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Glucagon in MODY (Maturity Onset Diabetes of the Young)

Primary Purpose

MODY1, MODY3

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Omission of gliclazide
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for MODY1 focused on measuring gliclazide, glucagon, diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Research Unit, OCDEM, Churchill Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Omission of gliclazide

Arm Description

Outcomes

Primary Outcome Measures

Change in plasma glucagon from baseline (0min)
Change in the concentration of plasma glucagon from baseline during an oral glucose tolerance test (OGTT), while on gliclazide and after a washout period.

Secondary Outcome Measures

Change in plasma c-peptide from baseline (0min)
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.
Change in plasma non-esterified fatty acids (NEFA) from baseline (0min)
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.
Continuous glucose monitor recordings
To assess the blood glucose variability on and off gliclazide treatment (only for participants who opt to take part in this optional component).

Full Information

First Posted
July 4, 2017
Last Updated
August 16, 2022
Sponsor
University of Oxford
Collaborators
Oxford University Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03246828
Brief Title
Glucagon in MODY (Maturity Onset Diabetes of the Young)
Official Title
Investigating Glucagon Secretion in HNF1-alpha and HNF4-alpha MODY
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
July 3, 2017 (Actual)
Primary Completion Date
July 29, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
Collaborators
Oxford University Hospitals NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MODY1, MODY3
Keywords
gliclazide, glucagon, diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Omission of gliclazide
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Omission of gliclazide
Intervention Description
Participants will stop taking gliclazide for 3 days. Data from the OGTT will be compared with that prior to stopping the medication.
Primary Outcome Measure Information:
Title
Change in plasma glucagon from baseline (0min)
Description
Change in the concentration of plasma glucagon from baseline during an oral glucose tolerance test (OGTT), while on gliclazide and after a washout period.
Time Frame
0min, 30min, 60min, 90min and 120min during 75g oral glucose tolerance test.
Secondary Outcome Measure Information:
Title
Change in plasma c-peptide from baseline (0min)
Description
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.
Time Frame
0min, 30min, 60min, 90min and 120min during 75g oral glucose tolerance test.
Title
Change in plasma non-esterified fatty acids (NEFA) from baseline (0min)
Description
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.
Time Frame
0min, 30min, 60min, 90min and 120min during 75g oral glucose tolerance test.
Title
Continuous glucose monitor recordings
Description
To assess the blood glucose variability on and off gliclazide treatment (only for participants who opt to take part in this optional component).
Time Frame
12 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ioannis Spiliotis, MD
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Unit, OCDEM, Churchill Hospital
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 7LE
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Glucagon in MODY (Maturity Onset Diabetes of the Young)

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