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

Not Applicable
Completed
Conditions
Diabetes
Interventions
Biological: Glucagon
Registration Number
NCT02475421
Lead Sponsor
University Hospital, Gentofte, Copenhagen
Brief Summary

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

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
32
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Healthy, lean subjectsGlucagonHealthy subjects with BMI \< 27 kg/m\^2
Healthy, obese subjectsGlucagonHealthy subjects with BMI \> 33 kg/m\^2
Diabetic, lean subjectsGlucagonDiabetic subjects with BMI \< 27 kg/m\^2
Diabetic, obese subjectsGlucagonDiabetic subjects with BMI \> 33 kg/m\^2
Primary Outcome Measures
NameTimeMethod
Metabolic clearance rate of glucagon-30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes
Secondary Outcome Measures
NameTimeMethod
Gut and pancreatic hormones-30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes
Blood glucose-30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes
Basic metabolic rate-30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes
Satiety, hunger, appetite - measured with visual analogue scales (VAS)-30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes
Half life of glucagon-30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes
The volume of distribution of glucagon-30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes

Trial Locations

Locations (1)

Center for Diabetes Research, Department of Medicine, Gentofte Hospital

🇩🇰

Hellerup, Copenhagen, Denmark

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