GIP and GLP-1 on Gastric Emptying, Appetite and Insulin-glucose

NCT ID: NCT01079624

Last Updated: 2010-03-03

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

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2009-11-30

Brief Summary

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Academic phase 1 study which investigates the effects of the two incretin hormones glucose-insulinotropic peptide (GIP) and glucagon-like peptide-1 (GLP-1) on gastric emptying, appetite, insulin release and glucose disposal in the body. The hypothesis is that incretin hormones not only stimulate insulin release but also inhibits gastric emptying. This effect can be utilized for further drug development.

Detailed Description

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Effects of GIP and GLP-1 on gastric emptying, appetite control and insulin release in relation to glucose levels in the bloodstream. Infusions of GIP and GLP-1 are given under simultaneous gastric emptying study and appetite questionnaires and blood sampling for analysis of insulin, glucose, and other gut hormones such as glucagon, ghrelin, and PYY, as well as those administered, GIP and GLP-1.

Conditions

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Physiology Gastroenterology Endocrinology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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GIP two doses and GLP-1 one dose

Intervention with infusion of GIP or GLP-1 intravenously

Group Type EXPERIMENTAL

Glucose-insulinotropic peptide, Glucagon-like peptide-1

Intervention Type OTHER

GIP 2 and 5 pmol/kg min GLP-1 0.7 pmol/kg min

Saline infusion

Control

Group Type PLACEBO_COMPARATOR

Glucose-insulinotropic peptide, Glucagon-like peptide-1

Intervention Type OTHER

GIP 2 and 5 pmol/kg min GLP-1 0.7 pmol/kg min

Interventions

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Glucose-insulinotropic peptide, Glucagon-like peptide-1

GIP 2 and 5 pmol/kg min GLP-1 0.7 pmol/kg min

Intervention Type OTHER

Other Intervention Names

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GIP GLP-1 Saline

Eligibility Criteria

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Inclusion Criteria

* Men and women
* 18-50 years old;
* otherwise healthy and HIV and HCB, HCV negative

Exclusion Criteria

* Age \>50,
* all types of diseases and drug users.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role collaborator

Uppsala University

OTHER

Sponsor Role lead

Responsible Party

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Uppsala University

Principal Investigators

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Per M Hellstrom, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet, Uppsala University

Locations

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Karolinska University Hospital

Stockholm, Stockholm County, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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K2010-55X -07916-24-3

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

GIP/GLP-gastric empt-APP-hor

Identifier Type: -

Identifier Source: org_study_id

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