NCT02475421

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 11, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 18, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

October 15, 2018

Status Verified

October 1, 2018

Enrollment Period

1.6 years

First QC Date

June 11, 2015

Last Update Submit

October 10, 2018

Conditions

Diabetes

Keywords

DiabetesGlucagonMetabolic clearance rate of glucagon

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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

  • 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

  • Half life of glucagon

    -30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes

  • +1 more secondary outcomes

Study Arms (4)

Healthy, lean subjects

EXPERIMENTAL

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

Biological: Glucagon

Healthy, obese subjects

EXPERIMENTAL

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

Biological: Glucagon

Diabetic, lean subjects

EXPERIMENTAL

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

Biological: Glucagon

Diabetic, obese subjects

EXPERIMENTAL

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

Biological: Glucagon

Interventions

GlucagonBIOLOGICAL

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

Diabetic, lean subjectsDiabetic, obese subjectsHealthy, lean subjectsHealthy, obese subjects

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Diabetes Research, Department of Medicine, Gentofte Hospital

Hellerup, Copenhagen, 2900, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Glucagon

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ProglucagonPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asger Lund, MD, PhD-student, University Hospital, Gentofte, Copenhagen

Study Record Dates

First Submitted

June 11, 2015

First Posted

June 18, 2015

Study Start

May 1, 2015

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

October 15, 2018

Record last verified: 2018-10

Locations

DK(1)