MODY1 Clinical Trial
Official title:
Investigating Glucagon Secretion in HNF1-alpha and HNF4-alpha MODY
NCT number | NCT03246828 |
Other study ID # | 12538 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 3, 2017 |
Est. completion date | August 1, 2022 |
Verified date | August 2022 |
Source | University of Oxford |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | August 1, 2022 |
Est. primary completion date | July 29, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Clinical Research Unit, OCDEM, Churchill Hospital | Oxford | Oxfordshire |
Lead Sponsor | Collaborator |
---|---|
University of Oxford | Oxford University Hospitals NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | |
Secondary | 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. | |
Secondary | 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 |