Glucagon in MODY (Maturity Onset Diabetes of the Young)
- Conditions
- MODY3MODY1
- 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
- Diagnosis of HNF1-alpha or HNF4-alpha MODY.
- Currently on gliclazide treatment
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Omission of gliclazide Omission of gliclazide -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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).
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