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

Diabetes Clinical Trial

— MCR Glucagon  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02475421
• Other study ID #: H-1-2014-066
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: January 2017

Study information

• Verified date: October 2018
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Biological:
• Glucagon
One hour glucagon-clamp followed by one hour of blood sampling

Locations

Country	Name	City	State
Denmark	Center for Diabetes Research, Department of Medicine, Gentofte Hospital	Hellerup	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen	European Foundation for the Study of Diabetes, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Gut and pancreatic hormones		-30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes
Secondary	Blood glucose		-30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes
Secondary	Basic metabolic rate		-30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes
Secondary	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
Secondary	Half life of glucagon		-30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes
Secondary	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