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

November 28, 2006 updated by: Royal Devon and Exeter NHS Foundation Trust

A Prospective Study of Sulfonylureas in Patients With Diabetes Due to Kir6.2 Mutations

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diabetes due to KCNJ11 (Kir6.2) mutation

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
HbA1c reduction

Secondary Outcome Measures

Outcome Measure
insulin secretory response to intravenous glucose
insulin secretory response to oral glucose
insulin secretory response to mixed meal (sustacal)
Incidence of Hypoglycemia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Devon and Exeter NHS Foundation Trust

Collaborators

Wellcome Trust
Haukeland University Hospital
Hôpital Necker-Enfants Malades

Investigators

  • Study Director: Andrew T Hattersley, Peninsula Medical School, Exeter, UK
  • Principal Investigator: Ewan R Pearson, Peninsula Medical School, Exeter, UK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Study Completion

January 1, 2006

Study Registration Dates

First Submitted

June 7, 2006

First Submitted That Met QC Criteria

June 7, 2006

First Posted (Estimate)

June 8, 2006

Study Record Updates

Last Update Posted (Estimate)

November 29, 2006

Last Update Submitted That Met QC Criteria

November 28, 2006

Last Verified

June 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2003/10/196
  • 97/29/AH/mbs NTNU
  • Jnr 207/mkd NTNU
  • CCPPRB Necker GLIDKIR6.2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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