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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03734718
• Other study ID #: GIPHOT
• Secondary ID: H-18015379
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2020
• Source: Steno Diabetes Center Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2019
• Est. primary completion date: December 12, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Hypoglycemia

Intervention

Drug:
• GIP
Infusion of Glucose-dependent insulinotropic peptide

Locations

Country	Name	City	State
Denmark	Steno Diabetes Center CopenhagenSteno Diabetes Center Copenhagen, Clinical Metabolic Physiology	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
Steno Diabetes Center Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

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