Maturity-onset Diabetes of the YoungNCT01342939
Pathophysiological Implications of the Incretin Hormones in Maturity Onset of Diabetes of the Young (MODY)
An observational study of Maturity-onset Diabetes of the Young, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Maturity-onset Diabetes of the Young
- What is being tested?
- Oral Glucose Tolerance Test (OGTT), iso glycaemic intravenous (iv) glucose infusion (IIGI) and Meal test
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 31 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2011to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Genetically well-charaterized MODY2 and MODY3 patients at Hagedorn Research Institute/Steno Diabetes Center
Who may be able to join
- Caucasians above 18 years
- BMI > 19 kg/m2
- Negative pancreatic beta cell- and glutamate decarboxylase-65(GAD65)- autoantibodies
- Normal haemoglobin
- Normal bloodpressure
- Informed concent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Denmark1 site
Diabetes Research Division, Gentofte University Hospital, Niels Andersens vej 65, opgang 40, 2.
Hellerup, 2900
About this study
Official title: 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.
Read the 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.
- Conditions
- Maturity-onset Diabetes of the Young
- Being tested
- Oral Glucose Tolerance Test (OGTT), iso glycaemic intravenous (iv) glucose infusion (IIGI), Meal test, Sitagliptin, Incretin effect on sulphonyl urea treatment
- Keywords
- Monogenetic diabetes, Diabetes mellitus
- Medical subject headings
- Mason-Type Diabetes, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Glucose Tolerance Test (OGTT)Other
Also called Waterfree glucose, The Pharmacy of the capital region
50g waterfree glucose dissolved in 300ml water consumed over 5 min.
iso glycaemic intravenous (iv) glucose infusion (IIGI)Other
Also called Glucose infusion, 20%
20% glucose
Meal testDietary supplement
Also called Nutridrink with cocoa taste (Nutricia, Allerød, Denmark)
Energy drink, 350ml (525 kcal: 65 g carbohydrates, 20 g fat and 21 g protein)
SitagliptinOther
Also called Januvia, 100mg
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 treatmentOther
Subject with MODY who are treated with sulphonyl urea are investigated without medication break prior to examination.
| Study group | Role | What they receive |
|---|---|---|
| MODY2 | Also called GCK (glucokinase) MODY. They have a specific mutation in the GCK gene. Receives: Other: Oral Glucose Tolerance Test (OGTT); Other: iso glycaemic intravenous (iv) glucose infusion (IIGI); Dietary Supplement: Meal test; Other: Incretin effect on sulphonyl urea treatment | |
| MODY3 | Also called HNF1 alfa MODY. They have a specific mutation in the HNF1 alfa gene. Receives: Other: Oral Glucose Tolerance Test (OGTT); Other: iso glycaemic intravenous (iv) glucose infusion (IIGI); Dietary Supplement: Meal test; Other: Incretin effect on sulphonyl urea treatment | |
| Healthy control subjects | Not described Receives: Other: Oral Glucose Tolerance Test (OGTT); Other: iso glycaemic intravenous (iv) glucose infusion (IIGI); Dietary Supplement: Meal test; Other: Sitagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 1 year
Secondary outcomes (3)
Plasma GLP1 response
Comparing GLP1 responses of the different experimental days, compared to healthy control subjects.
Measured: Within 1 year
Plasma GIP response
Comparing GIP responses of the different experimental days, compared to healthy control subjects.
Measured: Within 1 year
Plasma glucagon response
Comparing glucagon responses of the different experimental days, compared to healthy control subjects.
Measured: Within 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2011 (estimated)
- Study startJan 2011
- Primary completionNov 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maturity-onset Diabetes of the YoungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Steno Diabetes Center Copenhagen
- Responsible party
- Principal investigator, Signe H Østoft, MD, University Hospital, Gentofte, Copenhagen
- Investigators
- Signe H Østoft, MD, phd stud, Principal investigator, Diabetes Research Division, University Hospital Gentofte, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01342939
- Sponsor's protocol ID
- MODY-INK
- Other IDs
- H-1-2010-130
- Status last verified
- Jan 2013
- First submitted
- 13 Apr 2011
- Last updated
- 15 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25953829
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Secretion of of Incretin Hormones and Incretin Effect in Patients With Maturity-onset Diabetes of the Young (MODY)
- ClinicalTrials.gov ID
- NCT01342939
- Acronym / sponsor ID
- MODY-INK
- Conditions
- Maturity-onset Diabetes of the Young
- Keywords
- Monogenetic diabetes, Diabetes mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Collaborators
- University of Copenhagen, Steno Diabetes Center Copenhagen
- Study start
- Jan 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 27 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MODY2 | – | Other: Oral Glucose Tolerance Test (OGTT), Other: iso glycaemic intravenous (iv) glucose infusion (IIGI), Dietary Supplement: Meal test, Other: Incretin effect on sulphonyl urea treatmentAlso called GCK (glucokinase) MODY. They have a specific mutation in the GCK gene. |
| MODY3 | – | Other: Oral Glucose Tolerance Test (OGTT), Other: iso glycaemic intravenous (iv) glucose infusion (IIGI), Dietary Supplement: Meal test, Other: Incretin effect on sulphonyl urea treatmentAlso called HNF1 alfa MODY. They have a specific mutation in the HNF1 alfa gene. |
| Healthy control subjects | – | Other: Oral Glucose Tolerance Test (OGTT), Other: iso glycaemic intravenous (iv) glucose infusion (IIGI), Dietary Supplement: Meal test, Other: Sitagliptin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Genetically well-charaterized MODY2 and MODY3 patients at Hagedorn Research Institute/Steno Diabetes Center
Key inclusion criteria (6 listed)
- Caucasians above 18 years
- BMI > 19 kg/m2
- Negative pancreatic beta cell- and glutamate decarboxylase-65(GAD65)- autoantibodies
- Normal haemoglobin
- Normal bloodpressure
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Glucose Tolerance Test (OGTT)Also: Waterfree glucose, The Pharmacy of the capital region50g waterfree glucose dissolved in 300ml water consumed over 5 min. | Other | Healthy control subjects, MODY2, MODY3 |
| iso glycaemic intravenous (iv) glucose infusion (IIGI)Also: Glucose infusion, 20%20% glucose | Other | Healthy control subjects, MODY2, MODY3 |
| Meal testAlso: Nutridrink with cocoa taste (Nutricia, Allerød, Denmark)Energy drink, 350ml (525 kcal: 65 g carbohydrates, 20 g fat and 21 g protein) | Dietary supplement | Healthy control subjects, MODY2, MODY3 |
| SitagliptinAlso: Januvia, 100mgHealthy 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 | Healthy control subjects |
| Incretin effect on sulphonyl urea treatmentSubject with MODY who are treated with sulphonyl urea are investigated without medication break prior to examination. | Other | MODY2, MODY3 |
Primary outcome
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.
3 secondary outcomes
Plasma GLP1 response
Time frame: Within 1 year
Plasma GIP response
Time frame: Within 1 year
Plasma glucagon response
Time frame: Within 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2013.
- Derived from this study: PubMed 25953829Ostoft 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.
Related trials for Maturity-onset Diabetes of the Young
Not yet recruiting
Digital Self-Management Education and Support for Young Adults With Type 2 Diabetes (DSMESYAT2DM)
Type 2 Diabetes Mellitus (T2DM), Diabetes-related Distress
Recruiting
Safety Evaluation of MODI, an Insulin Titration Algorithm, in Adults With Diabetes
Type 1 Diabetes (T1D), Type 2 Diabetes (T2D)
Active, not recruiting
The YMCA Healthy Lifestyle Program for Prediabetes
PreDiabetes
Active, not recruitingObservational study
Early Check: Expanded Screening in Newborns
Spinal Muscular Atrophy, Fragile X Syndrome
Not yet recruiting
MoDi Twin Placental Imaging
Monochorionic Diamniotic Placenta, Monochorial Monoamniotic Placenta
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Signe H Østoft, MD, phd stud principal investigator
Diabetes Research Division, University Hospital Gentofte, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maturity-onset Diabetes of the Young, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incretin effect (time frame: Within 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01342939, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2013.