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

Postprandial Secretion of of Incretin Hormones and Incretin Effect in Patients With Maturity-onset Diabetes of the Young (MODY)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01342939

Enrollment

Registered

2011-04-27

Start date

2011-01-31

Completion date

2011-12-31

Last updated

2013-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maturity-onset Diabetes of the Young

Keywords

Monogenetic diabetes, Diabetes mellitus

Brief summary

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.

Detailed description

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.

Interventions

OTHEROral Glucose Tolerance Test (OGTT)

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

OTHERiso glycaemic intravenous (iv) glucose infusion (IIGI)

20% glucose

DIETARY_SUPPLEMENTMeal test

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

OTHERSitagliptin

Healthy control subject are given an acute dosage of 100mg the evening before the experimental day, and the same morning in order to increase levels of endogen incretin hormones

OTHERIncretin effect on sulphonyl urea treatment

Subject with MODY who are treated with sulphonyl urea are investigated without medication break prior to examination.

Study design

Observational model

COHORT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Incretin effect	Within 1 year	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.

Secondary

Measure	Time frame	Description
Plasma GLP1 response	Within 1 year	Comparing GLP1 responses of the different experimental days, compared to healthy control subjects.
Plasma GIP response	Within 1 year	Comparing GIP responses of the different experimental days, compared to healthy control subjects.
Plasma glucagon response	Within 1 year	Comparing glucagon responses of the different experimental days, compared to healthy control subjects.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026