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Completed

NCT Number: NCT03246828

Glucagon in MODY (Maturity Onset Diabetes of the Young)

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.

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Key information

Conditions

MODY1 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders MODY3 Maturity-Onset Diabetes of the Young, Type 1 Maturity-Onset Diabetes of the Young, Type 3 Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Research Unit, OCDEM, Churchill Hospital

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omission of gliclazide

Other

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

Primary outcomes

  1. Change in plasma glucagon from baseline (0min)

    Time frame: 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 outcomes

  1. Change in plasma c-peptide from baseline (0min)

    Time frame: 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.

  2. Change in plasma non-esterified fatty acids (NEFA) from baseline (0min)

    Time frame: 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.

  3. Continuous glucose monitor recordings

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • Oxford University Hospitals NHS Trust

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Aug 11, 2017
Registry last updated
Aug 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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