MODY1, MODY3
Conditions
Keywords
gliclazide, glucagon, diabetes
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.
Interventions
OTHEROmission of gliclazide
Participants will stop taking gliclazide for 3 days. Data from the OGTT will be compared with that prior to stopping the medication.
Sponsors
Oxford University Hospitals NHS Trust
University of Oxford
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United Kingdom
Outcome results
None listed