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

Condition(s) targeted: Type 2 Diabetes Mellitus

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

Phase: N/A

Status: Active, not recruiting

Sponsored by: University Hospital, Gentofte, Copenhagen

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.

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

Study design: Observational Model: Case Control, Time Perspective: Prospective

Primary outcome: Differences in Endogenous glucose production during the three days measured as total Area under the curve (tAUC)

Secondary outcome:

Differences in glucagon during the three days measured as total Area under the curve (tAUC)

Differences in incretin hormone levels during the three days measured as total Area under the curve (tAUC)

Differences in gastrointestinal hormones during the three days measured as total Area under the curve (tAUC)

differences in appetite, hunger, satiety between the three days

Detailed 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.

Minimum age: 35 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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

Diabetes Research Division, University Hospital Gentofte, Hellerup 2900, Denmark

Starting date: November 2013
Last updated: June 11, 2015