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

U

University Hospital, Gentofte, Copenhagen

Status

Completed

Conditions

Type 2 Diabetes Mellitus

Treatments

Biological: isoglycemic intravenous glucose infusion and Glucagon infusion, day C
Biological: intravenous iv glucose infusion, day B
Biological: Oral glucose tolerance test, day A

Study type

Observational

Funder types

Other

Identifiers

NCT02010827
H-4-2013-012

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

35 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

20 participants in 2 patient groups

Patients
Description:
Patients
Treatment:
Biological: intravenous iv glucose infusion, day B
Biological: isoglycemic intravenous glucose infusion and Glucagon infusion, day C
Biological: Oral glucose tolerance test, day A
healthy controls
Description:
healthy controls
Treatment:
Biological: intravenous iv glucose infusion, day B
Biological: isoglycemic intravenous glucose infusion and Glucagon infusion, day C
Biological: Oral glucose tolerance test, day A

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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