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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03556098
• Other study ID #: H-18002707
• Status: Completed
• Phase: N/A
• Start date: February 22, 2019
• Est. completion date: February 11, 2020

Study information

• Verified date: May 2021
• 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 patients with T1D.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 11, 2020
• Est. primary completion date: February 11, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Hypoglycemia

Intervention

Drug:
• glucose-dependent insulinotropic peptide
Infusion of GIP
• Glucose-Dependent Insulin-Releasing Hormone[3-30]
Infusion of GIP antagonist GIP[3-30]
• Saline Solution
Infusion of Saline

Locations

Country	Name	City	State
Denmark	Steno 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	plasma glucose concentration	plasma glucose excursions and plasma glucose nadir	At times (minute): - 30, - 15, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 on study days
Secondary	Glucose regulatory hormones	Counter regulatory hormones: glucagon, noradrenalin, cortisol, somatotropin, and insulin/c-peptide. Incremental and total area under the Concentration-Time Curve	At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days
Secondary	Incretin hormones	Incretin hormones GLP-1 and GIP. Incremental and total area under the Concentration-Time Curve	At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days
Secondary	GIP[3-30]	GIP[3-30]. Incremental and total area under the Concentration-Time Curve	At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days
Secondary	Free fatty acids (FFA)	Free fatty acids(FFA). Incremental and total area under the Concentration-Time Curve	At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days
Secondary	Blood analysis of paracetamol as an assessment of gastric emptying	Assessment of gastric emptying	At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days
Secondary	Fat mRNA	Fat biopsy to evaluate changes in fat mRNA	At time 240 minute on study days
Secondary	Fat Lipoprotein lipase (LPL)	Fat biopsy to evaluate LPL changes in fat	At time 240 minute on study days
Secondary	Fat Perilipin 4	Fat biopsy to evaluate Perilipin 4 changes in fat	At time 240 minute on study days
Secondary	Fat Fatty acid binding protein 4 (FABP4)	Fat biopsy to evaluate Fatty acid binding protein 4 (FABP4) changes in fat	At time 240 minute on study days
Secondary	Fat Hormonse-sensitive lipase (HSL)	Fat biopsy to evaluate Hormonse-sensitive lipase (HSL) changes in fat	At time 240 minute on study days
Secondary	Fat Vascular endothelial growth factor 4 (VEGF-A)	Fat biopsy to evaluate Vascular endothelial growth factor 4 (VEGF-A) changes in fat	At time 240 minute on study days
Secondary	Fat GIP receptor (GIPR)	Fat biopsy to evaluate GIP receptor (GIPR) changes in fat	At time 240 minute on study days
Secondary	Blood pressure	Changes in blood pressure, mm Hg	At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days
Secondary	Pulse	Changes in pulse, beats per minute	At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days