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Completed

NCT Number: NCT02475421

Hyperglucagonaemia in Patients With Type 2 Diabetes - Role of Glucagon Clearance

The study aims to evaluate the elimination and degradation of glucagon in patients with type 2 diabetes compared to matched healthy subjects.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Diabetes Research, Department of Medicine, Gentofte Hospital

Hellerup, Copenhagen, 2900, Denmark

About this study

In the present project the investigators wish to identify whether the elimination and degradation of glucagon differ between healthy control subjects and patients with type 2 diabetes. Furthermore, the investigators wish to examine whether obesity is an independent factor for altered glucagon metabolism. Thus, by examining glucagon elimination in obese subjects with and without type 2 diabetes and in lean subjects with and without type 2 diabetes the investigators will be able to describe the metabolic clearance rate (MCR) of glucagon in a broad spectrum of individuals with different levels of insulin resistance and beta cell dysfunction.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Patients with type 2 diabetes

  • Caucasians above 35 years of age with diet or/and metformin-treated type 2 diabetes of at least 3 month duration (diagnosed according to World Health Organization (WHO) criteria
  • BMI either below 27 or above 33 kg/m^2
  • Normal haemoglobin
  • Informed consent

Subjects with NGT

  • Caucasians above 35 years of age
  • BMI either below 27 or above 33 kg/m^2
  • Normal HbA1c (according to WHO criteria)
  • Normal haemoglobin
  • Informed consent

Exclusion criteria

Patients with type 2 diabetes

  • Inflammatory bowel disease
  • Operation within the last 3 months
  • Severe kidney disease (eGFR < 60 ml/min)
  • Severe liver disease (serum alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) >2×normal values)
  • Pregnancy and/or breastfeeding
  • Age above 80 years
  • Any condition that the investigators feel would interfere with trial participation

Subjects with NGT

  • Diabetes
  • Prediabetes (impaired FPG or HbA1c above 42 mmol/mol)
  • First-degree relatives with diabetes
  • Inflammatory bowel disease
  • Intestinal resection
  • Severe kidney disease (eGFR < 60 ml/min)
  • Liver disease (ALA T and/or serum ASA T >2×normal values)
  • Pregnancy and/or breastfeeding
  • Age above 80 years Any condition that the investigators feel would interfere with trial participation

Treatment and study plan

Glucagon

Biological

One hour glucagon-clamp followed by one hour of blood sampling

Primary outcomes

  1. Metabolic clearance rate of glucagon

    Time frame: -30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes

Secondary outcomes

  1. Gut and pancreatic hormones

    Time frame: -30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes

  2. Blood glucose

    Time frame: -30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes

  3. Basic metabolic rate

    Time frame: -30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes

  4. Satiety, hunger, appetite - measured with visual analogue scales (VAS)

    Time frame: -30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes

  5. Half life of glucagon

    Time frame: -30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes

  6. The volume of distribution of glucagon

    Time frame: -30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Collaborators

  • European Foundation for the Study of Diabetes
  • University of Copenhagen

Registry information

Acronym: MCR Glucagon

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jun 18, 2015
Registry last updated
Oct 15, 2018

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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