Study of Post-meal Blood Sugar Peaks in Association With Vascular Disease in Childhood Obesity

This study has been terminated.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00846521
First received: February 16, 2009
Last updated: April 29, 2013
Last verified: April 2013
Results First Received: March 7, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Pediatric Obesity
Insulin Resistance
Impaired Glucose Tolerance
Cardiovascular Disease
Intervention: Drug: Acarbose

  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
Acarbose Administration

Acarbose : Subjects assigned to treatment will receive an exact supply of Acarbose to cover the initial 5 weeks of intervention. The medication will be distributed by the investigational pharmacy. Subjects will be instructed on the dosing schedule as follows (due to potential gastrointestinal side effects, the dose will be increased incrementally to desired levels).

Tablets (dose) of acarbose: Week 1 - 25 mg once a day (with dinner); Week 2 - 50 mg once a day (with dinner); Week 3 - 25 mg with breakfast and 50 mg with dinner; Week 4 - 50 mg with breakfast, 25 mg with lunch and 50 mg with dinner; Week 5-7 - 50 mg with breakfast, 50 mg with lunch and 50 mg with dinner.


Participant Flow:   Overall Study
    Acarbose Administration  
STARTED     23  
COMPLETED     12  
NOT COMPLETED     11  
Withdrawal by Subject                 5  
Did not meet OGTT/ CGMS criteria                 5  
Protocol Violation                 1  



  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.
Baseline analysis was only done on subjects who completed the study

Reporting Groups
  Description
Acarbose Administration

Acarbose : Subjects assigned to treatment will receive an exact supply of Acarbose to cover the initial 5 weeks of intervention. The medication will be distributed by the investigational pharmacy. Subjects will be instructed on the dosing schedule as follows (due to potential gastrointestinal side effects, the dose will be increased incrementally to desired levels).

Tablets (dose) of acarbose: Week 1 - 25 mg once a day (with dinner); Week 2 - 50 mg once a day (with dinner); Week 3 - 25 mg with breakfast and 50 mg with dinner; Week 4 - 50 mg with breakfast, 25 mg with lunch and 50 mg with dinner; Week 5-7 - 50 mg with breakfast, 50 mg with lunch and 50 mg with dinner.


Baseline Measures
    Acarbose Administration  
Number of Participants  
[units: participants]
  12  
Age  
[units: years]
Mean ± Standard Deviation
  15.2  ± 1.1  
Gender  
[units: participants]
 
Female     5  
Male     7  



  Outcome Measures
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1.  Primary:   Mean Percentage of Glucose Values ≥ 140 mg/dl Over 72 Hours of Glucose Readings Measured With a Continuous Glucose Monitor   [ Time Frame: At baseline (before treatment) ]

2.  Primary:   Mean Percentage of Glucose Values ≥ 140 mg/dl Over 72 Hours of Glucose Readings Measured With a Continuous Glucose Monitor   [ Time Frame: After 6 Weeks (post treatment) ]


  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: Tania Burgurt, MD
Organization: Yale University School of Medicine
phone: 203-785-7152
e-mail: tania.burgurt@yale.edu


No publications provided


Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00846521     History of Changes
Other Study ID Numbers: 0603001202, 5K23DK74439-3
Study First Received: February 16, 2009
Results First Received: March 7, 2013
Last Updated: April 29, 2013
Health Authority: United States: Institutional Review Board