Effect of GLP-1 and GIP on Insulin Secretion in Type-1 Diabetes Mellitus

Not Applicable

Completed

• Conditions: Type-1 Diabetes Mellitus
• Interventions: Other: glucose dependent insulinotropic polypeptide; Other: glucagon like peptide -1; Other: NaCl

• Registration Number: NCT00603031
• Lead Sponsor: Hvidovre University Hospital

Brief Summary

study hypothesis: treatment with GLP-1 and/or GIP is able to potentiate the maximal stimulated insulin secretion even in c-peptide negative type-1 diabetic patients classified as having no residual beta cell function left.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-15
• Study First Submitted QC: 2008-01-26
• Study First Posted: 2008-01-28
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2009-08
• Last Update Submitted: 2011-01-20
• Last Update Posted: 2011-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Age 18-60 years
• Type-1 diabetes diagnosed between 5-40 years of age
• Normal weight(BMI 18-27),
• Insulin treatment from time of diagnosis.

Exclusion Criteria

• Severe complications to diabetes
• Abnormal liver or kidney function
• Haemoglobin below the lower limit
• Macroalbuminuria
• Systemic disease
• Pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GIP	glucose dependent insulinotropic polypeptide	time -30-90 min: Continuous infusion with GIP-1 (3,6pmol/kg/min) time 0-90 min:hyperglycemic clamp(20mmol/L) time 45 min:infusion of L-Arginine (5g).
GLP-1	glucagon like peptide -1	time -30-90 min: Continuous infusion with GLP-1 (1,2pmol/kg/min) time 0-90 min:hyperglycemic clamp(20mmol/L) time 45 min:infusion of L-Arginine (5g).
NaCl	NaCl	time -30-90 min: Continuous infusion with NaCl time 0-90 min:hyperglycemic clamp(20mmol/L) time 45 min:infusion of L-Arginine (5g).

Primary Outcome Measures

Name	Time	Method
phase insulin response and phase insulin response measured as incremental area under the curve from 0-10 minutes and incremental area under the curve from 10-45 minutes respectively after iv glucose	2 hours

Secondary Outcome Measures

Name	Time	Method
maximal insulin response defined as mean insulin at time 47 and 49 minutes (2 and 4 minutes after infusion of L-Arginine)	2 hours

Trial Locations

Locations (1)

Dept. of Endocrinology, Hvidovre Hospital; 🇩🇰 Copenhagen, Denmark