Clinical trial NCT02475421: Hyperglucagonaemia in Patients With Type 2 Diabetes - Role of Glucagon Clearance
Official title: Hyperglucagonaemia in Patients With Type 2 Diabetes - Role of Glucagon Clearance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Diabetes
Glucagon
Metabolic clearance rate of glucagon
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: European Foundation for the Study of Diabetes
First posted: 2015-06-18
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Metabolic clearance rate of glucagon
timeFrame: -30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes
Secondary outcomes:
measure: Gut and pancreatic hormones
timeFrame: -30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes
measure: Blood glucose
timeFrame: -30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes
measure: Basic metabolic rate
timeFrame: -30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes
measure: Satiety, hunger, appetite - measured with visual analogue scales (VAS)
timeFrame: -30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes
measure: Half life of glucagon
timeFrame: -30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes
measure: The volume of distribution of glucagon
timeFrame: -30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Center for Diabetes Research, Department of Medicine, Gentofte Hospital
state: Copenhagen
Study officials:
References: