Insulinotropic Effect of GLP-1 and GIP After Dexamethasone

Type 2 Diabetes Clinical Trial

Official title:

Loss of Insulinotropic Properties of Glucagon-like Peptide-1 (GLP-1) and Glucose-dependent Insulinotropic Peptide (GIP) After Glucocorticoid Induced Insulin Resistance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02235584
• Other study ID #: H-D-2009-070
• Status: Completed
• Phase: N/A
• First received: September 7, 2014
• Last updated: September 7, 2014
• Start date: July 2009

Study information

• Verified date: September 2014
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

In this study we examine whether inducing insulin resistance by dexamethasone in healthy volunteers will lead to a decreased insulinotropic effect of the hormones GLP-1 and GIP.

Description:

In this study we are going to examine the insulinotropic properties of GLP-1 and GIP before and after the development of insulin resistance and/or glucose intolerance.The insulinotropic properties of GLP-1 and GIP are greatly reduced in type 2 diabetes.

Since the development of type 2 diabetes is preceded by insulin resistance and glucose intolerance we wanted to examine the insulinotropic properties of GLP-1 and GIP in the early stages of type 2 diabetes.

To do this, we want to induce insulin resistance and/or glucose intolerance. This is achieved by 5 days of treatment with dexamethasone.

Subjects are studied on 4 different days in randomized order, with an oral glucose tolerance test (OGTT) and glucose clamps + infusions of GLP-1, GIP and NaCl before and immediately after 5 days treatment with dexamethasone, 2mg bid. On day 1, 2 and 3 after the 5 days of dexamethasone, 2mg dexamethasone was given in the afternoon after the tests to ensure unchanged insulin resistance

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Caucasians above 20 and below 45 years of age

• Normal glucose tolerance as assessed by the WHO criteria

• First degree relative and at least 1 second degree relative with type 2 diabetes

• Normal haemoglobin

• Informed consent

Exclusion Criteria:

• Liver disease (ALAT/ASAT > 2 times normal value)

• Kidney disease (S-creatinin > 130uM and/or albuminuria)

• Heart disease (NYHA II, III or IV)

• Treatment with medicine that cannot be paused

• Pregnancy of breast feeding

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• Dexamethasone
Dexamethasone are given dexamethasone tablets of 2mg twice daily.

Locations

Country	Name	City	State
Denmark	Bispebjerg University Hospital	Copenhagen NV

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total insulin response to arginine infusion		1-3 days after dexamethasone	No
Primary	The potentiating effects of GLP-1 on second phase insulin response when clamped at at bloodsugar of 7 mmol/l	After dexamethasone treatment subjects are tested with infusion of GLP-1 during a clamped blood-sugar of 7mmol/l. Their increase in the second phase insulin response is the primary endpoint.	1-3 days after dexamethasone treatment	No
Secondary	First phase insulin response to GLP-1 infusion at 7mmol/l		1-3 days after dexamethasone	No
Secondary	First phase insulin response to GIP infusion at 7mmol/l		1-3 days after dexamethasone	No
Secondary	Second phase insulin response to GIP infusion at 7mmol/l		1-3 days after dexamethasone treatment	No