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

University Hospital, Gentofte, Copenhagen

Status: Completed

Conditions: Diabetes

Treatments: Biological: Glucagon

Study type: Interventional

Funder types: Other

Identifiers

NCT02475421

H-1-2014-066

Details and patient eligibility

About

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

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

32 participants in 4 patient groups

Healthy, lean subjects

Experimental group

Description:

Healthy subjects with BMI \< 27 kg/m\^2

Treatment:

Biological: Glucagon

Healthy, obese subjects

Experimental group

Description:

Healthy subjects with BMI \> 33 kg/m\^2

Treatment:

Biological: Glucagon

Diabetic, lean subjects

Experimental group

Description:

Diabetic subjects with BMI \< 27 kg/m\^2

Treatment:

Biological: Glucagon

Diabetic, obese subjects

Experimental group

Description:

Diabetic subjects with BMI \> 33 kg/m\^2

Treatment:

Biological: Glucagon