Intact Liver Innervation and Glucose and Glucagon-like Peptide-1 (GLP-1) Induced Insulin Secretion

NCT ID: NCT01176708

Last Updated: 2012-01-06

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

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2012-12-31

Brief Summary

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The aim of the study is to investigate the significance of intact nerve supply to the liver for the glucagon-like peptide-1 (GLP-1) induced insulin secretion.

The hypothesis is that the effects of GLP-1 is transmitted through the GLP-1 receptor and that these effects involve sensory afferent neurons, probably primarily parasympathetic.

Detailed Description

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GLP-1 is a potent enterogastron and incretin hormone. It is rapidly inactivated by dipeptidyl peptidase IV so only 10-15% enters the systemic circulation. This has led to the hypothesis that GLP-1 interact locally with afferent sensory nerve fibers.

The aim of this study is to investigate the significance of intact liver innervation for the GLP-1 induced insulin secretion in liver transplanted patients; kidney transplanted control patients matched for immunosuppressive treatment, age, gender and body weight; and ten control persons matched for age, gender and body weight.

The insulin secretion will be evaluated from blood samples that will be analyzed for insulin and c-peptide.

Conditions

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Liver Transplantation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Liver transplanted

10 Liver transplanted patients

Group Type EXPERIMENTAL

dipeptidyl peptidase 4 (DPP4) inhibitor

Intervention Type DRUG

One tablet (50 mg)of DPP4 inhibitor is to be taken 12 and 1 hours before start of the oral glucose tolerance test (50 g glucose and 1.5 g paracetamol dissolved in 300 ml water)on day 3

oral glucose

Intervention Type OTHER

50 grams glucose dissolved in 300 ml water with 1.5 grams paracetamol

intravenous glucose

Intervention Type OTHER

1.5 g paracetamol dissolved in 50 ml water is to be ingested orally within the first 2 minutes. Intravenous glucose is supplied in an amount to match the plasma glucose during the oral glucose tolerance test

Kidney transplanted

10 kidney transplanted individuals

Group Type EXPERIMENTAL

dipeptidyl peptidase 4 (DPP4) inhibitor

Intervention Type DRUG

One tablet (50 mg)of DPP4 inhibitor is to be taken 12 and 1 hours before start of the oral glucose tolerance test (50 g glucose and 1.5 g paracetamol dissolved in 300 ml water)on day 3

oral glucose

Intervention Type OTHER

50 grams glucose dissolved in 300 ml water with 1.5 grams paracetamol

intravenous glucose

Intervention Type OTHER

1.5 g paracetamol dissolved in 50 ml water is to be ingested orally within the first 2 minutes. Intravenous glucose is supplied in an amount to match the plasma glucose during the oral glucose tolerance test

Healthy controls

10 healthy controls

Group Type EXPERIMENTAL

dipeptidyl peptidase 4 (DPP4) inhibitor

Intervention Type DRUG

One tablet (50 mg)of DPP4 inhibitor is to be taken 12 and 1 hours before start of the oral glucose tolerance test (50 g glucose and 1.5 g paracetamol dissolved in 300 ml water)on day 3

oral glucose

Intervention Type OTHER

50 grams glucose dissolved in 300 ml water with 1.5 grams paracetamol

intravenous glucose

Intervention Type OTHER

1.5 g paracetamol dissolved in 50 ml water is to be ingested orally within the first 2 minutes. Intravenous glucose is supplied in an amount to match the plasma glucose during the oral glucose tolerance test

Interventions

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dipeptidyl peptidase 4 (DPP4) inhibitor

One tablet (50 mg)of DPP4 inhibitor is to be taken 12 and 1 hours before start of the oral glucose tolerance test (50 g glucose and 1.5 g paracetamol dissolved in 300 ml water)on day 3

Intervention Type DRUG

oral glucose

50 grams glucose dissolved in 300 ml water with 1.5 grams paracetamol

Intervention Type OTHER

intravenous glucose

1.5 g paracetamol dissolved in 50 ml water is to be ingested orally within the first 2 minutes. Intravenous glucose is supplied in an amount to match the plasma glucose during the oral glucose tolerance test

Intervention Type OTHER

Other Intervention Names

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Galvus Panodil Panodil

Eligibility Criteria

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Inclusion Criteria

* normal fasting plasma glucose
* normal hemoglobin
* informed consent

Exclusion Criteria

* type 1 diabetes mellitus or type 2 diabetes mellitus
* body mass index \> 30
* inflammatory bowel disease
* intestinal surgery
* serum creatinine \> 250 µM and/or albuminuria
* ALAT \> 2 x normal value
* Severe cardiac insufficiency
* in treatment with medicine which cannot be paused for 12 hours
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Copenhagen

OTHER

Sponsor Role collaborator

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Jonatan I Bagger

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Internal Medicine F' laboratory

Hellerup, Copenhagen, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Astrid Plamboeck, M.D.

Role: CONTACT

+45 26208174

Facility Contacts

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Astrid Plamboeck, M.D.

Role: primary

+45 26208174

Tina Vilsbøll, M.D.

Role: backup

+45 39772461

Other Identifiers

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Transplant isoglycemia (AP)

Identifier Type: -

Identifier Source: org_study_id

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