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Sulfonylurea Response in Patients With Diabetes Due to Kir6.2 Mutations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00334711
Recruitment Status : Completed
First Posted : June 8, 2006
Last Update Posted : November 29, 2006
Sponsor:
Collaborators:
Wellcome Trust
Hôpital Necker-Enfants Malades
Haukeland University Hospital
Information provided by:
Royal Devon and Exeter NHS Foundation Trust

Study Description
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Brief Summary:
The purpose of this study is to investigate whether patients with diabetes due to Kir6.2 mutations can be treated with sulfonylurea medication rather than insulin, and if this is the case to investigate the mechanism for sulfonylurea response.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Sulfonylurea Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Study of Sulfonylureas in Patients With Diabetes Due to Kir6.2 Mutations
Study Start Date : January 2004
Study Completion Date : January 2006
Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. HbA1c reduction

Secondary Outcome Measures :
  1. insulin secretory response to intravenous glucose
  2. insulin secretory response to oral glucose
  3. insulin secretory response to mixed meal (sustacal)
  4. Incidence of Hypoglycemia

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diabetes due to KCNJ11 (Kir6.2) mutation

Exclusion Criteria:

  • None
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00334711


Sponsors and Collaborators
Royal Devon and Exeter NHS Foundation Trust
Wellcome Trust
Hôpital Necker-Enfants Malades
Haukeland University Hospital
Investigators
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Study Director: Andrew T Hattersley Peninsula Medical School, Exeter, UK
Principal Investigator: Ewan R Pearson Peninsula Medical School, Exeter, UK
More Information
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Additional Information:

Publications of Results:

Other Publications:

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ClinicalTrials.gov Identifier: NCT00334711    
Other Study ID Numbers: 2003/10/196
97/29/AH/mbs NTNU
Jnr 207/mkd NTNU
CCPPRB Necker GLIDKIR6.2
First Posted: June 8, 2006    Key Record Dates
Last Update Posted: November 29, 2006
Last Verified: June 2006
Keywords provided by Royal Devon and Exeter NHS Foundation Trust:
Permanent Neonatal Diabetes
Kir6.2
KCNJ11
Infancy onset diabetes
Sulfonylurea
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases