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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 hormones

Blood 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

Page last updated: August 23, 2015

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