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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Gentofte, Copenhagen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Copenhagen
Steno Diabetes Center Copenhagen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 15, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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