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

Maturity-onset Diabetes of the Young Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01342939
• Other study ID #: MODY-INK
• Secondary ID: H-1-2010-130
• Status: Completed
• Phase: N/A
• First received: April 13, 2011
• Last updated: January 14, 2013
• Start date: January 2011
• Est. completion date: December 2011

Study information

• Verified date: January 2013
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Maturity-onset Diabetes of the Young

Intervention

Other:
• Oral Glucose Tolerance Test (OGTT)
50g waterfree glucose dissolved in 300ml water consumed over 5 min.
• iso glycaemic intravenous (iv) glucose infusion (IIGI)
20% glucose

Dietary Supplement:
• Meal test
Energy drink, 350ml (525 kcal: 65 g carbohydrates, 20 g fat and 21 g protein)

Other:
• Sitagliptin
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
• Incretin effect on sulphonyl urea treatment
Subject with MODY who are treated with sulphonyl urea are investigated without medication break prior to examination.

Locations

Country	Name	City	State
Denmark	Diabetes Research Division, Gentofte University Hospital, Niels Andersens vej 65, opgang 40, 2.	Hellerup

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen	Steno Diabetes Center, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Within 1 year	No
Secondary	Plasma GLP1 response	Comparing GLP1 responses of the different experimental days, compared to healthy control subjects.	Within 1 year	No
Secondary	Plasma GIP response	Comparing GIP responses of the different experimental days, compared to healthy control subjects.	Within 1 year	No
Secondary	Plasma glucagon response	Comparing glucagon responses of the different experimental days, compared to healthy control subjects.	Within 1 year	No