Glucagon Responses During Oral- and iv Glucose in Patients With Type 1 Diabetes

NCT ID: NCT00704795

Last Updated: 2008-06-26

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

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-10-31

Brief Summary

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In order to evaluate the potential role of the gastrointestinal (GI) tract in the postprandial hyperglucagonemia, which characterizes type 1 diabetes mellitus (T1DM) (as well as type 2 diabetes mellitus (T2DM)), we wish to investigate the secretion of glucagon in patients with T1DM without residual beta-cell function during 50-g oral glucose tolerance test (OGTT) and during isoglycemic iv glucose infusion. By evaluating C-peptide negative patients with T1DM we aim to describe the glucagon response to glucose (+/-stimulation of the GI tract) independently of the potentially very important regulation of glucagon secretion by endogenous insulin secretion. A more detailed understanding of the inappropriate glucagon secretion in T1DM is highly needed in order to establish new intervention strategies in the future treatment of the growing numbers of T1DM patients.

Detailed Description

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Conditions

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Hyperglucagonemia Hyperglycemia Diabetes Mellitus

Study Design

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Observational Model Type

CASE_CONTROL

Study Groups

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1

Patients with type 1 diabetes mellitus

Oral glucose tolerance test

Intervention Type OTHER

50 g of waterfree glucose dissolved in 300 ml water is ingested over 5 minutes following a 10-h fast including liquids and medication (if any).

Isoglycemic iv glucose infusion

Intervention Type OTHER

The plasma glucose curve obtained during a 50 g-OGTT (performed on a separate day) is copied using an adjustable iv glucose infusion (20% w/v) performed following a 10-h fast including liquids and medication (if any). The iv catheter is inserted into a peripheral vein in the hand/forearm.

2

Healthy control subjects matched for body mass index (BMI), age and gender.

Oral glucose tolerance test

Intervention Type OTHER

50 g of waterfree glucose dissolved in 300 ml water is ingested over 5 minutes following a 10-h fast including liquids and medication (if any).

Isoglycemic iv glucose infusion

Intervention Type OTHER

The plasma glucose curve obtained during a 50 g-OGTT (performed on a separate day) is copied using an adjustable iv glucose infusion (20% w/v) performed following a 10-h fast including liquids and medication (if any). The iv catheter is inserted into a peripheral vein in the hand/forearm.

Interventions

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Oral glucose tolerance test

50 g of waterfree glucose dissolved in 300 ml water is ingested over 5 minutes following a 10-h fast including liquids and medication (if any).

Intervention Type OTHER

Isoglycemic iv glucose infusion

The plasma glucose curve obtained during a 50 g-OGTT (performed on a separate day) is copied using an adjustable iv glucose infusion (20% w/v) performed following a 10-h fast including liquids and medication (if any). The iv catheter is inserted into a peripheral vein in the hand/forearm.

Intervention Type OTHER

Other Intervention Names

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OGTT 50 g-OGTT Isoglycemic IVGTT

Eligibility Criteria

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Inclusion Criteria

* Caucasian over 18 years with T1DM (diagnosed according to WHO's criteria) treated with long-acting insulin
* No residual beta-cell function (arginine test without increment in plasma C-peptide - see below)
* BMI \<30 kg/m2
* Normal haemoglobin
* Informed consent

Exclusion Criteria

* Residual beta-cell function (increment in plasma C-peptide during arginine test - see below)
* Known liver disease or affected liver enzymes (ALAT/ASAT \> 2 x upper normal limit)
* Diabetic nephropathy (se-creatinin \> 130 µM and/or albuminuria)
* Proliferative diabetic retinopathy (anamnestic)
* Treatment with medication that cannot be discontinued for 14 hours
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 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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Gentofte University Hospital, Copenhagen

Principal Investigators

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Filip K Knop, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Gentofte, Copenhagen

Locations

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Gentofte University Hospital

Hellerup, Hellerup, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-D-2008-037

Identifier Type: -

Identifier Source: org_study_id