Near Normalisation of BG Improves the Potentiating Effect of GLP-1

Diabetes Mellitus Type 2 Clinical Trial

Official title:

Near Normalisation of Blood Glucose Improves the Potentiating Effect of GLP-1 on Glucose Induced Insulin Secretion in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00612625
• Other study ID #: KF 01 - 198/03
• Secondary ID: KA 01 - 198/03
• Status: Completed
• Phase: N/A
• First received: January 16, 2008
• Last updated: February 11, 2008
• Start date: February 2004
• Est. completion date: December 2004

Study information

• Verified date: January 2008
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The ability of glucagon-like peptide 1 to enhance beta-cell responsiveness to I.v. glucose is impaired in patients with type 2 diabetes mellitus compared with healthy individuals. We investigated whether 4 weeks of near-normalisation og blood glucose improves the potentiation of glucose-stimulated insulin secretion by GLP-1

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 2004
• Est. primary completion date: July 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age 18-70 years

• Type 2 diabetes diagnosed after 30 years of age

• BMI > 25

Exclusion Criteria:

• Severe complications to diabetes

• Abnormal liver og kidney function

• Haemoglobin below the lower limit

• Macroalbuminuria

• Systemic disease

• Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Drug:
• glucagon-like peptide-1
continuous infusion of GLP-1 (1½ pmol/kg/min)
• Saline
continuous infusion of saline

Locations

Country	Name	City	State
Denmark	Dept. of Endocrinology, Hvidovre Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insulin secretion rate (ISR) were derived by deconvolution of c-peptide. ISR is expressed as pmol/kg/min		180 minutes	No
Secondary	The calculated ISR values was plotted against the ambient plasma glucose. The slopes of this linear relationships were calculated by cross-correlation analysis and is and estimation of beta-cell responsiveness (pmol/kg/min)/mmol/l		180 minutes	No