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

NCT ID: NCT02010827

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

Patients

isoglycemic intravenous glucose infusion and Glucagon infusion, day C

Intervention Type BIOLOGICAL

Infusion of 0.8ng/kg/min glucagon from time 0-25min

Oral glucose tolerance test, day A

Intervention Type BIOLOGICAL

intravenous iv glucose infusion, day B

Intervention Type BIOLOGICAL

healthy controls

healthy controls

isoglycemic intravenous glucose infusion and Glucagon infusion, day C

Intervention Type BIOLOGICAL

Infusion of 0.8ng/kg/min glucagon from time 0-25min

Oral glucose tolerance test, day A

Intervention Type BIOLOGICAL

intravenous iv glucose infusion, day B

Intervention Type BIOLOGICAL

Interventions

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isoglycemic intravenous glucose infusion and Glucagon infusion, day C

Infusion of 0.8ng/kg/min glucagon from time 0-25min

Intervention Type BIOLOGICAL

Oral glucose tolerance test, day A

Intervention Type BIOLOGICAL

intravenous iv glucose infusion, day B

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Asger Lund

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Diabetes Research Division, University Hospital Gentofte

Hellerup, , Denmark

Site Status

Countries

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Denmark

References

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Lund A, Bagger JI, Christensen M, Grondahl M, van Hall G, Holst JJ, Vilsboll T, Knop FK. Higher Endogenous Glucose Production During OGTT vs Isoglycemic Intravenous Glucose Infusion. J Clin Endocrinol Metab. 2016 Nov;101(11):4377-4384. doi: 10.1210/jc.2016-1948. Epub 2016 Aug 17.

Reference Type DERIVED
PMID: 27533305 (View on PubMed)

Other Identifiers

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H-4-2013-012

Identifier Type: -

Identifier Source: org_study_id