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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 1; Hypoglycemia
• Interventions: Drug: GIP

• Registration Number: NCT03734718
• Lead Sponsor: Steno Diabetes Center Copenhagen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-22
• Study First Submitted QC: 2018-11-06
• Study First Posted: 2018-11-08
• Study Start: 2019-06-01
• Primary Completion: 2019-12-12
• Study Completion: 2019-12-31
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-23
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Glucose-Dependent Insulinotropic Polypeptide	GIP	6-day continuous infusion of Glucose-Dependent Insulinotropic Polypeptide
Placebo	GIP	Saline

Primary Outcome Measures

Name	Time	Method
Blood glucose	an average of 6 days	Time spent in hypoglycemia, near-normoglycemia and hyperglycemia

Secondary Outcome Measures

Name	Time	Method
Fat Protein content	Evaluated at experimental day 0,1 and 6 of each intervention	Protein analysis of fat biopsies
Number of symptomatic hypoglycemic events	An average of 1 week	Self-reported events
Incretin hormones	Evaluated at experimental day 0,1 and 6 of each intervention	Incretin hormones GLP-1 and GIP. Incremental and total area under the Concentration-Time Curve
Free fatty acids (FFA)	Evaluated at experimental day 0,1 and 6 of each intervention	Incremental and total area under the Concentration-Time Curve
Fat mRNA	At day 6, and 10 of the study	mRNA analysis of fat biopsies
Pulse	The first 24 hours of intervention and at experimental day 6	Changes in pulse, beats per minute
Glucose regulatory hormones	Evaluated at experimental day 0,1 and 6 of each intervention	Counter regulatory hormones: glucagon, noradrenalin, cortisol, somatotropin, and insulin/c-peptide. Incremental and total area under the Concentration-Time Curve
Blood pressure	The first 24 hours of intervention and at experimental day 6	Changes in blood pressure, mm Hg

Trial Locations

Locations (1)

Steno Diabetes Center CopenhagenSteno Diabetes Center Copenhagen, Clinical Metabolic Physiology; 🇩🇰 Hellerup, Denmark