Beta-Cell Function After Near-Normalisation of Blood Glucose

NCT ID: NCT00612950

Last Updated: 2008-02-12

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

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-05-31

Brief Summary

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The incretin effect is attenuated in patients with type 2 diabetes mellitus partly due to impaired potentiation of beta-cell responsiveness to glucose by glucose dependent insulinotropic polypeptide and glucagon-like peptide-1 respectively. The aim of the present study was to investigate whether 4 weeks of near-normalization of blood glucose could improve the insulin responses to GIP and GLP-1 in patients with type 2 diabetes.

Detailed Description

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Conditions

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Type 2 Diabetes

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

Group Type EXPERIMENTAL

glucagon-like peptide-1,

Intervention Type DRUG

GLP-1:continuous infusion of ½ pmol/kg/min for a total time of 120 minutes.

GIP

Group Type EXPERIMENTAL

glucose dependent insulinotropic polypeptide

Intervention Type DRUG

continuous infusion of GIP (1½ pmol/kg/min) for 120 min.

saline

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

continuous infusion of Saline for 120 min

Interventions

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glucagon-like peptide-1,

GLP-1:continuous infusion of ½ pmol/kg/min for a total time of 120 minutes.

Intervention Type DRUG

glucose dependent insulinotropic polypeptide

continuous infusion of GIP (1½ pmol/kg/min) for 120 min.

Intervention Type DRUG

Saline

continuous infusion of Saline for 120 min

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 18-70 years
* Type 2 diabetes diagnosed after 30 years of age
* BMI \> 25

Exclusion Criteria

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

18 Years

Maximum Eligible Age

70 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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Kettegaard Alle 30, 2650 Hvidovre

Principal Investigators

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Patricia V Højberg, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Hvidovre

Locations

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Dept. of Endocrinology, Hvidovre Hospital

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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Hojberg PV, Vilsboll T, Rabol R, Knop FK, Bache M, Krarup T, Holst JJ, Madsbad S. Four weeks of near-normalisation of blood glucose improves the insulin response to glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide in patients with type 2 diabetes. Diabetologia. 2009 Feb;52(2):199-207. doi: 10.1007/s00125-008-1195-5. Epub 2008 Nov 27.

Reference Type DERIVED
PMID: 19037628 (View on PubMed)

Other Identifiers

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KA 03005

Identifier Type: -

Identifier Source: secondary_id

KA 03005

Identifier Type: -

Identifier Source: org_study_id

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