Insulinotropic Effect of GLP-1 and GIP After Dexamethasone

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Dexamethasone

• Registration Number: NCT02235584
• Lead Sponsor: Hvidovre University Hospital

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2014-06
• Status Verified: 2014-09
• Study First Submitted: 2014-09-07
• Study First Submitted QC: 2014-09-07
• Last Update Submitted: 2014-09-07
• Study First Posted: 2014-09-10
• Last Update Posted: 2014-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dexamethasone	Dexamethasone	This is a before-after study. All subjects are administered dexamethasone 2mg BID for 5 days.

Primary Outcome Measures

Name	Time	Method
The potentiating effects of GLP-1 on second phase insulin response when clamped at at bloodsugar of 7 mmol/l	1-3 days after dexamethasone treatment	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.

Secondary Outcome Measures

Name	Time	Method
First phase insulin response to GLP-1 infusion at 7mmol/l	1-3 days after dexamethasone
Second phase insulin response to GIP infusion at 7mmol/l	1-3 days after dexamethasone treatment
First phase insulin response to GIP infusion at 7mmol/l	1-3 days after dexamethasone

Trial Locations

Locations (1)

Bispebjerg University Hospital; 🇩🇰 Copenhagen NV, Denmark