Glucagon in MODY (Maturity Onset Diabetes of the Young)

NCT ID: NCT03246828

Last Updated: 2022-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-03

Study Completion Date

2022-08-01

Brief Summary

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The aim of this study is to determine whether fasting and post-prandial glucagon secretion is suppressed by gliclazide in patients with HNF1-/4-alpha MODY. Participants will undergo an oral glucose tolerance test (OGTT) before and after omitting their gliclazide medication for 3 days.

Detailed Description

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Conditions

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MODY1 MODY3

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Omission of gliclazide

Group Type EXPERIMENTAL

Omission of gliclazide

Intervention Type OTHER

Participants will stop taking gliclazide for 3 days. Data from the OGTT will be compared with that prior to stopping the medication.

Interventions

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Omission of gliclazide

Participants will stop taking gliclazide for 3 days. Data from the OGTT will be compared with that prior to stopping the medication.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of HNF1-alpha or HNF4-alpha MODY.
* Currently on gliclazide treatment

Exclusion Criteria

* Currently taking any anti-diabetic medication other than gliclazide and metformin
* Oral steroid treatment 30 days prior to the start or at any time during the study period.
* Known malignancy or any other condition or circumstance which, in the opinion of the investigator, would affect the patient's ability to participate in the protocol.
* Felt to be unsuitable to participate in the study in the opinion of the Chief Investigator.
* Currently participating in a clinical trial involving an anti-diabetic medication
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oxford University Hospitals NHS Trust

OTHER

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ioannis Spiliotis, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

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Clinical Research Unit, OCDEM, Churchill Hospital

Oxford, Oxfordshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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12538

Identifier Type: -

Identifier Source: org_study_id

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