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

NCT ID: NCT01342939

Last Updated: 2013-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Maturity-onset Diabetes of the Young

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MODY2

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

Oral Glucose Tolerance Test (OGTT)

Intervention Type OTHER

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

iso glycaemic intravenous (iv) glucose infusion (IIGI)

Intervention Type OTHER

20% glucose

Meal test

Intervention Type DIETARY_SUPPLEMENT

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

Incretin effect on sulphonyl urea treatment

Intervention Type OTHER

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.

Oral Glucose Tolerance Test (OGTT)

Intervention Type OTHER

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

iso glycaemic intravenous (iv) glucose infusion (IIGI)

Intervention Type OTHER

20% glucose

Meal test

Intervention Type DIETARY_SUPPLEMENT

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

Incretin effect on sulphonyl urea treatment

Intervention Type OTHER

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

Healthy control subjects

Oral Glucose Tolerance Test (OGTT)

Intervention Type OTHER

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

iso glycaemic intravenous (iv) glucose infusion (IIGI)

Intervention Type OTHER

20% glucose

Meal test

Intervention Type DIETARY_SUPPLEMENT

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

Sitagliptin

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Oral Glucose Tolerance Test (OGTT)

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

Intervention Type OTHER

iso glycaemic intravenous (iv) glucose infusion (IIGI)

20% glucose

Intervention Type OTHER

Meal test

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

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type OTHER

Incretin effect on sulphonyl urea treatment

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Waterfree glucose, The Pharmacy of the capital region Glucose infusion, 20% Nutridrink with cocoa taste (Nutricia, Allerød, Denmark) Januvia, 100mg

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Copenhagen

OTHER

Sponsor Role collaborator

Steno Diabetes Center Copenhagen

OTHER

Sponsor Role collaborator

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Signe H Østoft, MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Signe H Østoft, MD, phd stud

Role: PRINCIPAL_INVESTIGATOR

Diabetes Research Division, University Hospital Gentofte, Denmark

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Diabetes Research Division, Gentofte University Hospital, Niels Andersens vej 65, opgang 40, 2.

Hellerup, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

References

Explore related publications, articles, or registry entries linked to this study.

Ostoft SH, Bagger JI, Hansen T, Hartmann B, Pedersen O, Holst JJ, Knop FK, Vilsboll T. Postprandial incretin and islet hormone responses and dipeptidyl-peptidase 4 enzymatic activity in patients with maturity onset diabetes of the young. Eur J Endocrinol. 2015 Aug;173(2):205-15. doi: 10.1530/EJE-15-0070. Epub 2015 May 7.

Reference Type DERIVED
PMID: 25953829 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H-1-2010-130

Identifier Type: REGISTRY

Identifier Source: secondary_id

MODY-INK

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.