Glucagon in MODY (Maturity Onset Diabetes of the Young)

August 16, 2022 updated by: University of Oxford

Investigating Glucagon Secretion in HNF1-alpha and HNF4-alpha MODY

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7LE
        • Clinical Research Unit, OCDEM, Churchill Hospital

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Omission of gliclazide
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in plasma glucagon from baseline (0min)
Time Frame: 0min, 30min, 60min, 90min and 120min during 75g oral glucose tolerance test.
Change in the concentration of plasma glucagon from baseline during an oral glucose tolerance test (OGTT), while on gliclazide and after a washout period.
0min, 30min, 60min, 90min and 120min during 75g oral glucose tolerance test.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in plasma c-peptide from baseline (0min)
Time Frame: 0min, 30min, 60min, 90min and 120min during 75g oral glucose tolerance test.
To determine whether changes in post-prandial glucagon levels correlate with changes in c-peptide levels in HNF1-/4-alpha MODY patients on and off gliclazide.
0min, 30min, 60min, 90min and 120min during 75g oral glucose tolerance test.
Change in plasma non-esterified fatty acids (NEFA) from baseline (0min)
Time Frame: 0min, 30min, 60min, 90min and 120min during 75g oral glucose tolerance test.
To determine whether changes in post-prandial glucagon levels correlate with changes in NEFA levels in HNF1-/4-alpha MODY patients on and off gliclazide.
0min, 30min, 60min, 90min and 120min during 75g oral glucose tolerance test.
Continuous glucose monitor recordings
Time Frame: 12 days
To assess the blood glucose variability on and off gliclazide treatment (only for participants who opt to take part in this optional component).
12 days

Collaborators and Investigators

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

Sponsor

University of Oxford

Collaborators

Oxford University Hospitals NHS Trust

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 (ACTUAL)

July 3, 2017

Primary Completion (ACTUAL)

July 29, 2022

Study Completion (ACTUAL)

August 1, 2022

Study Registration Dates

First Submitted

July 4, 2017

First Submitted That Met QC Criteria

August 8, 2017

First Posted (ACTUAL)

August 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 17, 2022

Last Update Submitted That Met QC Criteria

August 16, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12538

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The anonymised data (i.e. with studyID only) generated from this study will be deposited in the Oxford Research Archive (http://ora.ox.ac.uk/). This will provide a link between the results presented in publications and the underlying data. At the end of the retention period (currently 5 years), the data will be deleted from the archive. The anonymised data may still be used in future research.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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