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Modulation of Human Myocardial Metabolism by GLP-1 Dose Response

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01607450
First received: May 21, 2012
Last updated: January 19, 2016
Last verified: January 2016
Results First Received: November 16, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Conditions: Type 2 Diabetes Mellitus
Healthy
Interventions: Drug: GLP-1 Low Dose
Drug: GLP-1 Mid-Range Dose
Drug: GLP-1 High Dose
Drug: Saline

  Participant Flow
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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
Lean Placebo

12 hour placebo (saline) infusion prior to PET study

Placebo: Saline placebo infusion for 12 hours prior to PET study

Lean GLP-1 Mid-Range Dose GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
Type 2 DM GLP-1 Mid-Range Dose GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
Lean GLP-1 Low Dose GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
Type 2 DM GLP-1 Low Dose GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
Lean GLP-1 High Dose GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study
Type 2 DM GLP-1 High Dose GLP-1 High Dose: 1.5 pmol/kg/min for 12 hours prior to PET study

Participant Flow:   Overall Study
    Lean Placebo     Lean GLP-1 Mid-Range Dose     Type 2 DM GLP-1 Mid-Range Dose     Lean GLP-1 Low Dose     Type 2 DM GLP-1 Low Dose     Lean GLP-1 High Dose     Type 2 DM GLP-1 High Dose  
STARTED     6     8     7     11     1     0     0  
COMPLETED     6     8     7     11     1     0     0  
NOT COMPLETED     0     0     0     0     0     0     0  



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Lean Saline

12 hour placebo (saline) infusion prior to PET study

Placebo: Saline placebo infusion for 12 hours prior to PET study

Lean GLP-1 0.5 Pmol/kg/Min GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
Type 2 DM GLP-1 0.5 Pmol/kg/Min GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
Lean GLP-1 1.5 Pmol/kg/Min GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
Type 2 DM GLP-1 1.5 Pmol/kg/Min GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
Lean GLP-1 4.0 Pmol/kg/Min GLP-1 High Dose:4.0 pmol/kg/min for 12 hours prior to PET study
Type 2 DM GLP-1 4.0 Pmol/kg/Min GLP-1 High Dose:4.0 pmol/kg/min for 12 hours prior to PET study
Total Total of all reporting groups

Baseline Measures
    Lean Saline     Lean GLP-1 0.5 Pmol/kg/Min     Type 2 DM GLP-1 0.5 Pmol/kg/Min     Lean GLP-1 1.5 Pmol/kg/Min     Type 2 DM GLP-1 1.5 Pmol/kg/Min     Lean GLP-1 4.0 Pmol/kg/Min     Type 2 DM GLP-1 4.0 Pmol/kg/Min     Total  
Number of Participants  
[units: participants]
  6     11     1     8     7     0     0     33  
Age  
[units: years]
Mean (Standard Deviation)
  35.5  (10.6)     38.0  (6.0)     42  (0)     46.0  (5.8)     45.1  (7.9)             42.7  (7.9)  
Gender  
[units: participants]
               
Female     5     3     0     3     1             12  
Male     1     8     1     5     6             21  
Region of Enrollment  
[units: participants]
               
United States     6     11     1     8     7             33  
Body Mass Index (kg/m2)  
[units: kg/m^2]
Mean (Standard Deviation)
  23.9  (1.6)     23.0  (1.5)     31.0  (0)     22.9  (1.8)     30.3  (1.7)             25.7  (1.7)  
HbA1c (%)  
[units: %]
Mean (Standard Deviation)
  5.47  (0.40)     5.47  (0.40)     7.0  (0)     5.56  (0.34)     8.40  (3.02)             6.48  (1.24)  



  Outcome Measures
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1.  Primary:   Myocardial Glucose Uptake.   [ Time Frame: After 12 hours of glucagon-like peptide 1 (GLP-1) exposure ]

2.  Secondary:   Myocardial Blood Flow   [ Time Frame: After 12 hours of GLP-1 exposure ]

3.  Secondary:   Myocardial Total Oxidation Rate   [ Time Frame: After 12 hours of GLP-1 exposure ]

4.  Secondary:   Cardiac Index   [ Time Frame: After 12 hours of GLP-1 exposure ]

5.  Secondary:   GLP-1 Concentrations   [ Time Frame: After 12 hours of GLP-1 exposure ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
This was a dose-finding study of myocardial responses to systemically infused GLP-1. After ascertaining no detectable response in controls with low dose, we completed mid dose studies. Finding an important difference there we did not do the high dose


  More Information
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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: Kieren J Mather MD FRCPC
Organization: Indiana University
phone: 317-278-7826
e-mail: kmather@iu.edu



Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01607450     History of Changes
Other Study ID Numbers: 1010002497
R21HL092799 ( US NIH Grant/Contract Award Number )
Study First Received: May 21, 2012
Results First Received: November 16, 2015
Last Updated: January 19, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board