Glucagon in MODY (Maturity Onset Diabetes of the Young)

Study Overview
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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.

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

Conditions
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MODY1, MODY3

Intervention / Treatment
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* Other: Omission of gliclazide


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omission of gliclazide<br> | Other: Omission of gliclazide<br>* Participants will stop taking gliclazide for 3 days. Data from the OGTT will be compared with that prior to stopping the medication.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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) | 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) | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gliclazide, glucagon, diabetes