Counter-Regulatory Impairment and the Effect of Microvascular Insulin Transfer in Type 1 Diabetes Mellitus (BPK003)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boris Kovatchev, PhD, University of Virginia
ClinicalTrials.gov Identifier:
NCT00943787
First received: June 24, 2009
Last updated: August 26, 2014
Last verified: August 2014
Results First Received: August 8, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: Diabetes Mellitus, Type 1
Intervention: Procedure: Hyperinsulinemic, euglycemic and hypoglycemic clamp

  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
Recruitment period: 2/2006-5/2009. Recruitment included outpatients at UVA clinics, former research subjects, and local advertising. All subjects ≥18 years of age and had type 1 diabetes defined by American Diabetes Association criteria or judgment of the study endocrinologist after review of the clinical history.

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
Adults With T1DM From Subjects Subjects with type 1 diabetes performed self-monitoring of blood glucose (SMBG) for a month, followed by an inpatient hyperinsulinemic euglycemic and hypoglycemic clamp. SMBG field data were used to calculate measures of glucose variability and risk of hypoglycemia, while the clamp procedure was used to evaluate insulin sensitivity and epinephrine response during induced hypoglycemia.

Participant Flow:   Overall Study
    Adults With T1DM From Subjects  
STARTED     41  
COMPLETED     34  
NOT COMPLETED     7  
Physician Decision                 4  
Withdrawal by Subject                 3  



  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
Adults With T1DM From Subjects Subjects with type 1 diabetes performed self-monitoring of blood glucose (SMBG) for a month, followed by an inpatient hyperinsulinemic euglycemic and hypoglycemic clamp. SMBG field data were used to calculate measures of glucose variability and risk of hypoglycemia, while the clamp procedure was used to evaluate insulin sensitivity and epinephrine response during induced hypoglycemia.

Baseline Measures
    Adults With T1DM From Subjects  
Number of Participants  
[units: participants]
  34  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     34  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  37  ± 2.1  
Gender  
[units: participants]
 
Female     14  
Male     20  
Region of Enrollment  
[units: participants]
 
United States     34  
Glycosylated hembglobin (HbA1c)  
[units: percent]
Mean ± Standard Deviation
  7.6  ± 0.21  



  Outcome Measures
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1.  Primary:   Maximum Epinephrine Response (LBGI Groups)   [ Time Frame: 285 min (time of clamp) ]

2.  Secondary:   Maximum Epinephrine Response (ADRR Groups)   [ Time Frame: 285 min (time of clamp) ]


  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: Mary Oliveri
Organization: University of Virginia
phone: 434-982-0602
e-mail: mc7m@virginia.edu


Publications:
Publications automatically indexed to this study:

Responsible Party: Boris Kovatchev, PhD, University of Virginia
ClinicalTrials.gov Identifier: NCT00943787     History of Changes
Other Study ID Numbers: 12252
Study First Received: June 24, 2009
Results First Received: August 8, 2014
Last Updated: August 26, 2014
Health Authority: United States: Institutional Review Board