Effect of GLP-1 and GIP on Insulin Secretion in Type-1 Diabetes Mellitus

NCT ID: NCT00603031

Last Updated: 2011-01-21

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

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-06-30

Brief Summary

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study hypothesis: treatment with GLP-1 and/or GIP is able to potentiate the maximal stimulated insulin secretion even in c-peptide negative type-1 diabetic patients classified as having no residual beta cell function left.

Detailed Description

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Conditions

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Type-1 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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GLP-1

time -30-90 min: Continuous infusion with GLP-1 (1,2pmol/kg/min) time 0-90 min:hyperglycemic clamp(20mmol/L) time 45 min:infusion of L-Arginine (5g).

Group Type EXPERIMENTAL

glucagon like peptide -1

Intervention Type OTHER

continuous infusion 1,2 pmol pr. kg pr minute at 120 minutes

NaCl

time -30-90 min: Continuous infusion with NaCl time 0-90 min:hyperglycemic clamp(20mmol/L) time 45 min:infusion of L-Arginine (5g).

Group Type PLACEBO_COMPARATOR

NaCl

Intervention Type OTHER

infusion with NaCl for 120 minutes as placebo-arm

GIP

time -30-90 min: Continuous infusion with GIP-1 (3,6pmol/kg/min) time 0-90 min:hyperglycemic clamp(20mmol/L) time 45 min:infusion of L-Arginine (5g).

Group Type EXPERIMENTAL

glucose dependent insulinotropic polypeptide

Intervention Type OTHER

continuous infusion with GIP-1 (3,6pmol/kg/min) at 120 minutes.

Interventions

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glucagon like peptide -1

continuous infusion 1,2 pmol pr. kg pr minute at 120 minutes

Intervention Type OTHER

NaCl

infusion with NaCl for 120 minutes as placebo-arm

Intervention Type OTHER

glucose dependent insulinotropic polypeptide

continuous infusion with GIP-1 (3,6pmol/kg/min) at 120 minutes.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age 18-60 years
* Type-1 diabetes diagnosed between 5-40 years of age
* Normal weight(BMI 18-27),
* Insulin treatment from time of diagnosis.

Exclusion Criteria

* Severe complications to diabetes
* Abnormal liver or kidney function
* Haemoglobin below the lower limit
* Macroalbuminuria
* Systemic disease
* Pregnancy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Urd Kielgast, MD

Principal Investigators

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Urd Kielgast, MD

Role: PRINCIPAL_INVESTIGATOR

unafilliated

Locations

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Dept. of Endocrinology, Hvidovre Hospital

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2008-000305-11

Identifier Type: OTHER

Identifier Source: secondary_id

H-D-2007-0076

Identifier Type: -

Identifier Source: org_study_id

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