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Completed

NCT Number: NCT02010827

Endogenous Glucoseproduction in Patients With Type 2 Diabetes Mellitus During Oral Glucose and iv. Glucose Infusion

We want to investigate how lack of glucagon suppression during an oral glucose tolerance test in patients with type 2 diabetes contributes to patients postprandial hyperglycemia.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Diabetes Research Division, University Hospital Gentofte

Hellerup, 2900, Denmark

About this study

Patients with type 2 diabetes mellitus (T2DM) are not able to suppress their glucagon secretion after a meal or after ingestion of glucose. Previous studies have shown that gastrointestinal hormones might play a role in this phenomenon. However, it has not yet been possible to determine whether this lack of glucagon suppression postprandially results in an increased endogenous glucose secretion, and thus is a factor in the patients postprandial hyperglycemia.

We aim to perform oral glucose tolerance tests and isoglycemic intravenous glucose infusions with and without a continuous glucagon infusion in patients with T2DM and healthy control subjects. The glucagon infusion is aiming at copying the inappropriate "physiological" glucagon response observed in patients with T2DM.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Patients with T2DM

  • Caucasions above 35 years of age with diet and/or tablettreated T2DM of at -least three months (diagnosis acording to WHO)
  • Normal haemoglobin
  • Informed consent

Healthy Subjects

  • Normal fasting plasma glucose (FPG) and normal HbA1C (according to the -World Health Organization (WHO) criteria)
  • Normal haemoglobin
  • Age above 35 years
  • Informed consent

Exclusion criteria

  • Inflammatory bowel disease
  • Nephropathy (serum creatinine >150 µM and/or albuminuria)
  • Severe liver disease (serum alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) >3×normal values)
  • Pregnancy and/or breastfeeding
  • Age above 80 years
  • Any condition that the investigator feels would interfere with trial participation

Patients with T2DM

Healthy Subjects

  • Diabetes mellitus (DM)
  • Prediabetes (impaired glucose tolerance and/or impaired FPG)
  • First degree relatives with DM
  • Inflammatory bowel disease
  • Intestinal resection and/or ostomy
  • Nephropathy (serum creatinine >150 µM and/or albuminuria
  • Liver disease (ALAT and/or serum ASAT >2×normal values)
  • Pregnancy and/or breastfeeding
  • Age above 80 years
  • Any condition that the investigator feels would interfere with trial participation

Treatment and study plan

isoglycemic intravenous glucose infusion and Glucagon infusion, day C

Biological

Infusion of 0.8ng/kg/min glucagon from time 0-25min

Oral glucose tolerance test, day A

Biological

intravenous iv glucose infusion, day B

Biological

Primary outcomes

  1. Differences in Endogenous glucose production during the three days measured as total Area under the curve (tAUC)

    Time frame: Endogenous glucose production will be calculated based on blood samples at time points: -30,-15,0,10,20,30,50,70,90,120,150,180 and 240 min on all days.

    calculated based on infusions of stable isotope marked glucose

Secondary outcomes

  1. Differences in glucagon during the three days measured as total Area under the curve (tAUC)

    Time frame: Glucagon will be measured at time points: -30,-15,0,10,20,30,50,70,90,120,150,180 and 240 min on all days.

  2. Differences in incretin hormone levels during the three days measured as total Area under the curve (tAUC)

    Time frame: incretin hormone levels will be measured at time points: -30,-15,0,10,20,30,50,70,90,120,150,180, 240 min on all days.

    GIP and GLP-1

  3. Differences in gastrointestinal hormones during the three days measured as total Area under the curve (tAUC)

    Time frame: At the end of the study

  4. differences in appetite, hunger, satiety between the three days

    Time frame: Satiety, hunger and appetite will be measured at time points:0,30,60,90,120,150,180, 240 min during each day.

    Will be measured with visual analogue scales (VAS)

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Registry information

Acronym: EGP_Glucagon

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Dec 13, 2013
Registry last updated
Dec 2, 2015

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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