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Glucagon in MODY (Maturity Onset Diabetes of the Young)

Not Applicable
Completed
Conditions
MODY3
MODY1
Interventions
Other: Omission of gliclazide
Registration Number
NCT03246828
Lead Sponsor
University of Oxford
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
10
Inclusion Criteria
  • Diagnosis of HNF1-alpha or HNF4-alpha MODY.
  • Currently on gliclazide treatment
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Omission of gliclazideOmission of gliclazide-
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
Continuous glucose monitor recordings12 days

To assess the blood glucose variability on and off gliclazide treatment (only for participants who opt to take part in this optional component).

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.

Trial Locations

Locations (1)

Clinical Research Unit, OCDEM, Churchill Hospital

🇬🇧

Oxford, Oxfordshire, United Kingdom

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