Beta-Cell Function After Near-Normalisation of Blood Glucose

Type 2 Diabetes Clinical Trial

Official title:

Four Weeks of Near Normalisation of Blood Glucose Improves the Insulin Response to GLP-1 and GIP in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00612950
• Other study ID #: KA 03005
• Secondary ID: KA 03005
• Status: Completed
• Phase: N/A
• First received: January 16, 2008
• Last updated: February 11, 2008
• Start date: October 2006
• Est. completion date: May 2007

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 incretin effect is attenuated in patients with type 2 diabetes mellitus partly due to impaired potentiation of beta-cell responsiveness to glucose by glucose dependent insulinotropic polypeptide and glucagon-like peptide-1 respectively. The aim of the present study was to investigate whether 4 weeks of near-normalization of blood glucose could improve the insulin responses to GIP and GLP-1 in patients with type 2 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: May 2007
• Est. primary completion date: February 2007
• 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 and 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
• Type 2 Diabetes

Intervention

Drug:
• glucagon-like peptide-1,
GLP-1:continuous infusion of ½ pmol/kg/min for a total time of 120 minutes.
• glucose dependent insulinotropic polypeptide
continuous infusion of GIP (1½ pmol/kg/min) for 120 min.
• Saline
continuous infusion of Saline for 120 min

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	2.phase insulin response measured as incremental area under the curve from 10-120 minutes		2 hours	No
Secondary	2.phase insulin response measured as incremental area under the curve from 10-120 minutes, after 4 weeks of insulin treatment		2 hours	No