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Insulinotropic Effect of GLP-1 and GIP After Dexamethasone

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02235584
Enrollment
19
Registered
2014-09-10
Start date
2009-07-31
Completion date
Unknown
Last updated
2014-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Incretin hormones, GLP-1, GIP, Dexamethasone

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

Interventions

DRUGDexamethasone

Dexamethasone are given dexamethasone tablets of 2mg twice daily.

Sponsors

Hvidovre University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
The potentiating effects of GLP-1 on second phase insulin response when clamped at at bloodsugar of 7 mmol/l1-3 days after dexamethasone treatmentAfter 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

MeasureTime frame
Second phase insulin response to GIP infusion at 7mmol/l1-3 days after dexamethasone treatment
First phase insulin response to GLP-1 infusion at 7mmol/l1-3 days after dexamethasone
First phase insulin response to GIP infusion at 7mmol/l1-3 days after dexamethasone

Other

MeasureTime frame
Total insulin response to arginine infusion1-3 days after dexamethasone

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026