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

University Hospital, Gentofte, Copenhagen

Status: Completed

Conditions: Maturity-onset Diabetes of the Young

Treatments: Dietary Supplement: Meal test; Other: iso glycaemic intravenous (iv) glucose infusion (IIGI); Other: Oral Glucose Tolerance Test (OGTT); Other: Sitagliptin; Other: Incretin effect on sulphonyl urea treatment

Study type: Observational

Funder types: Other

Identifiers

NCT01342939

MODY-INK

H-1-2010-130 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

31 participants in 3 patient groups

MODY2

Description:

Also called GCK (glucokinase) MODY. They have a specific mutation in the GCK gene.

Treatment:

Other: Incretin effect on sulphonyl urea treatment

Other: Oral Glucose Tolerance Test (OGTT)

Dietary Supplement: Meal test

Other: iso glycaemic intravenous (iv) glucose infusion (IIGI)

MODY3

Description:

Also called HNF1 alfa MODY. They have a specific mutation in the HNF1 alfa gene.

Treatment:

Other: Incretin effect on sulphonyl urea treatment

Other: Oral Glucose Tolerance Test (OGTT)

Dietary Supplement: Meal test

Other: iso glycaemic intravenous (iv) glucose infusion (IIGI)

Healthy control subjects

Treatment:

Other: Sitagliptin

Other: Oral Glucose Tolerance Test (OGTT)

Dietary Supplement: Meal test

Other: iso glycaemic intravenous (iv) glucose infusion (IIGI)