Glucose-dependent Insulinotropic Polypeptide as a Safeguard Against Hypoglycemia in Patients With Type 1 Diabetes

NCT ID: NCT03556098

Last Updated: 2021-05-10

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-22

Study Completion Date

2020-02-11

Brief Summary

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In the present project the investigators will evaluate whether glucagonotropic properties of the gut-derived incretin hormone glucose-dependent insulinotropic polypeptide (GIP) may be utilized as a safeguard against hypoglycemia in patients with T1D.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Double blinded, randomized, cross-over study
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators
The peptides/placebo is prepared, in a randomized fashion, by a laboratory assistant..

Study Groups

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GIP

Infusion of Glucose-dependent insulinotropic peptide

Group Type ACTIVE_COMPARATOR

glucose-dependent insulinotropic peptide

Intervention Type DRUG

Infusion of GIP

GIP[3-30]

Infusion of GIP\[3-30\]

Group Type ACTIVE_COMPARATOR

Glucose-Dependent Insulin-Releasing Hormone[3-30]

Intervention Type DRUG

Infusion of GIP antagonist GIP\[3-30\]

Saline

Infusion of saline

Group Type PLACEBO_COMPARATOR

Saline Solution

Intervention Type DRUG

Infusion of Saline

Interventions

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glucose-dependent insulinotropic peptide

Infusion of GIP

Intervention Type DRUG

Glucose-Dependent Insulin-Releasing Hormone[3-30]

Infusion of GIP antagonist GIP\[3-30\]

Intervention Type DRUG

Saline Solution

Infusion of Saline

Intervention Type DRUG

Other Intervention Names

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Placebo

Eligibility Criteria

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Inclusion Criteria

* Caucasian men
* Body mass index between 20-27 kg/m\^2
* T1D (diagnosed according to the criteria of the World Health Organization) with HbA1c\<69 mmol/l (\<8,5%)
* T1D duration between 2-20 years
* Stimulated C-peptide ≤ 100 pmol/mL)
* Treatment with a stable basal bolus or insulin pump regimen ≥ 3 months
* Informed consent

Exclusion Criteria

* Anemia (hemoglobin below normal range)
* Liver disease (ALAT and/or ASAT \>2 times normal values) or history of hepatobiliary disorder
* Nephropathy (serum creatinine above normal range and/or albuminuria)
* Allergy or intolerance to ingredients included in the standardized meals
* Prior myocardial infarction or other cardiac events
* Any physical or psychological condition that the investigator fells would interfere with trial participation
* Treatment with any glucose-lowering drugs beside insulin
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Steno Diabetes Center Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Bjørn Hoe

Medical Doctor, PhD student, Prinicipal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Filip K Knop, MD, PhD

Role: STUDY_DIRECTOR

Steno Diabetes Center Copenhagen, Clinical Metabolic Physiology

Locations

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Steno Diabetes Center Copenhagen, Clinical Metabolic Physiology

Hellerup, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-18002707

Identifier Type: -

Identifier Source: org_study_id

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