Pathophysiological Implications of the Incretin Hormones in Maturity Onset of Diabetes of the Young (MODY)

University Hospital, Gentofte, Copenhagen31 enrolled

Overview

The purpose of this study is to describe the incretin effect and postprandial incretin response in patients with MODY2 and MODY3 and a group of matched healthy subjects. In sulphonyl urea treated subjects the purpose is also to compare the incretin effect with and without treatment. In healthy subjects the purpose is also to investigate the incretin effect under increased levels of endogen incretin hormones.

Comparison of of insulin secretion (AUC) during the experimental days. Furthermore a comparison of GIP, GLP1 and glucagon responses as well as plasma glucose levels.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Maturity-onset Diabetes of the Young

Interventions

Oral Glucose Tolerance Test (OGTT)OTHER

50g waterfree glucose dissolved in 300ml water consumed over 5 min.

iso glycaemic intravenous (iv) glucose infusion (IIGI)OTHER

20% glucose

Meal testDIETARY_SUPPLEMENT

Energy drink, 350ml (525 kcal: 65 g carbohydrates, 20 g fat and 21 g protein)

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Caucasians above 18 years * BMI \> 19 kg/m2 * Negative pancreatic beta cell- and glutamate decarboxylase-65(GAD65)- autoantibodies * Normal haemoglobin * Normal bloodpressure * Informed concent Exclusion Criteria: * Known liver disease or affected liver enzymes (ALAT/ASAT \>2 x upper normal limit) * Nephropathy (see creatinine\> 130 μM and / or albuminuria) * Treatment with medications that cannot be discontinued for 12 hours * Any condition that the investigators feel would interfere with trial participation * Pregnancy or lactation

Locations (1)

Diabetes Research Division, Gentofte University Hospital, Niels Andersens vej 65, opgang 40, 2.

Hellerup, Denmark

Outcomes

Primary Outcomes

Incretin effect

The difference in insulin responses, as assessed by the area under curve (AUC) for plasma insulin and C-peptide concentrations, during the two different glucose stimuli: OGTT and isoglycemic iv glucose infusion aswell as after a test meal in MODY-patients compared to healthy control subjects.

Time frame: Within 1 year

Secondary Outcomes

Plasma GLP1 response

Comparing GLP1 responses of the different experimental days, compared to healthy control subjects.

Time frame: Within 1 year

Plasma GIP response

Comparing GIP responses of the different experimental days, compared to healthy control subjects.

Time frame: Within 1 year

Plasma glucagon response

Comparing glucagon responses of the different experimental days, compared to healthy control subjects.

Time frame: Within 1 year

Data from ClinicalTrials.gov

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