The Role of Glucose-Dependent Insulinotropic Polypeptide in the Pathological Glucose Homeostasis Of Type 1 Diabetes

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 the daily life of participants with type 1 Diabetes

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT03556098

Diabetes Mellitus, Type 1

COMPLETED NA

The Effects of GIP and GLP-2 on the Secretion of Glucagon in Patients With Type 1 Diabetes

NCT00732602

Diabetes Mellitus

COMPLETED NA

GIP Effects at Insulin Induced Hypoglycemia in Patients With Type 2 Diabetes

NCT01414556

Type 2 Diabetes Mellitus

COMPLETED EARLY_PHASE1

Glucose-dependent Insulinotropic Polypeptide - New Role as Blood Glucose Stabilizer?

NCT01048268

Diabetes Mellitus

COMPLETED PHASE1/PHASE2

Insulinotropic Effect of GIP and GLP-1 Before and After Reduced Glucose Tolerance

NCT01173978

Insulin Resistance Deteriorated Glucose Homeostasis Inactivity

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 1 Hypoglycemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

placebo-controlled, double-blinded, cross-over study

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Glucose-Dependent Insulinotropic Polypeptide

6-day continuous infusion of Glucose-Dependent Insulinotropic Polypeptide

Group Type ACTIVE_COMPARATOR

GIP

Intervention Type DRUG

Infusion of Glucose-dependent insulinotropic peptide

Placebo

Saline

Group Type PLACEBO_COMPARATOR

GIP

Intervention Type DRUG

Infusion of Glucose-dependent insulinotropic peptide

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GIP

Infusion of Glucose-dependent insulinotropic peptide

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Body mass index between 20 and 27 kg/m2
* T1D (diagnosed according to the criteria of the World Health Organization) with HbA1c \<69 mmol/mol (\<8.5%)
* Treatment with a stable insulin regimen ≥3 months
* T1D duration between 2 and 15years
* C-peptide negative (C-peptide ≤ 16 ng/ml)
* Informed consent

Exclusion Criteria

* Anemia (hemoglobin outside normal range)
* Known liver disease and/or ALAT and/or ASAT \> 2 times normal values
* Estimated glomerular filtration rate (eGFR) ≤60 ml/min/1.73 m2 or albuminuria
* Prior Cardiovascular events and/or abnormal heart rate/blood pressure
* Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to randomization
* Any physical or psychological condition that the investigator feels would interfere with trial participation

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No