Endogenous Glucoseproduction in Patients With Type 2 Diabetes Mellitus During Oral Glucose and iv. Glucose Infusion

Type 2 Diabetes Mellitus Clinical Trial

— EGP_Glucagon  

Official title:

Endogenous Glucoseproduction in Patients With Type 2 Diabetes Mellitus During Oral Glucose and iv. Glucose Infusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02010827
• Other study ID #: H-4-2013-012
• Status: Completed
• Phase: N/A
• First received: November 27, 2013
• Last updated: November 30, 2015
• Start date: November 2013
• Est. completion date: August 2015

Study information

• Verified date: November 2015
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of HelathDenmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial Summary

We want to investigate how lack of glucagon suppression during an oral glucose tolerance test in patients with type 2 diabetes contributes to patients postprandial hyperglycemia.

Description:

Patients with type 2 diabetes mellitus (T2DM) are not able to suppress their glucagon secretion after a meal or after ingestion of glucose. Previous studies have shown that gastrointestinal hormones might play a role in this phenomenon. However, it has not yet been possible to determine whether this lack of glucagon suppression postprandially results in an increased endogenous glucose secretion, and thus is a factor in the patients postprandial hyperglycemia.

We aim to perform oral glucose tolerance tests and isoglycemic intravenous glucose infusions with and without a continuous glucagon infusion in patients with T2DM and healthy control subjects. The glucagon infusion is aiming at copying the inappropriate "physiological" glucagon response observed in patients with T2DM.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 80 Years

Eligibility

Inclusion Criteria:

Patients with T2DM

• Caucasions above 35 years of age with diet and/or tablettreated T2DM of at -least three months (diagnosis acording to WHO)

• Normal haemoglobin

• Informed consent

Healthy Subjects

• Normal fasting plasma glucose (FPG) and normal HbA1C (according to the -World Health Organization (WHO) criteria)

• Normal haemoglobin

• Age above 35 years

• Informed consent

Exclusion Criteria:

• Inflammatory bowel disease

• Nephropathy (serum creatinine >150 µM and/or albuminuria)

• Severe liver disease (serum alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) >3×normal values)

• Pregnancy and/or breastfeeding

• Age above 80 years

• Any condition that the investigator feels would interfere with trial participation

Patients with T2DM

Healthy Subjects

• Diabetes mellitus (DM)

• Prediabetes (impaired glucose tolerance and/or impaired FPG)

• First degree relatives with DM

• Inflammatory bowel disease

• Intestinal resection and/or ostomy

• Nephropathy (serum creatinine >150 µM and/or albuminuria

• Liver disease (ALAT and/or serum ASAT >2×normal values)

• Pregnancy and/or breastfeeding

• Age above 80 years

• Any condition that the investigator feels would interfere with trial participation

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Biological:
• isoglycemic intravenous glucose infusion and Glucagon infusion, day C
Infusion of 0.8ng/kg/min glucagon from time 0-25min
• Oral glucose tolerance test, day A

• intravenous iv glucose infusion, day B

Locations

Country	Name	City	State
Denmark	Diabetes Research Division, University Hospital Gentofte	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in Endogenous glucose production during the three days measured as total Area under the curve (tAUC)	calculated based on infusions of stable isotope marked glucose	Endogenous glucose production will be calculated based on blood samples at time points: -30,-15,0,10,20,30,50,70,90,120,150,180 and 240 min on all days.	No
Secondary	Differences in glucagon during the three days measured as total Area under the curve (tAUC)		Glucagon will be measured at time points: -30,-15,0,10,20,30,50,70,90,120,150,180 and 240 min on all days.	No
Secondary	Differences in incretin hormone levels during the three days measured as total Area under the curve (tAUC)	GIP and GLP-1	incretin hormone levels will be measured at time points: -30,-15,0,10,20,30,50,70,90,120,150,180, 240 min on all days.	No
Secondary	Differences in gastrointestinal hormones during the three days measured as total Area under the curve (tAUC)		At the end of the study	No
Secondary	differences in appetite, hunger, satiety between the three days	Will be measured with visual analogue scales (VAS)	Satiety, hunger and appetite will be measured at time points:0,30,60,90,120,150,180, 240 min during each day.	No