerance (IGT)
Diabetes
Interventions: Drug: Exenatide
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
OGTT-PET: Exenatide First Then Placebo In the first study subjects received exenatide 5ug injected before OGTT-PET. In the second study (3 to 12 wk after first study), subjects received placebo injection before OGTT-PET
OGTT-PET: Placebo First, Then Exenatide In the first study subjects received placebo injected before OGTT-PET. In the second study (3 to 12 wk after first study), subjects received exenatide injection (5ug) before OGTT-PET

Participant Flow:   Overall Study
    OGTT-PET: Exenatide First Then Placebo   OGTT-PET: Placebo First, Then Exenatide
STARTED   11   4 
COMPLETED   11   4 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
We studied male subjects with impaired fasting glucose or newly diagnosed type 2 diabetes.

Reporting Groups
  Description
PET With Exenatide vs Placebo Injection

All subjects will receive the same intervention with Exenatide and placebo. Exenatide or placebo will be administered in random order, (i.e. first or second before OGTT-PET study).

In the first study IGT male subjects will be randomized to exenatide or placebo injection before OGTT-PET study. In the second study the same subjects will receive placebo or exenatide respectively before OGTT-PET study. The results obtained after Exenatide injection will be compared with the ones obtained after injection of placebo in the same subject.

Baseline Measures
   PET With Exenatide vs Placebo Injection 
Overall Participants Analyzed 
[Units: Participants]
 		 15 
Age 
[Units: Participants]
Count of Participants 		 
<=18 years      0   0.0% 
Between 18 and 65 years      15 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation) 		 57  (6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		 
Female      0   0.0% 
Male      15 100.0% 
Region of Enrollment 
[Units: Participants]
 		 
United States   15 
BMI (Body Mass Index) 
[Units: Kg/m^2]
Mean (Standard Deviation) 		 29  (3) 
Fasting plasma glucose 
[Units: Mg/dl]
Mean (Standard Deviation) 		 114  (3) 
HbA1c 
[Units: % of total hemoglobin]
Mean (Standard Deviation) 		 5.6  (0.1) 
2 hour plasma glucose concentration [1] 
[Units: Mg/dl]
Mean (Standard Deviation) 		 177  (11) 
[1] glucose concentration at 2h during screening OGTT


  Outcome Measures

1.  Primary:   Effect of Exenatide on Brain (Total Gray Matter) Glucose Metabolism   [ Time Frame: 120 minutes after exenatide or placebo injection ]
  Show Outcome Measure 1

2.  Secondary:   Effect of Exenatide on the Liver and Adipose Tissue Glucose Uptake   [ Time Frame: 60 minutes after exenatide or placebo injection ]
  Show Outcome Measure 2


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Our study has several potential limitations. It included only men. During OGTT it is difficult to evaluate the separate contributions of glucose and insulin.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Ralph DeFronzo
Organization: University of Texas Health Science Center at San Antonio
phone: 210-567-6691
e-mail: defronzo@uthscsa.edu


Publications of Results:


Responsible Party: Ralph DeFronzo, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT01588418     History of Changes
Other Study ID Numbers: 233-GAS-08
First Submitted: March 19, 2012
First Posted: May 1, 2012
Results First Submitted: October 28, 2015
Results First Posted: May 25, 2017
Last Update Posted: November 24, 2017