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Completed

NCT Number: NCT01342939

Pathophysiological Implications of the Incretin Hormones in Maturity Onset of 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.

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Key information

Conditions

Maturity-onset Diabetes of the Young Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Mason-Type Diabetes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Hellerup, 2900, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oral glucose tolerance test (OGTT)

Other

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

Other names: Waterfree glucose, The Pharmacy of the capital region

iso glycaemic intravenous (iv) glucose infusion (IIGI)

Other

20% glucose

Other names: Glucose infusion, 20%

Meal test

Dietary Supplement

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

Other names: Nutridrink with cocoa taste (Nutricia, Allerød, Denmark)

Sitagliptin

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

Other names: Januvia, 100mg

Incretin effect on sulphonyl urea treatment

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Plasma GLP1 response

    Time frame: Within 1 year

    Comparing GLP1 responses of the different experimental days, compared to healthy control subjects.

  2. Plasma GIP response

    Time frame: Within 1 year

    Comparing GIP responses of the different experimental days, compared to healthy control subjects.

  3. Plasma glucagon response

    Time frame: Within 1 year

    Comparing glucagon responses of the different experimental days, compared to healthy control subjects.

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Collaborators

  • Steno Diabetes Center Copenhagen
  • University of Copenhagen

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 27, 2011
Registry last updated
Jan 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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