Hyperglucagonaemia in Patients With Type 2 Diabetes - Role of Glucagon Clearance
Information source: University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes
Intervention: Glucagon (Biological)
Phase: N/A
Status: Recruiting
Sponsored by: University Hospital, Gentofte, Copenhagen Overall contact: Asger Lund, MD, Email: Lund.asger@gmail.com
Summary
The study aims to evaluate the elimination and degradation of glucagon in patients with type
2 diabetes compared to matched healthy subjects.
Clinical Details
Official title: Hyperglucagonaemia in Patients With Type 2 Diabetes - Role of Glucagon Clearance
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Metabolic clearance rate of glucagon
Secondary outcome: Gut and pancreatic hormonesBlood glucose Basic metabolic rate Satiety, hunger, appetite - measured with visual analogue scales (VAS) Half life and volume of distribution of glucagon
Detailed description:
In the present project we wish to identify whether the elimination and degradation of
glucagon differ between healthy control subjects and patients with type 2 diabetes.
Furthermore, we 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 we 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Asger Lund, MD, Email: Lund.asger@gmail.com
Center for Diabetes Research, Department of Medicine, Gentofte Hospital, Hellerup, Copenhagen 2900, Denmark; Recruiting Asger Lund, MD, Email: Lund.asger@gmail.com Magnus Grøndahl, Med. student, Phone: 004529362445, Email: Magnusgroendahl@gmail.com Asger Lund, MD, Principal Investigator Magnus Grøndahl, Med. student, Sub-Investigator
Additional Information
Starting date: May 2015
Last updated: June 17, 2015
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