GIP and GLP-1 in Type 1 Diabetes

Not Applicable

Completed

• Conditions: Hypoglycemia
• Interventions: Other: GIP; Other: GLP-1; Other: Saline

• Registration Number: NCT01739283
• Lead Sponsor: Mikkel Christensen

Brief Summary

Investigation of Glucose-dependent Insulinotropic Polypeptide (GIP) effects at hyper and hypoglycemia in type 1 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-11-17
• Study First Submitted QC: 2012-11-30
• Study First Posted: 2012-12-03
• Primary Completion: 2013-04
• Study Completion: 2013-11
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-10
• Last Update Posted: 2015-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

Inclusion Criteria

• Diagnosed with type 1 diabetes (WHO criteria)

Exclusion Criteria

• HbA1c > 9 %
• Liver disease (ALAT/ASAT > 2 x upper normal limit)
• Diabetic nephropathy (s-creatinine > 130 µM or albuminuria)
• Proliferative diabetic retinopathy (anamnestic)
• Severe arteriosclerosis or heart failure (NYHA group III or IV)
• Anemia
• treatment with medication not applicable to pause for 12 hours
• C-peptide increase after 50 g iv arginine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
hyperglycemia	GIP	Hyperglycemic clamping
hypoglycemia	GLP-1	Hypoglycemic clamping
hypoglycemia	Saline	Hypoglycemic clamping
hypoglycemia	GIP	Hypoglycemic clamping
hyperglycemia	Saline	Hyperglycemic clamping

Primary Outcome Measures

Name	Time	Method
plasma glucagon area under curve values	approx. 15 minutes intervals, time 0 to 120 min

Secondary Outcome Measures

Name	Time	Method
plasma gut hormones and nutrients (absolute, incremental and area under curve values)	approx. 15 minutes intervals, time 0 to 120 min

Trial Locations

Locations (1)

Gentofte Hospital; 🇩🇰 Hellerup, Denmark