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

January 14, 2013 updated by: Signe H Østoft, MD, University Hospital, Gentofte, Copenhagen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hellerup, Denmark, 2900
        • Diabetes Research Division, Gentofte University Hospital, Niels Andersens vej 65, opgang 40, 2.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Genetically well-charaterized MODY2 and MODY3 patients at Hagedorn Research Institute/Steno Diabetes Center

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MODY2
Also called GCK (glucokinase) MODY. They have a specific mutation in the GCK gene.
Other: Oral Glucose Tolerance Test (OGTT)
50g waterfree glucose dissolved in 300ml water consumed over 5 min.
Other Names:
  • Waterfree glucose, The Pharmacy of the capital region
Other: iso glycaemic intravenous (iv) glucose infusion (IIGI)
20% glucose
Other Names:
  • Glucose infusion, 20%
Dietary supplement: Meal test
Energy drink, 350ml (525 kcal: 65 g carbohydrates, 20 g fat and 21 g protein)
Other Names:
  • Nutridrink with cocoa taste (Nutricia, Allerød, Denmark)
Other: Incretin effect on sulphonyl urea treatment
Subject with MODY who are treated with sulphonyl urea are investigated without medication break prior to examination.
MODY3
Also called HNF1 alfa MODY. They have a specific mutation in the HNF1 alfa gene.
Other: Oral Glucose Tolerance Test (OGTT)
50g waterfree glucose dissolved in 300ml water consumed over 5 min.
Other Names:
  • Waterfree glucose, The Pharmacy of the capital region
Other: iso glycaemic intravenous (iv) glucose infusion (IIGI)
20% glucose
Other Names:
  • Glucose infusion, 20%
Dietary supplement: Meal test
Energy drink, 350ml (525 kcal: 65 g carbohydrates, 20 g fat and 21 g protein)
Other Names:
  • Nutridrink with cocoa taste (Nutricia, Allerød, Denmark)
Other: Incretin effect on sulphonyl urea treatment
Subject with MODY who are treated with sulphonyl urea are investigated without medication break prior to examination.
Healthy control subjects
Other: Oral Glucose Tolerance Test (OGTT)
50g waterfree glucose dissolved in 300ml water consumed over 5 min.
Other Names:
  • Waterfree glucose, The Pharmacy of the capital region
Other: iso glycaemic intravenous (iv) glucose infusion (IIGI)
20% glucose
Other Names:
  • Glucose infusion, 20%
Dietary supplement: Meal test
Energy drink, 350ml (525 kcal: 65 g carbohydrates, 20 g fat and 21 g protein)
Other Names:
  • Nutridrink with cocoa taste (Nutricia, Allerød, Denmark)
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
Other Names:
  • Januvia, 100mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incretin effect
Time Frame: 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.
Within 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Gentofte, Copenhagen

Collaborators

University of Copenhagen
Steno Diabetes Center Copenhagen

Investigators

  • Principal Investigator: Signe H Østoft, MD, phd stud, Diabetes Research Division, University Hospital Gentofte, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

April 13, 2011

First Submitted That Met QC Criteria

April 26, 2011

First Posted (Estimate)

April 27, 2011

Study Record Updates

Last Update Posted (Estimate)

January 15, 2013

Last Update Submitted That Met QC Criteria

January 14, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MODY-INK
  • H-1-2010-130 (Registry Identifier: The Danish National Committee on Biomedical Research Ethics)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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