Glucagon in MODY (Maturity Onset Diabetes of the Young)

MODY1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03246828
• Other study ID #: 12538
• Status: Completed
• Phase: N/A
• Start date: July 3, 2017
• Est. completion date: August 1, 2022

Study information

• Verified date: August 2022
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• MODY1
• MODY3

Intervention

Other:
• Omission of gliclazide
Participants will stop taking gliclazide for 3 days. Data from the OGTT will be compared with that prior to stopping the medication.

Locations

Country	Name	City	State
United Kingdom	Clinical Research Unit, OCDEM, Churchill Hospital	Oxford	Oxfordshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	Oxford University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

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