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

NCT ID: NCT02475421

Last Updated: 2018-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Healthy, lean subjects

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

Group Type EXPERIMENTAL

Glucagon

Intervention Type BIOLOGICAL

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

Healthy, obese subjects

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

Group Type EXPERIMENTAL

Glucagon

Intervention Type BIOLOGICAL

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

Diabetic, lean subjects

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

Group Type EXPERIMENTAL

Glucagon

Intervention Type BIOLOGICAL

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

Diabetic, obese subjects

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

Group Type EXPERIMENTAL

Glucagon

Intervention Type BIOLOGICAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Glucagon

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

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Copenhagen

OTHER

Sponsor Role collaborator

European Foundation for the Study of Diabetes

OTHER

Sponsor Role collaborator

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Asger Lund

Asger Lund, MD, PhD-student, University Hospital, Gentofte, Copenhagen

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Center for Diabetes Research, Department of Medicine, Gentofte Hospital

Hellerup, Copenhagen, Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H-1-2014-066

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.