Sugar-replacement Sweeteners, and Blood Sugar Control (SIR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marta Yanina Pepino de Gruev, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01128829
First received: May 20, 2010
Last updated: December 15, 2014
Last verified: December 2014
Results First Received: June 2, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Condition: Obesity
Interventions: Other: Water
Other: Sucralose

  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
"Water Then Sucralose"

First intervention (1 day) subjects drank 60 ml of water 10 min before drinking a 75 g glucose load.

Washout (~ 7 days) Second intervention (1 day) subjects drank 60 ml of 2 mmolar sucralose 10 min before drinking a 75 g glucose load.

"Sucralose Then Water"

First intervention (1 day) subjects drank 60 ml of 2 mmolar sucralose10 min before drinking a 75 g glucose load.

Washout (~ 7 days) Second intervention (1 day) subjects drank 60 ml of water 10 min before drinking a 75 g glucose load.


Participant Flow:   Overall Study
    "Water Then Sucralose"     "Sucralose Then Water"  
STARTED     6     11  
COMPLETED     6     11  
NOT COMPLETED     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.
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Reporting Groups
  Description
Obese Non Regular Users of Non Nutritive Sweeteners (NNS) Obese subjects who do not use NNS and are “insulin-sensitive” (based on a Homeostasis Model Assessment of Insulin Resistance score <or =2.6).

Baseline Measures
    Obese Non Regular Users of Non Nutritive Sweeteners (NNS)  
Number of Participants  
[units: participants]
  17  
Age  
[units: years]
Mean ± Standard Deviation
  35.1  ± 4.1  
Gender  
[units: participants]
 
Female     15  
Male     2  



  Outcome Measures

1.  Primary:   The Effect of Sucralose on Insulin Concentration (Area Under the Curve; AUC)   [ Time Frame: Baseline ]


  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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: M. Yanina Pepino
Organization: Washington University School of Medicine
phone: 3143628113
e-mail: ypepino@dom.wustl.edu


No publications provided by Washington University School of Medicine

Publications automatically indexed to this study:

Responsible Party: Marta Yanina Pepino de Gruev, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01128829     History of Changes
Other Study ID Numbers: 09-0583/ 201102383
Study First Received: May 20, 2010
Results First Received: June 2, 2014
Last Updated: December 15, 2014
Health Authority: United States: Institutional Review Board