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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02475421
Acronym
MCR Glucagon
Enrollment
32
Registered
2015-06-18
Start date
2015-05-31
Completion date
2017-01-31
Last updated
2018-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Keywords

Diabetes, Glucagon, Metabolic clearance rate of glucagon

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.

Interventions

BIOLOGICALGlucagon

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

Sponsors

University of Copenhagen
CollaboratorOTHER
European Foundation for the Study of Diabetes
CollaboratorOTHER
University Hospital, Gentofte, Copenhagen
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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
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
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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026