GIP and GLP-1 in Type 1 Diabetes

NCT ID: NCT01739283

Last Updated: 2015-07-13

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

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-11-30

Brief Summary

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Investigation of Glucose-dependent Insulinotropic Polypeptide (GIP) effects at hyper and hypoglycemia in type 1 diabetes.

Detailed Description

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Conditions

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Hypoglycemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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hyperglycemia

Hyperglycemic clamping

Group Type EXPERIMENTAL

GIP

Intervention Type OTHER

Saline

Intervention Type OTHER

hypoglycemia

Hypoglycemic clamping

Group Type EXPERIMENTAL

GIP

Intervention Type OTHER

GLP-1

Intervention Type OTHER

Saline

Intervention Type OTHER

Interventions

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GIP

Intervention Type OTHER

GLP-1

Intervention Type OTHER

Saline

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

• Diagnosed with type 1 diabetes (WHO criteria)

Exclusion Criteria

* HbA1c \> 9 %
* Liver disease (ALAT/ASAT \> 2 x upper normal limit)
* Diabetic nephropathy (s-creatinine \> 130 µM or albuminuria)
* Proliferative diabetic retinopathy (anamnestic)
* Severe arteriosclerosis or heart failure (NYHA group III or IV)
* Anemia
* treatment with medication not applicable to pause for 12 hours
* C-peptide increase after 50 g iv arginine
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Copenhagen

OTHER

Sponsor Role collaborator

Mikkel Christensen

OTHER

Sponsor Role lead

Responsible Party

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Mikkel Christensen

principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mikkel Christensen, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Gentofte, Copenhagen

Locations

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Gentofte Hospital

Hellerup, , Denmark

Site Status

Countries

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Denmark

References

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Christensen M, Calanna S, Sparre-Ulrich AH, Kristensen PL, Rosenkilde MM, Faber J, Purrello F, van Hall G, Holst JJ, Vilsboll T, Knop FK. Glucose-dependent insulinotropic polypeptide augments glucagon responses to hypoglycemia in type 1 diabetes. Diabetes. 2015 Jan;64(1):72-8. doi: 10.2337/db14-0440. Epub 2014 Jul 22.

Reference Type DERIVED
PMID: 25053587 (View on PubMed)

Other Identifiers

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H-2-2009-078 33269

Identifier Type: -

Identifier Source: org_study_id

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