Insulinotropic Effect of GLP-1 and GIP After Dexamethasone

Hvidovre University Hospital19 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes

Interventions

DexamethasoneDRUG

Dexamethasone are given dexamethasone tablets of 2mg twice daily.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Bispebjerg University Hospital

Copenhagen NV, Denmark

Outcomes

Primary Outcomes

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.

Time frame: 1-3 days after dexamethasone treatment

Secondary Outcomes

First phase insulin response to GLP-1 infusion at 7mmol/l

Time frame: 1-3 days after dexamethasone

First phase insulin response to GIP infusion at 7mmol/l

Time frame: 1-3 days after dexamethasone

Second phase insulin response to GIP infusion at 7mmol/l

Time frame: 1-3 days after dexamethasone treatment

Data from ClinicalTrials.gov

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