Glucagon in MODY (Maturity Onset Diabetes of the Young)

Sponsor

University of Oxford (Other)

Overall Status

Completed

CT.gov ID

NCT03246828

Collaborator

Oxford University Hospitals NHS Trust (Other)

Enrollment

Location

Arm

60.9

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
MODY1 MODY3	Other: Omission of gliclazide	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 3, 2017

Actual Primary Completion Date :

Jul 29, 2022

Actual Study Completion Date :

Aug 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in plasma glucagon from baseline (0min) [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.

Secondary Outcome Measures

Change in plasma c-peptide from baseline (0min) [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.
Change in plasma non-esterified fatty acids (NEFA) from baseline (0min) [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.
Continuous glucose monitor recordings [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Research Unit, OCDEM, Churchill Hospital	Oxford	Oxfordshire	United Kingdom	OX3 7LE

Sponsors and Collaborators

University of Oxford
Oxford University Hospitals NHS Trust

Investigators

Principal Investigator: Ioannis Spiliotis, MD, University of Oxford

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Oxford

ClinicalTrials.gov Identifier:

NCT03246828

Other Study ID Numbers:

12538

First Posted:

Aug 11, 2017

Last Update Posted:

Aug 17, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Oxford

gliclazide

glucagon

diabetes

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2

Gliclazide

Study Results

No Results Posted as of Aug 17, 2022